Upgrading the National Quality Infrastructure
in Georgia
April 15, 2011
The World Bank
with the support of PTB
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Table of Contents
Abbreviations .................................................................................................... iii
Executive Summary ............................................................................................ 1
1. The Role of the Quality Infrastructure in Georgia ...................................... 16
2. The Demand for Quality Infrastructure Services in Georgia ....................... 27
3. The Current Legal and Institutional Framework ......................................... 43
4. The Components of the National Quality Infrastructure ............................ 47
5. Future Needs from Economy, Trade and Society for the Development of the National Quality Infrastructure .................................................................. 68
6. Recommendations..................................................................................... 85
References ....................................................................................................... 92
Appendix A: Survey Questionnaires ................................................................. 95
Appendix B: Additional Information on the Laboratory and Enterprise Survey ....................................................................................................................... 106
Appendix C: Decree on the Establishment of the National Quality Council 109
Appendix D: Structure of the GeoSTM NMI .................................................... 114
Abbreviations
BIPM International Bureau of Weights and Measures (Bureau International des Poids et Mesures)
CE Conformité Européenne
CEN European Committee for Standardization
CENELEC European Committee for Electrotechnical Standardization
CIPM Comité International de Poids et Mesures (International Committee for Weights and Measures)
CIPM-MRA CIPM Mutual Recognition Arrangement
CIS Commonwealth of Independent States
CMCs calibration and measurement capabilities
CRM certified reference material
COOMET Euro-Asian Cooperation of National Metrological Institutions
DCFTA Deep and Comprehensive Free Trade Agreement
EA European co-operation for Accreditation
EASC Euro-Asian Interstate Council for Standardization, Metrology, and Certification
EaP Eastern Partnership
EC European Commission
EMS Environment Management System
ENP European Neighborhood Policy
EU European Union
EUR Euro
EURAMET European Association of National Metrology Institutes
GAC Georgia Accreditation Center
GDP Gross Domestic Product
GeoSTM Georgian National Agency for Standards, Technical Regulations, and Metrology
GNP Gross National Product
HACCP Hazard Analysis and Critical Control Point
IAEA International Atomic Energy Agency
IAF International Accreditation Forum
IEC International Electrotechnical Commission
IFC International Finance Corporation
IFCC International Federation of Clinical Chemistry and Laboratory Medicine
ILAC International Laboratory Accreditation Cooperation
IMF International Monetary Fund
ISO International Organization for Standardization
ITU International Telecommunication Union
JCTLM Joint Committee for Traceability in Laboratory Medicine
KCDB key comparison database
MID Measurement Instrument Directive of the EC
MLA multilateral recognition arrangement
MoED Ministry of Economy and Sustainable Development
MRA mutual recognition arrangement
NAB national accreditation body
NGO Nongovernmental Organization
NIST National Institute of Standards and Technology (United States)
NMI National Metrology Institute
NQI national quality infrastructure
NSB national standardization body
NSD National Standardization Department (Georgia)
OIML International Organization of Legal Metrology
PT proficiency testing
PTB Physikalisch-Technische Bundesanstalt (Germany)
QI quality infrastructure
QMS quality management system
RDI Research, Development and Innovation
SI International System of Units
SME small and medium enterprise
SPS Sanitary and Phytosanitary Standards
TACIS Technical Aid to the Commonwealth of Independent States
TBT Technical Barriers to Trade
UAE United Arab Emirates
UKAS United Kingdom Accreditation Service
WHO World Health Organization
WTO World Trade Organization
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Executive Summary
Key Messages
1. Georgia has transitioned from the post-Soviet state-controlled quality infrastructure. While old procedures are no longer being applied, new procedures in accordance with international requirements are only beginning to be adopted. The implementation of the technical barriers to trade (TBT) and sanitary and phyto-sanitary standards (SPS) strategies, developed during the preparation of the DCFTA negotiations with the EU, could accelerate the process.
2. Currently, only international companies and export-oriented small and medium enterprises (SMEs) are requesting NQI services. The need to position new products in international markets and the incremental harmonization of the Georgian legal situation with EU Directives (New Approach) will increase pressure and accelerate awareness of the need for NQI services.
3. The most critical gap in the NQI is the lack of traceability and reliability of measurement results. Addressing this gap requires finding a suitable building (reconstructed or newly constructed) for the national metrology institute (GeoSTM), acquiring new equipment according to priority needs, training staff in and implementing internationally recognized measurement methods, and hiring young English-speaking physicists, natural scientists, and engineers to balance the age structure of the staff. Cooperation with neighboring countries will help increase technical capacity.
4. The lack of international recognition of GAC’s accreditations for conformity assessment bodies is another obstacle to trade and competitiveness. The training and implementation process should therefore be continued so that international recognition by a peer review of the European co-operation for Accreditation (EA) and the assignment of a mutual recognition arrangement (MRA) or multilateral recognition arrangement (MLA) can be achieved in the next three years for the first types of conformity assessment bodies.
5. The participation of public (ministries and regulatory bodies) and private stakeholders (enterprises, laboratories, consumer and environmental protection bodies, and academia) in the governance of the NQI is weak. This lack of involvement hinders the development of a demand-oriented NQI. The existing Quality Council is a first step, but the council should be strengthened. The main institutions, GeoSTM and GAC, should establish advisory boards in which the main stakeholders and the institutions are equally represented. Implementing mixed technical committees, temporary working groups, and so forth could support the process.
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An internationally harmonized and recognized national quality infrastructure can support Georgia’s better integration into world markets. This infrastructure can contribute to Georgia’s global competitiveness by improving the quality and safety of domestic products and services and by promoting better trade integration with the European Union (EU) through lower technical barriers to trade (TBT). Compared with other small countries (Bulgaria, the Netherlands, and UAE), Georgia’s proportion of trade in GDP is very low. Georgia has yet to exploit the full potential of the international division of labor. Some of the more sophisticated imports that Georgia exports to the CIS (e.g. pharmaceuticals and chemical products) do not yet occupy a prominent position among exports to the EU. Many of the products exported to the EU are unprocessed goods. Georgia can improve its trade competiveness with higher value-added products with the EU by ensuring that it meets the quality and standards of those markets. It can meet its societal needs and stimulate the tourism industry by ensuring that it has the infrastructure to implement environmental production, health, safety and food standards. The term national quality infrastructure (NQI) denotes the complete public and private infrastructure required to establish and implement the standardization, metrology, inspection, testing, certification, and accreditation services to prove that products and services meet defined requirements, whether demanded by authorities or by the market. The two main NQI institutions in Georgia are the Georgian National Agency for Standards, Technical Regulations, and Metrology (GeoSTM) and the Georgian Accreditation Center (GAC). This study outlines institutional and legal changes needed to harmonize the Georgian NQI with EU norms address quality gaps in enterprises. In particular, it identifies gaps in the technical capacity of the NQI with respect to the requirements of the EU DCFTA and requirements that support export competitiveness. It defines current and future needs for NQI services and provides recommendations for policy and investment priorities to develop a demand-oriented basic NQI in Georgia. The conclusions and recommendations of the study can support the implementation of the country’s TBT strategy, which is also linked to the Sanitary and Phytosanitary Standards (SPS) strategy. The study was supported by the German National Metrology Institute (Physikalisch-Technische Bundesanstalt, or PTB) and the EU TACIS Project. This study was conducted in the context of Georgia’s preparation of Deep and Comprehensive Free Trade Agreement (DCFTA) negotiations with the EU, and Georgia’s recent departure from the Commonwealth of Independent States (CIS). The critical challenges of Georgia’s NQI are
(a) The lack of traceability and reliability of measurements,
(b) The lack of international recognition of conformity assessment certificates, and
(c) The weak stakeholder participation in the development and governance of the NQI.
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Georgian enterprises make uneven use of the NQI, with one important segment having very limited understanding of modern quality practices. The inquiry study presents a differentiated picture of awareness and demand for NQI services by the 117 enterprises and 77 testing and calibration laboratories that were included in the survey. The survey reveals that the implementation of quality management systems (QMSs) and the demand for measurement instruments with international traceability depend on the requirements of the existing or intended market. The companies and laboratories are representative of the current economic structure, but the sample emphasizes potential export sectors and other sectors more likely to make use of the NQI. For a more complete picture of NQI needs, the survey included infrastructure services (electricity, water, electricity, and transports), construction, health care services (clinics and clinical laboratories) and environmental protection. A first group of enterprises consists of international companies and export-oriented domestic SMEs. These firms understand the importance of implementing a QMS, of applying international standards (International Organization for Standardization, or ISO; International Electrotechnical Commission, or IEC; and others), and of using reliable and traceable measurements. They find their own means to source missing calibration competences in GeoSTM and the lack of confident testing results in the country, which means increasing costs and complicated logistics because they must contract for these expensive services abroad. A second group includes SMEs that produce for the domestic market. They conducted their last metrological verification in 2005 (when verification was still mandatory), and they show no demand for voluntary NQI services for cost reasons. A third group of SMEs lacks adequate knowledge and awareness about modern QMSs, standards, and testing. Some of them were unaware of GeoSTM’s existence. Within the companies surveyed, less than a quarter have certified management systems (ISO 9001, 14000, 22000). Another 50 companies intend to integrate international management system requirements into their operations, whereas many companies reject the idea because of their difficult financial circumstances or the absence of relevant client and legal requirements. The motivations of companies to introduce management systems can be linked to client requirements and the willingness of export-driven companies to improve competitiveness. Less than 50 percent of the sample have used GeoSTM’s metrology services, and very few use the services of private independent calibration or verification laboratories. The majority of the in-house laboratories do not acknowledge the need for calibration or verification of their equipment. Modern measurement methods and terminology are practically unknown and are not understood. The companies identified the following obstacles that private companies face regarding the metrology services of the GeoSTM:
Limited number of and lack of information about services provided by GeoSTM.
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Lack of appropriately equipped technical facilities, unavailability of reference materials, and lack of qualified personnel.
Inadequate technical capability of regional services (for example, Rustavi and Batumi).
The surveyed companies demonstrate needs that were not obtaining from GeoSTM:
Improved access to and provide updated information.
National standards harmonized with international standards.
Accurate translations of international standards. Only a few of the visited laboratories are really fit for accreditation by international standards or can prepare this accreditation without many investments, training, internships, and coaching. The laboratory survey covered accredited and non-accredited testing laboratories. Until 2009, laboratories in Georgia were accredited by GAC in accordance with the European EN 45001 standard requirements. Starting in 2010, laboratories are now being accredited in accordance with the latest international standard, ISO/IEC 17025. Because laboratory accreditation is not mandatory for testing services, the majority of the interviewed laboratories were motivated by customer requirements for accreditation. Yet several companies applied for accreditation of their laboratories to acquire their competences assessed by a third party and to gain higher confidence from their clients. Generally, the laboratory personnel have only a partial knowledge of modern testing methods. For instance, only 10 percent of staff members at the interviewed laboratories claimed that they are aware of the problem of measurement uncertainty. Approximately one-fourth of all surveyed commercial and in-house laboratories mentioned not being able to ensure environmental conditions (temperature and humidity) required for accurate laboratory testing. Observations by the interviewers suggest that this share is higher and that the conditions also include dust and other elements. Georgia’s legal and institutional framework established in 2004–05 does not fully correspond to the international requirements for best practices and urgently needs adjustments. When the current legal and institutional framework was introduced in 2004–05, GeoSTM was created with a National Standardization Department (NSD) and a National Metrology Institute (NMI). Standardization and metrology were not separated into independent institutions as done in most countries with internationally-harmonized NQIs. Moreover, within the NMI, there is no clear administrative separation between scientific and applied metrology, industrial metrology (calibration services for industry), and legal metrology. Thus, the two bodies are referred to by enterprises and laboratories as “Gosstandart”, the Soviet state-controlled NQI (Gosstandart), which was
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based on the top-down control of quality and standards through mandatory requirements for a wide range of goods. During the reform process, the most important laws were amended, and mandatory measurement device verification from the former Soviet regime was abolished. GAC was founded as a new institution, and both it and GeoSTM are nonprofit legal entities under public law, reporting to the Ministry of Economy and Sustainable Development (MoED). The main result of the reforms was the destruction of the post-Soviet state-controlled NQI (Gosstandart). But the new legislation only partially corresponds to international requirements and hinders the establishment of an efficient system of calibration and dissemination of internationally recognized traceability. Within the government, the vertical responsibilities for the quality infrastructure (QI) are clarified and lie in the hands of MoED, but the horizontal coordination with the line ministries and regulatory bodies is not regulated. The main public (ministries and regulatory bodies) and private stakeholders (enterprises, laboratories, and consumer and environmental protection organizations) have limited influence on the development of the NQI. These problems hinder the development of demand-oriented NQI institutions. The existing Quality Council in which all the important stakeholders are represented is a first step. Objectives, tasks, and responsibilities are defined, but until now a permanent agenda has not been defined nor has the Quality Council been actively involved in the development of the NQI. The main institutions—the NMI within GeoSTM, the NSD within GeoSTM, and GAC—can be made more effective by establishing advisory boards, in which the main stakeholders and the institutions are equally represented. If there are legal obstacles, respective changes must be made to reformulate the legal base. The implementation of mixed technical committees, temporary working groups, and so forth could support the process. Metrology and the NMI within GeoSTM represent the most critical point of further development and international recognition of Georgian NQI institutions. The importance of metrology as the technical base for the NQI and the need for investment in the NMI were underestimated in the beginning of the reform process. In contrast to standardization and accreditation—which need consulting and training services, internships, and practical experience, but few investments—metrology requires modern equipment to ensure traceability to the International System of Units (SI). This service is a public good, and its access by all interested parties must be assured, by SMEs in particular, which do not have the same ability as large enterprises to organize measurement traceability abroad. Significant gaps are as follows:
The staff is aged; the vast majority, about 51 percent, is over age 50. Both the young staff members and the more experienced metrologists who could replace the laboratory heads in future years are missing.
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In most laboratories, the equipment is obsolete and lacks traceability. Even simple devices like balances and manometers must be sent abroad for calibration, tripling expenditures for calibration by transportation costs and custom fees.
The NMI building is in poor condition and is too large. The environmental conditions (in particular, climate control and power supply) are unsuitable.
For many years, Georgian metrology institutions had no contact with the international metrological organizations. GeoSTM joined the regional metrology organization, the Euro-Asian Cooperation of National Metrological Institutions (COOMET) in 2006. In 2009, it became an associated member of the international metrology institution, the International Bureau of Weights and Measures (Bureau International des Poids et Mesures, or BIPM). It is not a member of the International Organization of Legal Metrology (OIML), which is important for the development of the legal and institutional framework of metrology.
The link between GeoSTM and potential customers and stakeholders (ministries other than MoED, enterprises, and laboratories) is rather weak. This issue makes setting investment priorities and handling complaints difficult. The formation of an advisory board representing the NQI stakeholders, including GAC and NSD, would be very helpful.
The development of a QMS in conformity with the latest international laboratory standards (ISO/IEC 17025:2005 and ISO Guide 34:2009), which is important for international recognition of GeoSTM´s measurement capabilities, is only in its initial phase.
There is no coherent development strategy for the NMI for organizational and personnel development, marketing (development of services), and financing.
In recent years, metrology has shown an initial improvement thanks to the support of the EU TACIS project, PTB, and MoED. The first results are the installation of laboratories of mass and of physical-chemical units according to international standards, participation in internships and training activities in and outside Georgia, and participation in bilateral and multilateral comparisons. An important weakness in Georgia’s standardization system is its limited linkages to stakeholders. According to its staff and mandates, the NSD within GeoSTM meets international best practices, but relationships with clients are still weak. Only 15 percent of the standardization work is reportedly made upon request of the private sector. Standards are voluntary in Georgia. The NSD within GEOSTM has a qualified staff of about 16 persons and is well equipped. Although GeoSTM is named “Standardization, Technical Regulations and Metrology,” it has no mandate to develop technical regulations except in the metrology field. The agency is a corresponding member of ISO and IEC, and is an affiliate of the European regional standardization bodies—the
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European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC).1 Important weaknesses are related to the few links to the stakeholders: only two technical committees are actually working. The NSD services are insufficiently disseminated and unknown, and there is no supervisory board representing the main public and private stakeholders and developing standardization policy. Georgia’s accreditation system requires more organizational changes and technical capacity to become internationally recognized. GAC is a young institution, in operation since 2006. It was strongly supported by international projects. A certain consolidation of the technical competence of the staff can be observed, but it needs continuing, permanent efforts to improve, in cooperation in particular with the NMI, to obtain international recognition through the assignment of a MRA, MLA, or both. GAC has accredited some 150 conformity assessment bodies, of which about 90 calibration and testing laboratories still operate by the obsolete EN 45001 European standards. The large number of accreditations in such a short time raises questions about the quality and credibility of the accreditation process up to 2009, and in particular of the documentation of measurement traceability, the estimation of uncertainty, and the assessment of the environmental conditions (temperature, humidity, dust, etc.). The intensification of training allowed four laboratories to be accredited in the first months of 2010 in conformity with the latest international standard, ISO/IEC 17025. Older GAC staff members and lead assessors are not sufficiently familiar with the international ISO/IEC 17025 criteria and the way the ISO standard is implemented. In particular, they do not understand issues like traceability and measurement uncertainty, crucial elements for international recognition of measurement and test results. GAC accreditation of laboratories is based on traceability obtained from GeoSTM in the form of legal verification. This practice is not in compliance with the ISO/IEC 17025 standard and will delay GAC’s international recognition. An organizational structure in accordance with international requirements was not implemented at the time of the study. Two crucial missing elements are (a) an accreditation board with participation of the stakeholders and NQI institutions (NMI and NSD), which will advise the ministry on accreditation; and (b) technical advisory committees. Furthermore, cooperation with NMI for contracting experienced metrologists to assess the process of calibration and testing laboratories is not regulated and produces unnecessary conflicts.
1 The CENELEC affiliation became official in the first week of June 2010.
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GAC has applied for a contract of cooperation with a European regional accreditation organization, EA. Once GAC signs an EA MLA for mutual recognition of accreditation, GAC can become a full member of the International Laboratory Accreditation Cooperation (ILAC) (currently, GAC is an affiliate member) and have its accreditations recognized worldwide. Georgia has taken important steps towards the development of technical regulations system, but much remains to be done to have a well-functioning system to develop and enforce them. Prior to the QI reform in 2005, technical regulations, inspections, and market surveillance were not sufficiently regulated and did not correspond to EU practices. Technical regulations were introduced as the legal instrument replacing mandatory standards, by which all compulsory product-related requirements regarding recognized and legitimate objectives (safety, health care, environment, and consumer protection against deceptive practices) are stipulated and enforced. Since 2005, some technical regulations were adopted in the fields of transport and hazardous industrial equipment, while food inspections were completely abolished. Because of the lack of clear responsibilities for technical regulations and of limited technical competences, Georgia decided to recognize the technical regulations of 25 EU countries, Israel, and 10 Organization for Economic Co-operation and Development (OECD) countries “including all EU Directives in accordance with the New and Global Approaches” and to “allow for their application in the territory of Georgia” (Governmental Resolution 45 of 2006). In practice, the recognition of these technical regulations seems to mean that products from the respective countries are admitted into the country either without further formalities and conditions or, in the case of products covered by New Approach directives, if the Conformité Européenne (CE) marking has been affixed. Until recently, market surveillance for industrial goods was carried out by the Architectural-Construction Inspection and the Technical Supervision Inspection. Although it is difficult to have a clear picture of the future economic and social developments of the country, current and future needs for QI services are most in demand in a number of sectors. These include:
• Alcoholic (wine, beer, liquor, and so forth ) and nonalcoholic beverages (mineral water, juice, soft drinks, and so forth)
• Some metals, metallurgy (foreign investments)
• Certified bioproducts (“Green Caucasus”) such as honey, nuts, and tea
• Construction materials (foreign investments)
• Pharmaceutical products and medical devices (generic, regional market)
• Foodstuffs: live animals, fish, processed fruit, and vegetables.
• Apparel (on a subcontracting and boutique basis, Turkish subsidiaries).
• Chemicals
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• Glass and paper (packaging)
• Energy: improvements in energy efficiency and integration into the European electricity transmission network without accurate metering and harmonized standards are very difficult. This sector also includes the transportation and distribution of gas, oil, and derivatives.
• Construction: establishment of a better communication infrastructure (Turkey, South Caucasian countries). The appliance and adoption of international construction standards, measurements, and testing methods will be very important.
The following areas will also request an increasing number of QI services:
• Transport and logistics: transit of gas, oil, and other products among European and Central Asian countries will need to be addressed.
• Health care: in the next few years, improving the accuracy of clinical tests will gain importance (diminishing costs of treatment). Requirements for certified reference materials and better testing methods (standards) will increase. Cooperation with international associations is required because one country cannot maintain all the measurement standards.
• Food safety: DCFTA requires the implementation of the European standards for food processing from farm to fork. Harmonization of standards, technical regulations, and testing methods is necessary. SPS strategy is linked to the development of the NQI.
• Consumer and environmental protection: water, soil, and air pollution in the form of noise has also become a problem in Georgia. These types of pollution need standards and improved measurement such as the step-by-step introduction of devices subject to state control or inspections (water meter, energy meter, etc.).
At the moment, the most critical gap for the international recognition of Georgian conformity assessment certificates is metrology. Although initial steps have been taken, the national measurement standards with traceability to the SI must be continuously improved according to the most urgent needs of Georgian economy and society. Investment is needed in equipment, but in particular in an appropriate building that provides the necessary environmental conditions and sufficient power supply for accurate measurement. The government must decide whether (a) the current building will be reconstructed, (b) another adequate building will be reconstructed, or (c) a new building will be constructed. The possibility of designating one or more expert laboratories to act as a NMI in a well-defined field of metrology where GeoSTM does not have proficiency should be examined in the near future. This designation is possible in the fields of electricity and metrology in chemistry, and it would accelerate the process of obtaining internationally recognized traceability, diminish the investment costs, and improve the competitiveness of Georgian SMEs in international markets.
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The results of the demand survey and assessment of GeoSTM/NMI show that the following measurements have priority: Temperature, Electricity, Pressure, Mass, Volume, Length, Density and pH. If one considers future economic and social development, some other measurements will be also important, including: Force, Gas mixtures and gas analyses, Reference materials and certified reference materials. The scope of the physical-chemical laboratory should be defined, including a program of desirable certified reference materials (CRM), CRM certification, and proficiency testing (PT) scheme reference value assignments. Possibilities for establishing cooperation with other CRM producers should be investigated. GeoSTM should help the Ministry of Health establish links with the Joint Committee for Traceability in Laboratory Medicine (JCTLM) community and assist in the development of clinical reference laboratories in Georgia. International harmonization of the NQI will require legislative changes. The gaps and weaknesses in the legal and institutional framework are defined in the TBT strategy, which must now be implemented step-by-step. In this context, the planned new formulation of the NQI laws as a unique and complex code of laws should include advice from international experts who know not only international best practices, but also existing trends in international organizations (OIML, ISO/IEC, ILAC, the International Accreditation Forum (IAF), etc.). The laws should be based on the terminology of the ISO/IEC 17000 series. An important aim of the TBT strategy is to introduce the most important EU Directives. A consequent implementation and a continuous adjustment of the priority list corresponding to the development of the real demand in Georgia are needed. The initiated reorganization of legal metrology should be continued,2 and the planned foundation of a market surveillance authority realized. A separation of the NMI and the NSD as independent bodies in the medium term can achieve the best governance results. At minimum, if the two remain housed in the same institution, responsibilities, budget and decision making processes need to be completely separated and independent. In the case of technical regulations and market surveillance, new framework legislation on general product safety and producers’ liability for defective products should be rapidly developed and implemented and the necessary personnel adequately prepared. The role of government market surveillance should be strengthened. The capacity of line ministries to develop, adopt, and implement technical regulations should be strengthened. Interdisciplinary and interministerial working groups for developing and implementing priority technical regulations should be established.
2 A good example is the amendment to the measurement law, which defines a small number of
measurement instruments that are subject to legal metrology. Although the list may appear incomplete, it is a start to a solid introduction of legal metrology on a new, non-Soviet foundation.
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Effective mechanisms should be introduced to ensure food safety (balanced checks along the entire value chain and proactive market surveillance). This process means, among other things, legal acts and the training of market inspectors in international and EU surveillance methodology and practice. National awareness and stakeholder participation can be key pillars of a more effective NQI. National awareness of the functioning of the NQI and its importance for Georgian economic competitiveness and improvement of Georgian quality of life can be increased through appropriate activities for all interested parts of society: policy makers, entrepreneurs, academia, and consumers. The implementation and further development of the TBT strategy and a NQI in accordance with international rules and national conditions require strengthening the participation of stakeholders in this process. Two steps are important: (a) to transform the Quality Council into an active advisory board for the government for the implementation of the TBT strategy and the development of the NQI; and (b) to establish supervisory boards in the NMI, the NSD, and the National Accreditation Body (NAB) in conformity with international best practices with representatives of the stakeholders to ensure a balanced development in their respective areas. A very weak point in the Georgian economy is consumer protection. The abolishment of most inspections, weak nongovernmental organizations, and missing governmental and mass media information leave the consumer without much orientation or help. Also, until now the market in Georgia has been preferentially a price market, not a quality market. Enterprises and laboratories are eager to receive training and consulting in metrology (calibration, uncertainty), standardization, and accreditation. They ask for better and more timely information about new developments and for the modernization of information instruments (website, electronic information materials, and so forth). The services offered by the NQI institutions should be developed in accordance with demand-oriented needs and disseminated by adequate marketing methods. The further development of the NSD within GeoSTM requires a closer relationship to stakeholders, a consequent improvement of management structures, and the development of standards collection according to the needs of national clients. A homogeneous and consistent collection of national standards that adequately serves the needs of standards users, legislators, conformity assessment bodies, and enforcement authorities alike should be created progressively. This gradual implementation implies phasing out obsolete GOST (Gosudarstvennyy standart, or state standard), adopting European standards in priority sectors, and gradually abolishing the practice of registration of company specifications.
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An adequate technical committee structure for standardization work in priority sectors (to mirror committees to the ISO/IEC technical committees) should be established. The standardization governance and management structures (executive body, technical committees, subcommittees, and working groups) should be reviewed. They should have the highest possible degree of autonomy concerning the technical issues at stake. Building technical capacity for international recognition should start now, as the process will take time. The GeoSTM standardization technical staff should be trained in best standardization practices, work procedures, organization and management of the technical work, and the use of information and communication technologies tools for standardization purposes. The concept of a modern technical officer should be introduced. GAC should rapidly develop its competence to accredit calibration and testing laboratories in accordance with ISO 17025:2005 requirements. This competence requires further training of GAC staff in ISO/IEC 17025 and specific training in understanding traceability and measurement uncertainty. GAC staff must also be further trained to understand and properly implement the accreditation standards (ISO 17011, ISO/IEC 17025, ISO Guide 34, and other ISO Committee on Conformity Assessment standards). Practical training abroad and practical implementation accompanied by a coaching process could improve this situation. In addition, GAC should encourage GeoSTM to organize PT schemes for accredited and nonaccredited calibration and chemical analysis laboratories, as well as for CRM producers. It is critical to attract young English-speaking people with development potential to the NQI institutions. Emphasis should be given to the NMI (six to eight already in 2010) because of its unbalanced age structure. Not only are better salaries needed, but also good working conditions, a pleasant working atmosphere, and interesting professional development prospects. The existing deficiencies in the qualification of the staff members in all the relevant NQI institutions require continuing education for them. The rapid development of standards, methods, policies, and best practices around the world also require continuing education of those staff members. An important point is the combination of improvement of theoretical knowledge with practical appliance, exchange of experiences and best practices, internships, and coaching. In the case of GeoSTM, obtaining international recognition implies the preparation and realization of calibration and measurement capabilities (CMCs), the implementation of a QMS conforming to ISO/IEC 17025, and the special requirements for NMIs. In the case of GAC, training, internships, and a consequent application of the relevant ISO/IEC standards in the accreditation process in Georgia are needed. The NMI within GeoSTM and the GAC should build and implement a development strategy.
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The strategy should define the steps needed to obtain international recognition by peer reviews of the respective international organizations in the near future, GeoSTM by signing the International Committee for Weights and Measures (Comité International de Poids et Mesures, or CIPM) Mutual Recognition Arrangement (CIPM-MRA), GAC by signing the MRA/MLA of ILAC and IAF). The three institutions, the NMI within GeoSTM, the NDS within GeoSTM, and GAC, should develop and implement business plans. Such plans are required to strengthen internal organization, make best use of limited financial resources, and develop services for different clients of the system, and should take financing, marketing, and personnel development into account. In this context, the contributions of the state budget and financing from services and projects must be defined. In the case of the NMI, the custody and development of the national measurement standards is a public good which in all countries is maintained overwhelmingly by the state budget. In most countries the accreditation body initially benefits from state budget support, until it becomes internationally recognized and develops a market. In most countries, the national standardization activities are not financially sustainable and require additional sources of revenue. International recognition will require international cooperation through a number of channels. Georgia is confronted with challenges that call for international cooperation and division of labor. The existing relationships with NQI institutions in Turkey, Ukraine, and some EU countries (the Czech Republic, Germany, Lithuania, and the Slovak Republic) should be strengthened and used to accelerate the development of Georgia’s NQI. In addition, GeoSTM could develop a leading role in the metrology of electricity and radiometry in the South Caucasian and Central Asian region. The development of memberships in the most important regional and international NQI organizations is indispensable. COOMET, BIPM, OIML, ISO/IEC, CEN/CENELEC, EA, ILAC, and IAF are important institutions in which Georgia must actively participate. With the exception of OIML, Georgia already has relationships with all of them. However, active participation in these organizations, including their technical committees and working groups which are relevant for Georgia is required in order to improve the technical competences and to achieve the aim of international recognition. Georgia can also exploit economies of scale and reduce costs in the development of its quality infrastructure by coordinating on the development of technical capabilities such as laboratories and training, with neighboring countries. Georgia can specialize on capabilities that are not available in other countries and vice-versa. The state will need to catalyze the development of a market for testing and calibration. The testing and calibration laboratories as important parts of the NQI need better and more extensive training in international testing methods and QMSs (ISO/IEC 17025) to
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be accredited in conformity with ISO/IEC 17025. Some of them need upgrading of measurement devices and improvements of their environmental conditions. For support and acceleration of this process, international cooperation and public promotion programs would be useful because the efforts required to become accredited according to ISO/IEC 17025 are high and probably involve voluminous investments in some laboratories. Moreover, training and consulting, which cannot be done by GAC because of a conflict of interest, for the accreditation process should be promoted. The government should explore opportunities for attracting foreign investors in the area of conformity assessment. The laboratories should participate in a more direct and active way in the NQI development process, in particular by the participation of their representatives in the Quality Council and the different supervisory bodies and committees. The development of the foundation and of laboratory associations could strengthen this development. Their links to the relevant international organizations should be promoted. For improvement of the competitiveness of Georgian SMEs in the international and domestic markets, SME demand for QMS must also be encouraged. In this case, loan or matching grant programs could improve awareness of quality issues in the enterprises and promote value-added production. To summarize, there are several immediate opportunities for implementing low-cost measures that can yield benefits to the economy:
Aligning the NQI legislation with international requirements with consultations from international experts.
Developing market surveillance legislation which provides a strengthened role for the government.
Increasing the participation of public and private stakeholders in the governance of the NQIs through advisory boards and by increasing the activities of the Quality Council.
Clarifying the organization of the technical regulations, consumer protection and market surveillance system
Designating existing laboratories outside of GeoSTM as national metrology institutes where appropriate to diminish investment costs.
Georgia can also start investing now in capabilities that will take at least 5 years to gradually build:
Creating a development strategy for the NQI institutions.
Developing the technical capacity of the national metrology institute and seeking international measurement traceability.
Upgrading the facilities of the national metrology institute or find more adequate facilities.
15
Building staff and organizational capacity in all NQI institutions.
Seeking membership in international NQI organizations.
Raising awareness for NQI needs in the private sector.
Building technical capacity for quality upgrading and quality services in the private sector.
Developing new accreditation scopes or attracting a foreign accreditation body for certain scopes.
Seeking multilateral recognition in the area of accreditation.
Strengthening the capacity of the ministries to develop, adopt and implement technical regulations.
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1. The Role of the Quality Infrastructure in Georgia
1.1. The Quality Infrastructure in a Global Economy
Measurements, standards, and testing are important elements for assuring the quality of industrial products. They constitute a technical basis for trade in commodities and goods, and in consumer, health, and environmental protection. Producers and consumers regularly use components of the quality infrastructure (QI), often without
realizing that they are doing so. 3
In a globalized economy, the QI is gaining importance because of several trends:
Global trade in food products
Global spread of diseases
Global environmental and climate issues
Global trade in commodities
Global value chains of industrial and service activities
A well-organized and reliable QI is a precondition not only for international trade, but also for environmental protection, health care services, and food safety because they require standards, measurements, and reliable tests. Standards support compatibility and diminish costs using equal specifications, and methods; they are important for creating new industries and using new technologies; and they are key to accessing new markets and maintaining market share. During the past few decades, concepts of quality have gained much importance. Consumers are requesting higher levels of security, reliability, sustainability, and better functionality of products and services. Globalization of the world economy has resulted in product components (for example, car parts) being produced all over the world, then being shipped to other factories for assembly into the final product. This process requires standardization; a high level of measurement and testing; and a network that secures reliability, comparability, and confidence. This growing network has national, regional, and global dimensions and is composed of many public and private actors working directly or indirectly together. Economic growth requires not only a physical infrastructure (like roads), production and transmission of energy, or basic services (like education and health) for its evolution, but also a network of institutions ensuring the quality of products and services and a minimum of quality of life. In past years the term quality infrastructure has been increasingly used. The concept of QI implies that each country needs a basic framework of such institutions that correlates with regional and international networks if economic and social development is to be made sustainable. Some parts of the QI are public goods, for instance, the
3The introduction builds on some interesting publications of the past few years. Most important are BIPM
(2003), Guasch et al (2007), ISO/UNIDO (2009), Sanetra y Marbán (2007).
17
custody and maintenance of the most important national measurement standards (as a part of the metrology) (Swann 2009; Tassey 2008). For this reason, national metrology institutions (NMIs) like the National Institute of Standards and Technology (NIST) in the United States, the Physikalisch-Technische Bundesanstalt (PTB) in Germany, and the National Institute of Metrology, Standardization and Industrial Quality (Inmetro) in Brazil are mainly state financed (budget and projects). Typically, but depending on the local situation with respect to income earned by the NMI with calibrations, consultancy and training courses, the Government pays 60 to 90 % of the yearly budget of the NMI. The quality infrastructure4 can be defined as the combination of the institutional network, either public or private, and the legal framework that
Regulates, formulates, edits, and implements standards (that is, establishes rules for the common and repeated use of standards to obtain an optimal order in a given context considering current and potential problems).
Provides evidence of its fulfillment (that is, a relevant mixture of governmental market surveillance, inspections, tests, certification, metrology, and accreditation).
The QI has the aim of improving the equivalence of products, processes, and services for desired purposes; of impeding commercial barriers; and of facilitating technical cooperation. Figure 1 provides a schematic view of the different economic and social objectives that draw on the NQI.
4In earlier publications, the term MSTQ (metrology, standardization, testing, quality assurance) is also
used. The term QI is broader and emphasizes the networking between the different actors. It is also open for new aspects and appearances.
18
Figure 1: Requirements for the Development of the NQI
NQI Requirements
National
Context
International
Context
Economic Structure,
Development and
Competitiveness
International
Economic Relations
and Agreements
Food Safety Environmental
ProtectionHealth
Efficient
Production and
Use of Energy
Water Supply
and Treatment
Scientific
Research &
Development
Innovation
Consumer
Protection
Security
During the last decades of the 20th century, the services necessary for satisfying this demand formed a QI that comprises the following important elements:
Standards and technical regulations: the formalized documentation that determines the requirements that a product, process, or service must fulfill. Essentially, the standards are considered voluntary; only if they are agreed upon in a conformity contract will they be transformed to an obligatory requirement. If the state transforms them in technical regulations for public security or health reasons, they will become mandatory.
Metrology: the technology and science of measurement. Usually, metrology is subdivided into Scientific and applied metrology, which describes and disseminates the
measurement units
Industrial metrology, which guarantees by calibrations the adequate working of the measurement instruments used in production and in tests
Legal metrology, which secures the accuracy of the measurements in those cases that influence the transparency of economic transactions in trade, health care and security issues.
Testing: the determination of the characteristics of a product in comparison with the requirements of a standard. Tests can vary from a simple visual or nondestructive evaluation (for example, tests with x-rays or pressure tests after which the products
19
can be used) to a totally destructive analysis (for example, chemical, mechanical, physical, or metallurgical tests after which the products cannot be used anymore) or any combination of both.
Certification: the formal verification that a product, service, management system of an organization, or competence of a person corresponds to the requirements of a standard.
Inspections: the examination of the design of products, services, procedures, and installations and the evaluation of their conformity with general or specific requirements in the form of laws, technical regulations, standards, and specifications. Private clients, organizations, and state authorities may contract for inspections.
Accreditation: the independent confirmation of the (technical) competence of an individual or an organization that delivers specific services (for example, calibrations, tests, certifications, and inspections).
All these elements are interrelated and must provide—up to a certain point—adequate confidence to the buyer, user, or authorities that the product, process, or service conforms to expectations (Figure 2).
20
Figure 2: The National Quality Infrastructure with Its Relationship to the Value Chain and the Regional and International Quality Infrastructure
Source: PTB presentation. Note: BIPM = International Bureau of Weights and Measures; CE = Conformité Européenne; CENELEC = European Committee for Electrotechnical Standardization; CODEX = Codex Alimentarius; COOMET = Euro-Asian Cooperation of National Metrological Institutions; EA = European co-operation for Accreditation; HACCP = Hazard Analysis and Critical Control Point; IAF = International Accreditation Forum; ILAC = International Laboratory Accreditation Cooperation; ISO = International Organization for Standardization.
The QI is a network of many elements that are important for different aspects of economic, social, and scientific development. It is a system with many actors, stakeholders, and interested parties:
Government and its regulatory agencies
Micro, small, medium, and large enterprises that produce goods, and their organizations (chambers of commerce and business associations)
Trade partners
Service providers
Calibration, testing, and clinical laboratories and their associations
Consumers represented by consumer protection nongovernmental organizations (NGOs)
Environmental protection NGOs
AccreditationISO 17021
IAF ILAC
EA
ISO 17025
ISI 15189
ISO 17025
ISO 15195
StandardizationISO CODEX
CENELEC
Testing
LaboratoriesIntercomparisons
Proficiency Tests
MetrologyBIPM
Tra
ceab
ilit
y
COOMET- Calibration Laboratories
Certification
- Products
- Processes
Country Region / World
ISO 9000, ISO 14000, HACCP, etc
Product Certification, CE, GS,
National, regional,
international standards
Calibration of instruments
Tests, analysis,
research
Reference Materials
Inspections
ISO 17020
Market/ Client
Inspection Bodies
Product/
Service of
Quality,
With
internationally
recognized
certificate
Value
Chain
21
Academic institutions
Investigation, development, and innovation institutions
The QI network is very complex and dynamic with many public and private stakeholders. The main efforts of the past few years consisted of establishing rules and making the system transparent, comparable, and reliable. The central instruments are the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) standards and guidelines and the mutual recognition arrangements (MRAs), and the multilateral recognition arrangements (MLAs) within the international organizations, which secure the conditions for international recognition of measurement and testing results and the results of inspections and certifications. The QI has three basic elements (Table 1). One is the National Metrology Institute (NMI). In most countries, it is a public institute with its own state budget. If the NMI is managed by the private sector, its obligations (for example, custody and maintenance of the national measurement standards and representation of the country in international organizations) and those of the state (financial means) are usually specified in a contract. Second, in many countries the national standardization body (NSB) is an entity of private law, but with participation of the state in the executive council. Third, the national accreditation body (NAB) is usually a private entity with state participation, receiving some state financial support, and its activities are regulated by the legal framework of the QI. State bodies also exist in a legal form that guarantees that the state cannot intervene in technical decisions. Public-private partnership within the NAB is important.
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Table 1:The Three Basic Elements of a National Quality Infrastructure
National Metrology Institute (NMI)
National Standardization Body (NSB)
National Accreditation Body (NAB)
• Typically an institution of the Central Government under the jurisdiction of the Ministry of Economy or Trade (sometimes the Ministry of Science and Technology).
• Secures the dissemination of the international system of units (SI) and the traceability of the measurements to the definitions of the SI.
• Provides traceability to the laboratories of Legal Metrology, industry, research institutions.
• Calibration is voluntary. Verification is obligatory.
• In some countries a private institution which is self-financed by the development and the dissemination of standards. They have technical committees in which all stakeholders interested in developing standards are represented.
• The standards developed by the NIS have a voluntary character.
• They can be referred to by technical regulations which are obligatory.
• This institution is independent of the others to secure the independence of its decisions about accreditation.
• The NMI makes its technical experts available for the accreditation process.
• Accreditation is voluntary.
MAIN PRINCIPLE: INDEPENDENCE OF THESE THREE BASIC ELEMENTS.
Source: adapted from PTB presentations. Note: SI = International System of Units.
The three institutions can accomplish their tasks in accordance with international rules and best practices only if they incorporate the following principles:
Political and management independence of the three institutions.
Transparency of each institution’s activities and decisions.
Approved technical competence of each institution’s staff on each level.
Participation of the stakeholders in the development of institutional policy.
Typically, within the governmental structures the three main institutions fall under the direction of a Ministry of Economy or Ministry of Trade; in some cases, they are assigned to a Ministry of Science and Technology. These ministries usually contain a department that develops the main policy guidelines and coordinates the work, supported by the other two institutions. Because the QI is a transversal theme in many countries, interministerial commissions and working groups work to resolve cross-jurisdictional
23
questions. In some countries (for example, Brazil, Ecuador and Costa Rica), a quality council supports the government in developing a coherent quality policy.
1.2. Georgia and the Deep and Comprehensive Free Trade Agreement
The Technical Barriers to Trade5 (TBT) Agreement of the World Trade Organization (WTO) is based on international standards and serves as a reference for member countries’ free trade agreements. The TBT agreement includes the following:
Procedures of conformity assessment
Standards and technical regulations
Exchange of information.
Its intention is to prevent technical regulations and standards from becoming barriers to trade. WTO member countries establish points of information on technical regulations and standards—the TBT Inquiry Points. In many countries, these points are developed in the NSB. In others, the TBT Inquiry Points are developed by the Department of Foreign Trade of the Ministry of Foreign Relations. It seems clear that there is a very narrow relationship between the assignment of free trade agreements and the QI (Figure 3). Only if a country disposes of a basic and internationally recognized NQI does it have the possibility to participate as a partner with equal rights and abilities in trade.
5See World Trade Organization, “WTO Legal Texts,”
http://www.wto.org/english/docs_e/legal_e/legal_e.htm#agreements .
24
Figure 3: Free Trade Agreements and Quality Infrastructure
CS 2010.02.01
2
Physikalisch-Technische BundesanstaltTechnical Cooperation
Global agreements for Free Trade
ISO / IEC /
CODEX / OIML
ILAC
IAF
BIPM
CIPM
WTO
FTA‘s
StandardizationRegulations
AccreditationTraceability
Free Trade
Source: PTB presentation Note: BIPM = International Bureau of Weights and Measures; CIPM = International Committee for Weights and Measures; CODEX = Codex Alimentarius; FTA = Free Trade Agreement; IAF = International Accreditation Forum; ILAC = International Laboratory Accreditation Cooperation; OIML = International Organization of Legal Metrology.
In the case of a Deep and Comprehensive Free Trade Agreement (DCFTA) with the European Union (EU)—which implies a very strong approximation of the trade regime to the EU—the requirements may go much further with the objective of facilitating equal and practically unrestricted commercial relations between the respective country and the EU in given areas. A far-reaching coincidence in the legal and institutional framework with the EU standards and their operation is requested. Because the QI forms an indispensable base for such an agreement, it must be adjusted to the EU standards, directives, and best practices.
1.3. Objectives of the Study and Methodology
1.3.1. Objectives of the Needs Assessment Study
The overall objectives of this study are to support Georgia’s global competitiveness by strengthening the quality and safety of domestic products and services and by achieving greater trade integration with the EU through decreased TBT. The study consists of an assessment of current and future demand for QI services, tied to EU integration
25
negotiations, Georgia’s economic competitiveness priorities, and the current state of public national QI institutions. The study provides the following:
Outline of outstanding institutional and legal reforms required to harmonize the national QI with EU norms.
Identification of gaps in the technical capacity of the QI with respect to the requirements of the EU DCFTA and the support to export competitiveness.
Provision of recommendations for policy, particularly the implementation of the TBT strategy approved by the European Commission, and for investment priorities.
Since 2004–05, when the last study on the situation and future needs of the QI in Georgia was realized (PTB and GeoSTM 2005), some important changes in the institutional, economic, and social situation were implemented:
Subsequent reforms established a free and liberal economy with a high degree of liberty for interested national and international investors.
The physical infrastructure of the country, especially the roads, was improved, and plans for stabilizing the energy situation will be implemented shortly.
Until 2008, the country’s economic growth showed that the reforms opened the way to a certain economic recuperation. Although exports were not an engine of economic growth, some sectors like wine demonstrated more success in European markets. It is now clearer what may be the potential economic export sectors (IFC 2009).
The dissolution of the old Soviet-era Sakstandart and the foundation of the Georgian National Agency for Standards, Technical Regulations, and Metrology (GeoSTM) and Georgian Accreditation Center (GAC) in 2004 have significantly changed the institutional framework of Georgia’s QI, and both institutions began to seek more harmonization with international requirements.
The conflict with the Russia Federation in 2008 led to a new situation in Georgia’s commercial relations: the Russian market, as one of Georgia’s main markets, became less accessible because of the Russian embargo. The result is that the Georgian market has become more oriented to the EU and Asian markets, where international standards and rules defined by the World Trade Organization and other international organizations dominate. The market of countries of the Commonwealth of Independent States (CIS) with its set of “GOST” NQI rules is losing importance. Georgia decided to leave the CIS and its EuroAsian Interstate Council for Standardization, Metrology, and Certification (EASC).
The inclusion of Georgia in the New European Partnership and the Eastern Partnership (EaP) and the potential DCFTA with the EU require a harmonization with the legislative and regulatory framework of the EU, which is regulated by the EU’s “Global Approach” and “New Approach” Directives.
26
All the deep changes of the past few years require an updating of the study, which was finished five years ago. The objectives of such a new analysis include the following:
Analyzing the current situation of the QI using the existing materials of the Georgian government, the different donors, and consulting firms and realizing a new and more comprehensive demand study.
Defining the existing gaps, especially in metrology, standardization, accreditation, and conformity assessment.
Providing conclusions and recommendations to help the Georgian government to refine its TBT Strategy and the international donor organizations to focus their activities on the most urgent changes needed.
1.3.2. Methodology of the Study
The study was undertaken in Georgia between December 2009 and June 2010. At the center of the study was a survey of than 117 enterprises and 77 laboratories to assess the situation of the NMI (GeoSTM) and the NAB (GAC).6 The assessment was conducted through the following four steps: (1) Assessment of stakeholder demand: Define both the current and the future demand
of the main clients of the QI, taking into account a prospective DCFTA with the EU and requirements for global competitiveness (enterprises, state regulatory agencies, consumers, and nongovernmental organizations). The main instrument was a survey of the most important stakeholders. In contrast with the last survey, all the accredited laboratories and a broader number of enterprises were included, with emphasis on those sectors that are potentially competitive in international markets.
(2) Assessments of gaps: Assess the capacity of the QI institutions to carry out their mandates in view of domestic needs and international requirements.
(3) Upgrading of priorities and options: Explain priorities and discuss alternatives for technical and institutional upgrading of the national QI institutions for the development of a demand-oriented basic QI that responds to domestic needs and international requirements over the next 5 to 10 years.
(4) Recommendations: Provide detailed recommendations on institutional reforms, capacity building, and infrastructure investments based on the forthcoming QI roadmap agreed upon by the Ministry of Economy and Sustainable Development, and propose activities for international cooperation.
6 This survey was completed with documentation developed by PTB experts. The analysis of the current
situation of the other components of the NQI (standardization, accreditation, certification, testing, and technical regulations) is partially based on the expertise of PTB and the TACIS project and was completed with its own findings. An international expert was contracted to assess standardization and technical regulations. At the same time, findings were compared with the defined export potential, the foreseeable economic development trends in Georgia, and the international development trends in QI.
27
The study was supported by PTB (Braunschweig and Berlin) and is partially based on materials and recommendations developed by the EU TACIS Project and the PTB–GeoSTM/GAC project.
2. The Demand for Quality Infrastructure Services in Georgia
In February and March 2010, within the framework a study was conducted of the challenges faced by enterprises and laboratories with regard to quality infrastructure (QI) services available and practiced in the country. The basis of the study was a survey of 117 companies and 77 in-house and independent testing and calibration laboratories. Most of the surveyed companies and laboratories were visited and interviewed on the basis of two questionnaires (see Appendix A). The study covered every region of the country with important economic activities and where demand for QI services could be expected: Batumi, Gori, Gurjaani, Kaspi, Khelvachauri, Kobuleti, Kutaisi, Mtskheta, Ozurgeti, Rustavi, Signagi, Tbilisi, Telavi, Tskaltubo, and Zestaponi. 7
2.1. Assessment of the Results of the Laboratory Survey
2.1.1. Survey Methodology
The survey included laboratories operating in various fields (such as verification, calibration, and testing), including accredited, nonaccredited, commercial, and company in-house laboratories. The scope of the activities of the surveyed laboratories is shown in. The majority of the laboratories interviewed were testing laboratories (77 percent) Figure 4. The difference between verification and calibration8 is not clear in Georgia; hence, the percentages given for those tasks in Figure 4 reflect what the laboratories indicated, not necessarily what they actually do.
7 A background report, “Analysis of the Situation of the National Metrology System and the Demand for
Quality Services in the Market” provides more detailed results of the survrey. 8 The main difference is that verification defines measurement accuracy within fixed tolerances, whereas
calibration defines the measurement uncertainty.
28
Figure 4: Scope of Activities of the Laboratories in the Survey
The largest share of surveyed accredited laboratories was in Tbilisi (76 percent). The second location where such laboratories are situated is Batumi (11 percent). The survey methodology involved conducting direct interviews at the visited laboratories and obtaining required information electronically. The main customers of the accredited commercial laboratories that were surveyed are presented in Figure 5. Many of them work in testing and processing of agricultural products (12) and in the food and beverage sector (12), followed by the metallurgy sector (8), the energy production sector (7), and the retail market (7). Appendix B provides more details on the surveyed laboratories.
2.1.2. Certification and Accreditation of Management Systems
At present, the majority of accredited laboratories in Georgia are accredited by GAC in accordance with the outdated European EN 45001:2006 standard requirements. Only four were accredited according to the current internationally-recognized ISO/IEC 17025 standard. In general, the laboratories are aware of GAC’s intention to start the gradual shift of accreditations to the ISO/IEC 17025 standard. Only one of the visited laboratories (GM Pharmaceuticals in-house lab) has been accredited in accordance with ISO/IEC 17025 requirements. The laboratories realize the need for consulting assistance and training programs when starting to develop a relevant ISO-based management system and expect to receive this support from GAC. They are not aware that GAC cannot provide consulting and training assistance because of a conflict of interests and impartiality, so this support must be provided by specialized consulting and training firms. Thirty-eight percent of the accredited laboratories (16) stated that they received consulting services from GAC in preparation for accreditation. This situation clearly contradicts the principles of conflict of interests and impartiality of the accreditation process. This area could be a business opportunity for specialized consulting firms in the
verification8%
calibration10%
testing77%
others5%
29
future. Sixty-two percent of certified companies developed their management systems using their own human resources. The majority of the laboratories have a positive assessment of the accreditation process in terms of timing and GAC personnel qualification (see Figure 5).
Figure 5: Assessment of Accreditation Process in Surveyed Laboratories
Because laboratory accreditation is not required by law for performing testing services, the majority of the interviewed laboratories were motivated by customers’ requirements to undergo accreditation. Several companies, such as cellular network providers, a natural gas distribution company, and a subway transportation company, applied for accreditation of their laboratories, to gain their clients’ confidence. Certification becomes especially important because of the lack of official state supervision in this field. However, five laboratories (12 percent), from the oil and gas sector, believe that accreditation does not add substantial value to their operations and that the cost for this service is not justified. Fifty-six percent of accredited laboratories (22) do not acknowledge the positive effect of accreditation on their contracts and income. Referring to a possible increase in the technical competence of laboratory personnel because of accreditation, only 54 percent of accredited laboratories responded positively. Although accredited, some of these laboratories do not have adequate infrastructure conditions, which is not in accordance with EN 45001. The improvement of environmental conditions (such as temperature and humidity control, interior renovation, and so forth) was named as one of the main difficulties when preparing for accreditation. In general, one-fourth of all surveyed laboratories cannot ensure adequate environmental conditions required for accurate laboratory testing, including conditions in laboratories for testing food, verifying electrical appliances, and
0
5
10
15
20
25
Excel. Good Reg. Indiff. Excel. Good Reg. Indiff.
Time Competence of personnel
nu
mb
er
of
resp
on
de
nts
30
performing chemical testing. Unstable power supply was not mentioned as a problem by the laboratories; those who need a constant electricity supply have their own generators. Half of the interviewed laboratories state that accreditation has contributed to an increase in the number of their contracts and improvement in the competence of the laboratory personnel.
2.1.3. Assessment of Quality Management Systems
In addition to accreditation, 29 percent of accredited laboratories (12) also applied for certification of their quality management systems (QMSs) in accordance with ISO/IEC 9001 requirements. This has little value added since ISO/IEC 17025 accreditation includes the ISO 9001 assessment of the QMS but is common in former Soviet Union republics for two reasons: (a) in some cases the first step in introducing QMS was the certification according to ISO/IEC 9001 and (b) in some cases the laboratories simply did not know that ISO/IEC 17025 includes ISO 9001. As for the certification bodies in the local market, they are similar to those indicated for the processing companies below.
2.1.4. Services Received from Georgian National Agency for Standards, Technical Regulations, and Metrology
Accredited laboratories are required to ensure calibration and verification of their measuring instruments; they obtain these services from the Georgian National Agency for Standards, Technical Regulations, and Metrology (GeoSTM) and other calibration and verification laboratories. In general, the laboratories, like the processing companies, admit that the technical capacity and the level of personnel qualification need to be significantly improved at GeoSTM. During the interviews, a considerable number of laboratories stated that GeoSTM’s personnel issues verification certificates after having witnessed laboratory personnel calibrating measuring instruments using their own reference material. In these cases it was not clear that the “self-calibration” was undertaken with traceability to accredited laboratories outside the countries or not and if the traceability was guaranteed or not. This highlights that technicians from GeoSTM which are working in the laboratories and enterprises are not yet sufficiently prepared in modern metrology. To become competitive and effectively serve the metrological purposes of the sector, the laboratory representatives believe that the GEOSTM urgently needs the following:
Qualified personnel for verification and calibration for modern measurement instruments.
Technical ability to calibrate and verify modern measuring devices.
Relevant reference materials and standards.
Establishment of a measuring equipment service center.
Reevaluation of present price levels.
31
The survey revealed requirements for improving technical competences to calibrate the measuring equipment, including but not limited to the equipment found in Table 2.9
Table 2: Equipment Requiring Improvements in Calibration Competence Identified in the Survey
Massspectrometer
Atomic absorption spectrometer
Mechanical measurement devices
Reference dynamometers
High-resolution reference devices for measurement of alternating current
Geometrical measurements, verification of templates
Verification of high frequencies
Luxmeters
Humidity meters
Dose meters without contact system
Reference electrical meters (class 0.01 and class 0.2)
Hydrogen sulphide analyzer
Density meter
Viscosity meter
Chromatograph
Mechanical impurities detection device
Thermo camera
Reference coil
Pyrometer
Verification of G16-G1600 industrial gas meter stand and G1.6-G25 household gas meter stand
Modern earthing equipment
Gluten deformation measuring device
Detectors of chromatograph
Micrometers
Kilovoltmeters
9 In the interviews “calibration” is often mixed up with verification.
32
Infrared imager
Dielectric absorption sensor
Turbidimeter
The majority of nonaccredited laboratories do not acknowledge the need for calibration or verification of their equipment. Some of them were not even informed about the existence of GeoSTM or other calibration and verification laboratories. None of the milling companies have applied for calibration and verification services. Only 20 percent of laboratories mentioned that they participated in training offered by GEOSTM. However, all the interviewees admit the importance of such services and express the wish to be regularly informed about training programs in metrological issues. The companies also request the establishment of a hotline at GeoSTM and the dissemination of information regarding training and other issues in the metrological field.
2.1.5. Assessment of Laboratory Personnel
As for the reliability of the personnel’s knowledge, only approximately 10 percent of the interviewed accredited laboratories are aware of modern standards or testing methods. Not all laboratories apply or even know all the standardized testing methods. The consequence is that test results in Georgia are not comparable with test results in other countries. A second test outside the country is necessary if the products are to be exported. Generally, in all cases laboratory personnel need to receive regular training and updates on modern equipment, methodologies, best laboratory practices, ISO/IEC 17025 requirements, and so forth. In general, laboratories acknowledge the need for regular professional development for their personnel. In terms of age and salaries, the situation in most of the visited laboratories seems to be better than in the laboratories of the National Metrology Institute (NMI) within GeoSTM. Surveyed laboratories range from those who employ mostly older personnel who can work with older equipment to modern-equipped laboratories with younger and better trained specialists (see age distribution in Appendix B).
2.1.6. Main Problems for Competitiveness
One of the main problems for competitiveness stated by the majority of the commercial laboratories is related to their operation at less than full capacity. This issue was especially mentioned by the laboratories involved in food testing. At the moment, a certain overcapacity can be observed, a consequence not only of the breakdown of the Russian market and the economic crisis of 2008–09, but also of foreign support for establishing and improving laboratories without a consolidated market analysis.
33
The lack of reference material combined with the high cost of appropriate maintenance of modern laboratory equipment also create obstacles for effective and efficient laboratory operations. All laboratories (including those which were supported by international donors) pointed out that the capital investment cost is not considered in developing a pricing scheme for their services that would keep prices at reasonably affordable levels for customers. The lack of financial resources needed for regular upgrading of the laboratory technical base is admitted to be among the top challenges faced by the local laboratories. The lack of equipment service centers in the country was a particular problem for laboratories that have relatively modern measuring instruments. Laboratories are often forced to bring maintenance specialists from abroad because relevant technical expertise does not exist locally.
2.2. Assessment of the Results of the Enterprise Survey
2.2.1. Objectives and Methodology of the Survey
The study included 117 enterprises which either met with interviewers or sent electronic responses. Appendix B includes more details of the survey. The survey had several objectives:
Understand the role of quality in Georgian companies.
Provide an overall evaluation of management systems.
Identify general patterns and challenges faced by them in terms of quality infrastructure services.
The distribution of companies regarding market presence and sectors is presented in Table 3 and Table 4, respectively.
Table 3: Markets of Surveyed Enterprises
Company type Quantity
Wholly export-oriented companies 11
Companies with local presence only 71
Companies with local and international sales 33
34
Table 4: Sector Distribution of Companies That Were Visited or Responded Electronically
Sector Quantity Subsector Quantity
Food 58 Dairy 11
Meat 4
Alcoholic beverages 15
Nonalcoholic beverages 2
Mineral water 2
Cannery 5
Hazelnut 3
Flour mill 4
Bakery and pasta 4
Beekeeping 2
Tea processing 2
Primary agriculture 4
Nonfood 59 Pharmaceuticals 5
Chemicals 6
Packaging materials 2
Construction 3
Construction materials 6
Plastic 2
Wood processing and furniture 4
Energy (oil and gas) 14
Apparel 7
Aviation 2
Information technology 1
Mining 2
Drinking water 3
Transportation 1
Engineering 1
In addition to domestic firms, the survey also involved subsidiaries of multinational companies including Coca-Cola Bottlers of Georgia, Natakhtari Brewery, KazTransGas, BTM Textile, Adjara Textile, and so forth.
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2.2.2. Certification of Management Systems
The survey identified companies that have implemented management systems in accordance with international standards: ISO/IEC 9001: 2000/2008, ISO/IEC 22000:2005, and ISO/IEC 14001: 2004. ISO/IEC 9001 and ISO/IEC 22000 are more often applied in Georgian companies than is ISO/IEC 14001 or other international standards. Only two surveyed companies have introduced ISO/IEC 14001, and only one company in primary agriculture has incorporated the GLOBAL G.A.P. (Global Good Agricultural Practice) requirements. As evidenced from the survey, the majority of food companies have integrated food safety and QMSs. The same can be said about nonfood companies applying ISO 9001:2000/2008 and ISO 14001 requirements jointly. The Georgian market, as evidenced from the survey, is dominated by TÜV Nord, TÜV Süd, Bureau Veritas Certification, IQNet, and Russian Register certification bodies. Société Générale de Surveillance SA SGS, Certification International, Global Certification, IFTA (International Free Trade Agreement), and URS are also present at a smaller scale in the market.
2.2.3. Assessment of the Management Systems
Of the 117 companies, only 28 have certified management systems (Figure 6).10 The motivations of companies to introduce the management systems can be linked to (a) client requirements and new market penetration mainly with export-driven companies and (b) a willingness to improve competitiveness (competitors’ influence). The survey, conducted in June 2009 within the project “Improving Food Standards and Safety in Georgia,” undertaken by the Eurasia Partnership Foundation with the financial support of the U.S. Agency for International Development (USAID), revealed the incentives of companies to introduce food safety management systems (Figure 7).
10
The number denotes the management systems separately; however, some companies have integrated management systems of ISO 22000 and ISO 9001 or ISO 9001 and ISO 14001.
36
Figure 6: Number of Enterprises with Management System Certification in the Survey
Note: HACCP = Hazard Analysis and Critical Control Point. *HACCP principles are incorporated in ISO 22000.
Figure 7: Main Reasons for Implementing Food Safety Systems in Georgian Companies
Source: Survey conducted by GDCI in June 2009 in the framework of the project entitled “Improving Food Standards and Safety in Georgia” implemented with the support of Eurasia Partnership Fund and USAID.
0
5
10
15
20
25
30
ISO 9001 ISO 22000 HACCP* ISO 14000
37
Another 50 companies intend to integrate international management system requirements into their operations, while a number of companies reject the idea because of difficult financial circumstances or absence of client and legal requirements. Companies without international certification lack adequate knowledge and awareness of modern quality management practice requirements. Moreover, the needs for QMS and metrology training are not explicitly realized by the majority of companies. Few companies have separate quality management sections in their organizational structures, but they do have quality managers and QMS functions are distributed among various units of the firm. In some companies, the quality management section responsibilities are assumed by the laboratories undertaking quality control and assurance or other units with similar responsibilities. The cases of complex QMSs were also evidenced. Georgian companies can be classified as follows according to their management systems: (a) Certified companies that have integrated complete management systems (deep
commitment of management and employees is declared and evidenced).
(b) Certified companies in which omissions or violations make effectiveness of the systems questionable.
(c) Noncertified companies that understand the need for management systems but lack information, relevant skills, and, in some cases, financial resources.
(d) Noncertified companies that neither realize the need for nor are interested in incorporating modern quality principles. Surprisingly, some sectors demonstrated complete ignorance of the need for metrological services and accuracy measurements.
Obviously, the certified companies, having invested huge efforts in their quality systems, find themselves in an unfair situation with companies that have a formal system based on a “framed certificate” only.
2.2.4. Assessment of the Services Received by Companies
Metrology The perception of the importance of metrological services varies from company to company. Although some do not realize the benefits of metrological services, others undertake this activity on a regular basis. Unfair practices encountered in this field, like providing documents without verification or not undertaking in-depth inspection of relevant equipment, were also mentioned during the interviews. Not surprisingly, such incidents coupled with the lack of technical competence and qualified personnel cause many companies to be unwilling to cooperate.
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The interviews with the companies demonstrated that, in many cases, they do not distinguish between calibration and verification. In addition, the term uncertainty is often neither heard nor understood. Only 60 companies have used GeoSTM metrology services, and very few use the services of private independent calibration and verification laboratories. Furthermore, a certain number of companies admitted they were unaware of GeoSTM’s existence. The companies consider the metrology services provided by GeoSTM as either “satisfied” or “regular” with few cases assessed as “unsatisfied” or “excellent” (Figure 8). It was apparent that many companies overestimated the quality of the NMI services. Several companies that evaluated the services as “satisfied” mentioned that the working conditions of GeoSTM casted doubt on the reliability of its activities. The majority of respondents pointed to inordinately expensive prices charged by GeoSTM for its services.
Figure 8: Evaluation of the NMI's Services: Number of Respondents in the Survey
Overall, companies identified the following issues with GeoSTM and its metrology services that pose difficulties to private companies:
Limited number of services provided.
Lack of appropriately equipped technical facilities, including unavailability of reference materials.
Lack of qualified personnel.
Lack of knowledge about modern measurement devices.
Inadequate technical capability of regional services (for example, Batumi and Rustavi).
Lack of information about GeoSTM’s services, metrology, measurement instruments, and so forth.
0
5
10
15
20
25
30
Excellent Satisfied Regular Unsatisfied
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Standardization The National and EASC standards11 are most widely used by Georgian companies. The availability and accessibility of updated GOST standards in a few companies were questionable. Some companies, though willing to apply specific ISO/IEC or other EU or internationally recognized standards, refrain from undertaking this step because of the poor translation quality in Georgia, which may create further obstacles for users in the application process.12 The companies purchase the standards through GeoSTM, the Internet, or other sources. Moreover, only one enterprise could confirm that they were a member of a GeoSTM technical committee. In summary, the improvements are required in the following directions:
Maintain updated standards base.
Develop national standards harmonized with international standards.
Ensure the accurate translation of international standards.
Streamline accessibility to information.
Provide updated news of the field.
Laboratories Almost all companies using local laboratory services evaluate the services as either “excellent” or “satisfied.” One company encountered difficulties in finding any Georgian laboratory that could determine pesticide maximum residue levels and, therefore, was forced to send the sample abroad. Chambers of Commerce and Business Associations The benefits of membership in chambers of commerce and business associations are not fully appreciated because quality-related services are rarely covered by them..
2.2.5. Main Problems for Competitiveness
The companies are not subject to any type of state inspection, no matter in which sector they are involved. Regarding obstacles to competitiveness, the companies identified issues including, but not limited to, the following:
Improvement of legislation in some sectors (for example, pharmaceuticals) or the need to enforce laws (for example, law on food safety and quality).
11
Euro-Asian Interstate Council for Standardization, Metrology, and Certification. This is the CIS successor organization of Gosstandart. 12
With the translation of the ISO/IEC series 17000 now approved by the Academy of Georgian Language, the situation will gradually improve.
40
Need for Georgian legislation to be coordinated with international requirements.
Need for introducing government inspections in fields like construction and food.
Absence of proper metrology services, with traceability being the biggest obstacle.
Absence of ISO 17025–accredited laboratories.
Outdated prices for equipment and needs for their upgrade.
Lack of qualified personnel in technical and scientific fields (for example, maintenance and agronomy), including metrological sphere linked with low salary levels.
Low level of higher education institutions.
Absence of updated national standards in certain fields.
Absence of standard requirements for ensuring the production of identical products by all producers.
Competition with cheap, low-quality imported products.
Improperly organized tenders with least-cost selection procedures that attach secondary importance to the quality of goods and services.
Bureaucracy linked with the registration process in CIS countries (for example, pharmaceuticals).
Impediments to access to finance rooted to financial crises and high interest rates of banks; financial difficulties that are also revealed in decreased sales.
Lack of subsidies and sequential, interrelated activities of government for promoting Georgian wine in international markets.
Programs to support small businesses and protect domestic companies from competitors.
Unorganized trade and unfair competition.
Poor and unreliable supplier base (for example, raw materials, animal health issues, and packaging materials).
Poor logistics infrastructure (for example, greens export in EU).
2.3. Recommendations
The results of the survey suggest the following recommendations for improving quality in Georgia. Promoting Quality Awareness in the Market
Promoting the importance of international management standards.
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Strengthening the functions of chambers of commerce and business associations in quality matters.
Organizing awareness seminars for enterprises, laboratories, and public regulatory agencies in the field of QI.
Strengthening the Capacity for Quality Upgrading in the Market
Accrediting laboratories in accordance with ISO/IEC 17025 requirements and directing efforts toward eliminating problems in this area, including training and consulting offered by GAC to all interested parties.
Promoting the establishment of (private) equipment service centers, in addition to calibration and verification services, in Tbilisi and in the regions.
Increasing the qualification of personnel through training sessions and internships.
Planning activities aimed at attracting young English-speaking technicians so that the existing knowledge and experience is transferred and the future of the QI services is guaranteed.
Providing a series of training sessions to private companies in QMS, metrology, standardization, accreditation, and testing.
Improving GeoSTM Services
Upgrading facilities and technical competence of GeoSTM, including the strengthening of regional offices.
Reviewing the tariffs developed by GeoSTM for metrological and standardization services and creating a consistent marketing strategy.
Creating more user-friendly websites for GeoSTM and GAC with ongoing updates to streamline the access to standards.
Creating a group of technical experts to make authentic translations, with the existing translation of the ISO/IEC series 17000 as a base.
Actively involving company representatives in the technical committees of GeoSTM as the national standardization body.
Introducing better search engines (for example, GeoSTM website) and online download services.
Establishing a hotline at GeoSTM and disseminating information on metrological news among the client companies and subscribers.
Improving the Legal Framework
Focusing on establishing regulatory requirements for technical regulations and legal metrology in the country.
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3. The Current Legal and Institutional Framework
3.1. The Current Legislation
The current legal and institutional framework of Georgia’s NQI was essentially established by the reform processes in 2004–05. The national standardization system is regulated by the following legal acts:
Constitution of Georgia
Law on the Provision of the Uniformity of Measurements, 1999 (with amendments and supplements made in June 2005)
Law on Standardization, 1999 (with the amendments and supplements made in June 2005)
Law on Legal Entities of Public Law
Order N1-1/1057 of the Ministry of Economic Development of Georgia, October 7, 2005, “On Approving Charter of the Legal Entity of the Public Law—National Agency for Standards, Technical Regulations and Metrology.”
Governmental decision concerning the implementation of the World Trade Organization (WTO) Code of Good Practice for the Preparation, Adoption and Application of Standards for National Standardization Bodies (NSBs), which involves the establishment and functioning of the WTO’s Agreement on Technical Barriers to Trade (TBT) inquiry point and the responsibility for the provision of answers and documentation to all reasonable questions from interested parties and acts as a National Notification Authority (NNA), pending approval.
Law on Certification of Products and Services
Binding acts, known as “Regulations of Georgian National Accreditation Center,” of which the most important are the following:
Accreditation rules and procedures: GAC 1.1:2006 Regulation on Accreditation Center Council: GAC 1.6:2006 Status of GAC and its organizational structure.
The reforms of 2005 were an important step in the direction of international harmonization, but in many aspects, they were not formulated in accordance with international practices and requirements. For this reason, the Georgian government has initiated a reformulation of all the laws that refer to the NQI. The intention is to pass a quality code that redefines the whole system.
3.2. The Current Institutional Framework
At the time of the study, the NQI had a very clear vertical structure (Figure 9). At the top was the Ministry of Economy and Sustainable Development (MoED), and a deputy minister is responsible for the NQI. The Department of Economic Analysis and Policy assists the deputy minister and serves as a technical secretariat for this work. GeoSTM
44
and GAC, as the main institutions of this structure, are subordinate to MoED as independent, public, nonprofit organizations, and the deputy minister acts as trustee of the two institutions. GeoSTM has two directorates, one for metrology (the National Metrology Institute, or NMI) and one for standardization (NSB). It is unclear why the NMI and the NSB were not created as separate institutions, as is usual in most countries. GAC was instructed to build up the national accreditation body (NAB). With the establishment of these two bodies, a radical cut was made, but unfortunately not enough young English-speaking people were engaged. Figure 9: Core Institutions of Georgia’s National Quality Infrastructure
By Decree 1-1/2347 on October 19, 2009, a Quality Council was founded, acting as an advisory board to the Ministry of Economy and Sustainable Development13 for developing the NQI. The Council is composed of representatives of the main public (ministries and state regulatory agencies) and private stakeholders of the NQI (entrepreneurs, entrepreneurial associations, laboratories, consumer and environmental protection nongovernmental organizations (NGOs), and academia). The Council is the first step toward coordinating the interests and activities in the NQI on a horizontal level and including the private sector, but it still lacks clear objectives, tasks, responsibilities, and agenda (see Appendix C for the decree and members). Because of the Council’s broad responsibilities, it could be more efficient to link the Council to the prime minister
13
Formerly called the Ministry of Economic Development
45
and to transfer some of the responsibilities to the Ministry of Economy and Sustainable Development. The development and implementation of the TBT and SPS strategies is coordinated by the Prime Minister’s Advisory Board. The board is an important state actor in the field.
3.3. State Promotion of NQI Activities
In Georgia, support for the quality assurance is mainly left to the private sector. Although in highly industrialized economies there are well-developed markets for quality, low and middle income countries typically face many market imperfections, including lack of information, lack of technical knowhow. In many countries governments help foster quality assurance in the private sector through instruments such as awareness seminars and matching grants for enterprises and laboratories to improve their quality systems (Box 1). In many countries the governments use accreditation and certification as part of market surveillance (for instance the European Commission). The Georgian government has recently supported many activities in the area of awareness building; the Quality Council could be a very useful instrument in this direction.
Box 1: CORFO’s Quality and Productivity Program in Chile
In 2005–07, Chile’s state financing corporation, the Chilean Economic Development Agency
(CORFO) developed a quality program for small and medium enterprises (SMEs) called
“Calidad y Productividad” that supported the certification of quality management systems
(QMSs) by ISO/IEC 9001 and ISO/IEC 14000. The interested enterprises were required to
present proposals, and CORFO co-financed up to 50 percent of the costs of the certification
process. Through this program, not only were more than 1,000 SMEs successfully certified,
but awareness of quality issues among Chilean SMEs also increased. Many enterprises had
economic benefits from this program: lowering costs, maintaining their client base and
gaining new clients, and better satisfying their collaborators. In many cases, the critical
issue in industrial plants was the lack of traceability of the measurement devices.
3.4. Entrepreneurial Associations and NQI
Currently, entrepreneurial associations and chambers of commerce have become more aware of quality problems, but concrete solutions are scarce. Only two institutions, the Georgian Employers’ Association and the Association of Oil Product Importers and Distributors, participate in quality assurance activities, and both are members of the Quality Council.
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3.5. NGO Activities in the Field of Consumer Protection
Consumer protection is still a weak area for many Georgian companies and NGOs. The most active NGO in this field is the Consumer Federation of Georgia, which collects consumer complaints and also tests products. There are also one or two other organizations. In general, however, the market in Georgia is primarily price-oriented and not quality oriented. Consumers are not accustomed to being critical of low-quality products and to report problems. Nor are quality problems a common theme in mass media; qualified journalists are missing, and the government is not very active in this area.
3.6. Recommendations
The new legislation only partially corresponds to international requirements as far as best practices and hinders the establishment of an efficient system of calibration and dissemination of internationally recognized traceability standards. The proposed quality code will adapt the legislation to international standards, particularly European rules, but advice from European experts in this field is strongly recommended.
The NQI has a clear vertical structure: At the head is the MoED. GeoSTM and GAC, as the main institutions of this structure, are subordinate to the MoED as independent public nonprofit organizations. The Quality Council founded in October 2009 is the first step in coordinating the interests and activities in the NQI on a horizontal level and in including the private sector, but clear objectives, tasks, responsibilities, and agenda are still lacking. It may be more efficient to link the council to the Prime Minister and to transfer some responsibilities for its work to the Ministry of Economy and Sustainable Development.
As a result of the reforms of 2004–05, GeoSTM was created with a National Standardization Body and a National Metrology Institute. Unfortunately, standardization and metrology were not separated into independent institutions as is the case in most countries. Moreover, within the NMI, there is no clear administrative separation between scientific and applied metrology, industrial metrology (calibration services for industry), and legal metrology.
Currently, no state activities promote quality in enterprises except a few awareness seminars with international donors. The government should consider fostering quality assurance in the private sector through matching grants for enterprises and laboratories to improve their quality systems.
With two exceptions, chambers of industry and of commerce and business associations are not very active in quality issues. Increasing their awareness of its importance and offering related activities would contribute to improving competitiveness, in particular that of Georgian SMEs.
Consumer protection is also a weak point. Some improvement can be expected with the new amendment of the law on measurement instruments that are subject to legal metrology and the newly instituted inspections on food safety in
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2011. Consumer protection NGOs can be strengthened, and mass media can actively report on these issues.
4. The Components of the National Quality Infrastructure
4.1. The Georgian National Agency for Standards, Technical Regulations, and Metrology
4.1.1. Institutional Structure
The Georgian National Agency for Standards, Technical Regulations, and Metrology (GeoSTM) resulted from the reforms of 2004–05 when the post-Soviet Sakstandarti was dissolved and a new structure was founded, consisting of:
GeoSTM with a general director and two directorates
the National Standardization Body (NSB)
the National Metrology Institute (NMI)
The Georgian Accreditation Center (GAC) as the national accreditation body.
Standardization and metrology were not separated in spite national and international advice. However, management was strictly separated. Since the reforms, the development of standards and metrology in Georgia has been a slow process of building up a demand-oriented metrological base. According to GeoSTM’s organigram, GeoSTM consists of five units:
(1) Administration, including the office of the general director
(2) Department of Standards and Technical Regulations
(3) NMI
(4) Department for Verification and Testing
(5) Regional offices (Batumi, Gori, Kutaisi, Poti, Rustavi, Telavi, and Zugdidi)
With exception of the director of the Department of Standardization and Technical Regulations, the responsibilities of the directors under the general director are unclear. Both the director and the deputy director14 of the NMI appear to have responsibilities for legal metrology.
14
Because the study took place over a long period of time and some recommendations were immediately implemented, some findings are no longer valid. Thus, the function of the deputy director was eliminated in July 2010.
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GeoSTM receives 230,000 Lari15 from the state budget for paying the budget staff. The rest is financed by services (calibration, verification, consulting, and so forth). The salaries are very low, such that the staff members who are financed by the budget receive additional income depending on the results of their work. The small amount of financing explains the relatively high number of staff not financed by the budget.
4.1.2. International Recognition
The NMI’s highest priority is achieving international recognition, through accreditation by either an internationally accepted accreditation body or an independent peer review of the technical capabilities. The process includes the following milestones:
Availability of traceable standards and equipment according to metrological needs, which serve as national measurement standards.
Specifically qualified and competent laboratory personnel.
Implemented and validated calibration and verification procedures.
Implemented quality management system (QMS) according to international requirements (International Organization for Standardization/International Electrotechnical Commission [ISO/IEC] 17025 general requirements for the competence of testing and calibration laboratories).
Signatory of the Meter Convention or Associate Membership in the General Conference of Weights and Measures (CGPM).
Successful participation in key interlaboratory comparisons whose results—the calibration and measurement capabilities (CMC) of the NMI laboratory—are published in the key comparison database of the International Bureau of Weights and Measures (Bureau International des Poids et Mesures, or BIPM).
Once these steps have been successfully accomplished, the NMI will be in the position to sign the CIPM-MRA (Mutual Recognition Arrangement of the Comité International de Poids et Mesures). This international arrangement among NMIs was established to enable the mutual recognition of national measurement standards and of calibration and measurement certificates issued by the NMIs. Georgia has completed the first steps: Since 2008 it is an Associate of the CGPM, and in 2010, the first two NMI laboratories that follow international requirements were founded. Although the first attempts at bilateral interlaboratory comparisons may now be obtained, much remains to be done. If the QMS according to ISO/IEC 17025 will be consequently implemented on the level of the NMI within GeoSTM and on the level of the respective laboratories (mass, physical-chemical analysis, electrical magnitudes, and temperature), international recognition for the first laboratories could be obtained in the next two to four years. But this recognition requires some other important changes, which are described below.
15
Approximately USD 108.000
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4.1.3. Scientific and Applied, Industrial, and Legal Metrology in Georgia
In most countries, metrology is separated into three categories (see Figure 10):
Scientific and applied metrology: provides the highest level of metrology (on a level fit for addressing the country’s needs). It develops and maintains the national measurement standards, ensures the traceability of the measurements to the international system of units (SI), and provides traceability for industrial and legal metrology.
Industrial metrology: provides traceability to measurement instruments used by industry for calibration.
Legal metrology: ensures adequate consumer protection by verification of measuring instruments used for commercial transactions in trade, health care and safety.
Figure 10: Traceability Chain of Scientific, Industrial, and Legal Metrology
NMI
Calibration
Laboratory
Verification
Laboratory/Office
Industrial
MetrologyLegal
Metrology
Yes
Certificateofe Calibration:
• Traceabilityto the SI units
• Measurement Value
• Measurement Uncertainty
Certificate of Verification:
• Yes
or
• No
Verification for consumerprotection
Quality System
ISO Standards
9000, 17025.
ISO Guide 65, etc.
Technical
Regulations
Certificate of
calibration
Certificate of
calibration
Scientific
Metrology
Source: PTB presentations.
Industrial and legal metrology depend on scientific and applied metrology, which assure the traceability of the measurements and, thus, their reliability and comparability. At present, the traceability chain to other NMIs is not ensured. The new laboratories installed with the help of donor projects have traceability for mass (Germany’s Physikalisch-Technische Bundesanstalt) and some physical-chemical magnitudes (the Czech Republic’s NMI for pH and electrical conductivity). Traceability also exists partially in the field of temperature. The dissemination of calibration services within the country
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does not exist because the method is only theoretically known. With the elimination of mandatory verification of all measurement instruments, only a few enterprises asked for calibration or allowed their instruments to be verified to ensure the accuracy of their measurements. During the study, the metrological services in Georgia were transitional: the old methods are no longer applied, and the new ones are being introduced gradually. Legal metrology practically disappeared after 2005 although the metrological method used is still verification (that is, the definition of tolerances, not of uncertainties). Verification is undertaken by the respective laboratories of the NMI within GeoSTM and its regional offices. With an amendment to the existing “Law on the Provision of the Uniformity of Measurements” at the end of 2009, a list of measurement instruments was published, which will be subject to legal metrology (Table 5).
Table 5: Measurement Instruments That Are Subject to Legal Metrology
Measurement instrument Intervals
Alcohol meters for breath analysis 6 months
Water meters
Cold water meters 6 years
Hot water meters 4 years
Cold and hot water meters 6 years
Automatic scales 18 months
Nonautomatic weighing instruments and scales 18 months
Flow measuring instruments for liquids other than water 1 year
Flow measuring instruments for counter and metering mechanisms for dispensers at pump stations (mechanisms that are used for gases)
1 year
Gas meters
with maximum flow of Qmax ≤ 10m3/hour 10 years
with maximum flow of Qmax > 10m3/hour 4 years
Liquid level meters in vessels 2 years
Noise meters 10 months
Speedometers 1 years
Electrical energy meters/kWh meters 12 years
Source: GeoSTM. Note: m
3 = cubic meter.
The list is small. But in some cases (for example, flow meters and noise meters), traceability cannot yet be ensured by GeoSTM.
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4.1.4. Building and Equipment Conditions
The NMI building is in very poor condition, and in particular, the environmental and power supply problems are in critical condition for most metrological activities. Maintaining the temperature and humidity, especially during the winter and because of high ceilings, is a problem. Conditioning and heating such a large building is a major cost factor. Calibration processes are not under control, results are not reproducible, and constant change in temperature and humidity levels affects the performance of standards and measuring instruments. Another big problem is the power supply. Because the current transmission line (6 kilovolts) and the supply category of GeoSTM (category 3 which is the lowest one) do not ensure a stable energy supply, the new mass laboratory was temporarily closed with no foreseeable problems for the accuracy of measurement. The new laboratory for physical-chemical analyses was not connected until now for the same reason. A stable power supply is needed for the whole building. It is also indispensable for the chemistry laboratory, the electrical laboratory, and others. Three alternatives exist for solving the building and equipment problems:
(1) Construction of a new building designed from the ground up to meet the technical requirements of an NMI. The requirements include (a) location in an area that offers good environmental conditions (sufficiently little vibration, no dust, no electro-magnetic interference, non-interrupted power supply, sufficient illumination, etc.), (b) ensured property rights, (c) adequate results of the required environmental impact studies; and (d) permission from the International Atomic Energy Agency (IAEA) to shift the ionizing radiation laboratory to the new location.
(2) Reconstruction of another, more adequate building that is already owned by the state. The requirements include (a) good environmental conditions of the building and the surroundings and (b) permission from IAEA to shift the ionizing radiation laboratory to the new location.
(3) Reconstruction of the existing building. The requirements include (a) a decision about what to do with the three unnecessary floors and (b) efficient improvement of the environmental and working conditions in the used rooms. The costs of reconstruction are probably higher than the costs of construction of a new building, but there are fewer bureaucratic obstacles.
A decision must be made rapidly so that the costs of transferring the laboratories to a new building are not raised substantially. During the study, the part of the NMI that is considered the core comprised 11 units ( Box 2) with 45 employees, of which 34 are financed by the state budget and the remaining 11 employees are financed by the income generated by GeoSTM’s services (see Appendix D for staff structure). One of the electricity laboratory employees works half-time in the NMI and half-time in a private measurement laboratory. In the employee figures, the support personnel (security, cleaning, and so forth) are not
52
included, and the accounting division is part of the general directorate. The reduced number of employees is the result of changes. After layoffs over the past five years, the current NMI administration is trying to optimize the size of the institution.
Box 2: The Condition of the “Core” Laboratories in GeoSTM/NMI
The two upgraded, newly installed laboratories for mass and physical-chemical measurements have appropriate modern equipment with traceability to well-situated European NMIs. The personnel are in the process of being trained, and services for industry, trade, and society have already been offered in 2010.
The temperature laboratory (part of the mechanical magnitudes laboratory) is being upgraded, financed by GeoSTM.
The veteran electricity laboratory has old Soviet and (East) German equipment and very few new instruments, but they are in good condition and will require only a minimum of calibration or verification services. This laboratory will be modernized next.
The radiation laboratory was supported by IAEA and is serving as a secondary standard dosimetry laboratory for calibrating and verifying instruments and dosimeters used in radiation protection and environmental radiation measurements. Its third and final upgrade phase is not yet underway.
All the other laboratories have old equipment from the Soviet era with which they try to do their best.
GeoSTM has six measurement laboratories that are considered the scientific and applied metrology portion of NMI (table V.2); the new mass laboratory will be the seventh. The laboratories in Batumi and Kolkheti are in the process of liquidation.
4.1.5. Structure, Qualification, and Age of Staff
NMI staff have a very high qualification level (see Appendix D). Approximately 30 percent of the personnel are candidates for or have a doctor of science degree (according to the Soviet and post-Soviet systems).16 In contrast to the high qualification level, the age structure is alarming (Table 6). More than half of the staff is more than 60 years old, and some of the most qualified laboratory heads are more than 70 years old. The practical absence of experts between 30 and 50 years of age (approximately 20 percent of the staff) is a legacy problem that must be overcome rapidly.
16
The Soviet and post-Soviet systems have a “candidate of science” degree, which is more or less equal to a PhD in the United States or Canada. The doctor’s degree is a higher-level degree.
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Table 6: Age Structure of the NMI Staff, June 1, 2010)
Age of staff
Number of staff
Financed by state budget
Financed by laboratory
income
Total
Percentage
< 30 years 1 3 4 7.3
30–40 years 2 1 3 5.5
40–50 years 6 2 8 14.5
50–60 years 8 4 12 21.8
> 60 years 26 2 28 50.9
Total 43 12 55 100.0
Source: GeoSTM
4.1.6. Recommendations
In the future, the NMI needs a clear administrative separation of the work of scientific and applied metrology, calibration services (industrial metrology), and legal metrology. The organizational structure of the services (calibration, consulting, training, and information) must be reconsidered. A stronger marketing orientation should be implemented in both the administration and the laboratories. It is not clear what “household provision service” means. If this division is responsible for buying and selling products and services for GeoSTM, it is not correctly positioned within GeoSTM’s structure.
The structure and position of legal metrology within the NMI must be defined. At the moment, the legal service fulfills the task of controlling the measurement instruments, which are the objective of legal metrology.17 The regional laboratories accomplish the functions of legal metrology (verification) and industrial metrology (calibration). A solution could be to unite them into a new legal metrology department.
Some of the surveyed enterprises discussed the poor quality of the metrological services in the regions. GeoSTM must ensure the adequate supervision and control of the regional branches. Privatization of some of the regional GeoSTM laboratories should be considered.
The survey of 117 companies in a wide spectrum of economic branches and services and 77 independent and in-house laboratories resulted in an unsatisfied demand for calibration and verification, particularly in the following fields:
17
The activities of the legalization service are type approval of legal measuring instruments, maintenance of legal measuring instruments’ type, and recognition of initial verification results.
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Physical-chemical measurements, regardless of economic branch: aircraft, food manufacturing, gas and oil transportation, food and environment safety—absence of reference materials and certified reference materials (CRM).
Lack of facilities and controls (specific reference materials) for calibration of modern measuring instruments: mass spectrometers, carbon-dioxide analyzers, moisture meters, hydrogen sulfide analyzers, viscosimeters, high resolution chromatographs, and so forth.
Clinical diagnostics: lack of capabilities for verification (in the legal sphere) on immuno-ferment analyzers, biochemical analyzers, ion-selective analyzers, and blood analyzers.
Measurement for testing in construction and plastic tube manufacturing: calibration of force compression and break machines, reference dynamometers, specialized measurement and test equipment for testing banding hydrostatic pressure, combined testing force plus temperature, ultra sound defectoscopes, and geodesic devices.
Transport: tachometers and rail meter carriages.
Gas supply: calibration of reference sets for calibration of industrial gas flow meters G16-G1600 and household meters G1,6-G25.
Almost all fields of testing: traceable calibration of spectral and roentgen-structural analyses.
Dosimetry testing: calibration (verification) of noncontact dose meters and digital humidity meters.
Although the first steps of the modernization process are complete, deep problems must be resolved if Georgia wants an NMI that can satisfy the basic needs of its economy and society and that meets international rules and European standards. The most important problems are the following:
The staff is aging. The vast majority, about 51 percent, are more than 50 years of age. Not only young staff, but also more experienced metrologists are missing who could replace laboratory heads in the future.
In most laboratories, the equipment is obsolete and lacks traceability. Even simple devices like balances and manometers must be sent abroad for calibration, thereby tripling expenditures for calibration because of transportation costs and custom fees.
The NMI’s building is in poor condition and too large. The environmental conditions (particularly climate control) are unsuitable.
For a long period of time, Georgian metrology institutions had no contact with international metrological organizations. GeoSTM joined the regional metrology organization, the Euro-Asian Cooperation of National Metrological Institutions (COOMET) only in 2006. In 2008, it became an associated member of the international metrology institution, BIPM. It is not a member of the International
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Organization for Legal Metrology (OIML), which is important for the development of the legal and institutional framework of metrology.
GeoSTM’s link with potential customers and stakeholders (ministries other than MoED, enterprises, and laboratories) is rather weak. This deficiency makes setting investment priorities and handling complaints difficult. The formation of an advisory board representing the national quality infrastructure (NQI) stakeholders, including GAC and NSB, would be very helpful.
The development of a QMS in conformity with the latest international laboratory standards ISO/IEC 17025:2005 and ISO Guide 34:2000, which is important for the international recognition of GeoSTM´s measurement capabilities, is only in its initial phase.
The relationship between GeoSTM and GAC is not clearly regulated, especially the use of NMI metrologists as the most competent evaluators of measurement issues in the accreditation process.
There is no coherent development strategy for the NMI for organizational and personnel development, marketing (development of services), and financing.
The competences of the NMI within GeoSTM as a real NMI that ensure the traceability of the measurements to the SI must therefore be continuously improved according to the most urgent needs of Georgian economy and society. The following steps are necessary:
(a) Investment in upgraded equipment and laboratories in accordance with the development of national real and foreseeable demand.
(b) An appropriate building with the necessary environmental conditions for accurate measurement is needed. The government must decide whether (i) the current building will be reconstructed, (ii) another adequate building will be reconstructed, or (iii) a new building will be constructed.
(c) Development and implementation of a strategic development plan for the next 10 years, which contains a business plan with a personnel development plan, a marketing plan and a definition in which way the financing by State budget, services and national and international projects will be assured to obtain sustainability.
(d) Establishment of a clear internal administrative and responsibility structure that meets international rules and practices.
(e) Development of a strong relationship with key stakeholders by funding an advisory board and organizing awareness activities for current and future clients and interested parties (seminars, workshops, special publications, and mass media).
(f) Contracting of new young personnel for the most needed magnitudes: mass, temperature, electricity, physical-chemical analysis, dimension, and, in the future, force, pressure, and volume. The best option would be a first group of six to eight persons in 2010 and a second group of the same size later in
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2011. Such a massive employment increase could produce synergistic effects in the future education of these young people.
(g) Organizing of a training program that ensures that the new metrologists can fulfill their tasks within a period of four to eight years. In special fields, the existing staff also must be qualified.
(h) English courses for the staff.
(i) Implementation of a QMS according to ISO 17025 for the NMI as a whole and for the particular laboratories ...
(j) Gradual preparation and participation in key and complementary intercomparisons with the objective that the calibration and measurement capabilities (CMC) can be registered in the BIPM database as a precondition to being internationally recognized as the NMI of Georgia.
(k) Preparation for international recognition of the NMI laboratories by peer review of COOMET institutions.
Results of the survey and the assessment of the NMI within GeoSTM show that priority should be given to the following magnitudes: Temperature, Electricity, Pressure, Mass, Volume, Length, Density, pH metry. If one considers future economic and social development, other magnitudes such as the following will also be important: Force, Gas mixtures and gas analyses, Reference materials and certified reference materials. The scope of the physical-chemical laboratory should be defined, including a program of desirable CRMs, CRM certification, and proficiency testing scheme reference value assignments. Possibilities for establishing cooperation with other CRM producers should be investigated. Simple calibration of chemical analysis/measurement equipment is in general useless. In chemical analysis one needs to calibrate the complete measurement procedure, including the sample preparation, before one can start to measure. In many cases the largest uncertainty component comes from the sample preparation. Therefore one needs to calibrate the whole procedure, including the sample preparation and measurement device as a whole, with reliable traceable CRMs. As these CRMs are seen as costly and not easily available in Georgia on should consider whether the GeoSTM could play a role in centrally buying the needed CRMs abroad. The possibility of designating one or more expert laboratories to act as an NMI in a well-defined field of metrology where GeoSTM does not have proficiency should be studied in the near future. There is a considerable need for chemical analysis in the fields of food quality and safety, clinical measurements, pharmaceuticals and environmental measurements so that it is recommendable to investigate whether one or more experienced chemical laboratories in Georgia could become an officially Designated Institute acting as an NMI responsible for a well defined area of chemical metrology. It can be started up in parallel to the further highly needed development of the GeoSTM NMI. Another possibility exists in the field of electricity (Geolit). It would accelerate the process of obtaining traceability and diminishing its costs.
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Also, GeoSTM should help the Ministry of Health to establish links with the Joint Committee for Traceability in Laboratory Medicine community and assist in the development of clinical reference laboratories in Georgia. This development requires coordinated international support in renovating and upgrading the technical means at all levels, from national standards to working measurement instruments in testing laboratories, clinics, and shops, to ensure the traceability and recognition of the measurement results.
4.2. The National Standardization Body within the Georgian National Agency for Standards, Technical Regulations, and Metrology
4.2.1. Legal Basis and Tasks
The directorate for standardization within GeoSTM is a result of the reforms introduced in 2004–05. It fulfills the tasks of an NSB. The legal basis includes the following:
Georgian Law On Standardization from 1999 with the amendments and supplements made in June 2005.
Order N1-1/1057 of the Ministry of Economic Development (MoED) of Georgia, October 7, 2005 “On Approving Charter of the Legal Entity of the Public Law—National Agency for Standards, Technical Regulations, and Metrology”
The Georgian Law On Standardization stipulates the main goals and principles of national standardization in line with international and European ones but there is still an important gap in the function of the NSB. There is no specification of a standards preparation structure compatible with international and European practice which involves standardization technical committees where all interested parties can participate, is unspecified. The law specifies that the NSB is entitled to “register” standards. This is a legacy of the Soviet era where all enterprises were required to register in-house industrial standards at the Goststandard Agency. These stipulations are not in line with the requirements of the World Trade Organization (WTO) Code of Good Practice for the Preparation, Adoption and Application of Standards for NSBs and for international and European practice. National standards should be prepared and adopted by NSB and its structure — the technical committees. The main functions of NSB should be is to prepare and adopt national standards, not to register them. For clarity in the international context, it would be effective to eliminate “Technical Regulations” in the name of the agency. The application of Georgian national standards is voluntary. Although the agency’s name is the Georgian National Agency for Standards, Technical Regulations, and Metrology, GeoSTM as the NSB does not have a mandate to develop or adapt technical regulations (except metrology) or to enforce them. The agency’s management admits, however, that their advice is often sought and that their experts will presumably continue to play a role in setting technical regulations, for example, with regard to the analysis of foreign regulations.
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4.2.2. Structure and Work of the NSB within GeoSTM
The NSB within GeoSTM is headed by a director and has its own official management. It is financed partially by the MoED budget (budget staff) and partially by selling standards. The price of the standards (20 Lari) is very modest in comparison with what companies must pay in European countries. The directorate has the following units:
Standardization unit
WTO Technical Barriers to Trade (TBT) inquiry point and notification authority
Information technology unit (for all GeoSTM)
Library and information center
Publishing services.
On paper, GeoSTM/NSB manages 23 technical committees. According to the director of the standardization department, however, only two committees are active:
Quality Management and Conformity Assessment Committee (19 members)
National Electrotechnical Committee (13 members).
The establishment of the following technical committees is said to be imminent:
Food products
Construction products
Oil and oil products.
Agency management stressed the fact that the establishment of the technical committee on construction products was expressly demanded, which is very seldom the case in Georgia, by manufacturers of construction products. The NSB indicates that only approximately 15 percent of new standardization work is started on the initiative of interested economic operators. The remaining projects (85 percent) are initiated by the agency itself. One of the outstanding results of NSB’s work is the translation of the ISO/IEC series 17000 for accreditation into the Georgian language by a special technical committee and the approbation of the developed technical terminology by the Georgian Academy of Language. Thus, a better foundation was created for understanding the international language of quality infrastructure. This document will not only help translate other standards, but also improve the education in matters of standardization and measurement in the universities. Important weaknesses are related to the few links to stakeholders:
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The number of technical committees that are actually working (two) is extremely small.
The survey showed that the services of the standardization department are insufficiently disseminated and, in many cases, unknown. For example, many enterprises were not aware that Georgian national standards in force are mainly adopted international or European standards. They also do not know about the translation of the ISO/IEC series 17000 because they did not participate in it or were not informed about it.
The interviewed enterprises are requesting improved access to the international standards.
No supervisory board represents the main public and private stakeholders and developing standardization policy. It is said that the legislation must be changed for the implementation of such a supervisory board.
The agency is a corresponding member of ISO and IEC and an affiliate to the European regional standardization bodies, European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC).18
4.2.3. Staff and Equipment
The agency’s standardization department employs 10 permanent staff members financed by the budget, and six persons who are paid with the receipts of GeoSTM. They are distributed over the following units:
Standardization unit
WTO TBT inquiry point and notification authority
Information technology unit
Library and information center
Publishing services
The number of budget- and nonbudget-financed staff seems reasonable for a country that is adapting international standards to national conditions in accordance with the needs of economy and society. The staff has attended many training sessions since Georgia joined the WTO in 2000 with the result that there exists a certain technical competence for developing standardization work. What must be improved are the English-language facilities. The agency’s standardization department staff members are relatively well equipped with computers and relevant office, information, and communication technology equipment in general. However, the agency’s facilities are completely inadequate.
18
The CENELEC affiliation became official in the first week of June 2010.
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4.2.4. Recommendations
Adapt the existing legislation to international standards and practices.
Gradually create a homogeneous and consistent collection of national standards that adequately serves the needs of standards users, legislators, conformity assessment bodies, and enforcement authorities alike:
Phase out obsolete GOST standards for which there are immediate and adequate alternatives (European Norms, ISO, IEC, and others).
Adopt coordinated European standards in priority sectors, and translate the most urgently needed standards.
Gradually abolish the practice of registration of company specifications.
Make it a general policy to adopt international standards.
Avoid inconsistencies among national standards or those that are accepted for compliance purposes.
Establish an adequate committee structure for standardization work in priority sectors, including the establishment of technical committees that are in real demand and that mirror the technical work done at the regional and international levels.
Review standardization governance and management structures so that the NSB is governed by a superior body that has a truly balanced representation of the major parties interested in standardization. This principle of balanced representation should also be introduced to the technical bodies (technical committees, subcommittees, and working groups) so that they can have the highest possible degree of autonomy concerning the technical issues at stake.
Train technical staff
Train technical staff on best practices, work procedures, organization and management of the technical work, and the use of information and communication technology tools for standardization purposes.
Introduce the concept of a modern technical officer (a combination of technical committee secretary, project manager, communication officer, customer adviser, and trainer on voluntary standardization).
In the mid to long term, separate the NMI and NSB of GeoSTM into completely independent bodies for best governance results. Whereas the NMI must be a public institution, the NSB can take one of many other (private or mixed) institutional forms. At minimum, if the two remain housed in the same institution, responsibilities, budget and decision making processes need to be completely separated and independent.
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4.3. The Georgian Accreditation Center
4.3.1. Legal Basis and Tasks
As part of GeoSTM, GAC is the result of the reforms of the NQI in 2004–05. The Center was founded as the national accreditation body (NAB) in 2005 and began operation in 2006. Part of the staff came from the dissolved Sakstandarti, and some were newly hired.
4.3.2. Structure and Staff
An organizational structure in accordance with international requirements was not implemented at the time of the study (Figure 11). The following were lacking:
(a) An accreditation board with participation of the stakeholders and NQI institutions (NMI and the standardization department) who will advise the ministry with respect to accreditation.
(b) Technical advisory committees.
According to GAC, the accreditation board is missing because of legal barriers that will be overcome when the new quality code is established and has passed the parliament.
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Figure 11: Organigram of GAC
Source: GAC.
With a permanent staff of 14, GAC seems to be adequately sized. Everyone on the technical staff has a university degree. The administration is relatively small and sufficient. In the future, the permanent staff can be largely self-financed when the ISO/IEC norms and the International Laboratory Accreditation Cooperation/International Accreditation Forum (ILAC/IAF) guides are fully applied. The main challenge is that at the moment many of the laboratories cannot fulfill the requirements. Also for this reason a business plan (organization and staff development, marketing, and financing) should be developed to have a better vision of what the real demand will be in the future. GAC works with a pool of external experts. The cooperation with the NMI within GeoSTM for contracting experienced metrologists for the assessment process of calibration and testing laboratories is not regulated and produces potential conflicts of interest, sine GeoSTM provides calibration services which could compete with accredited calibration laboratories. A solution must be found in the near future. The increasing involvement of the GeoSTM laboratories in the international metrology network (COOMET, BIPM, and others) will ensure that GeoSTM employs those experts
General Director 1
Technical Advisory Committees
(advisory bodies of the GAC General Director)
calibration
testing
certification of metrology standards
certification of products
certification of persons
inspection
Public and Information Department
Financial Department
Accountant 1
Material Supply and Transport Specialist 1
Accreditation Committee (proposals concerning issuing of accreditation certificates)
Technical Assessors and Experts
Lawyer 1
Head
Secretary 1
Lead assessors 8
Head
Department for Assessment of Conformity Assessment Bodies
Quality Manager (Deputy Director)
1
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who know best the international measurement standards, uncertainty estimations, documents, and so forth. More than half the staff members are less than 40 years of age which is an advantage on one hand in comparison with GeoSTM. On the other hand, the professional experience that is so necessary for an accreditation body must be developed. Older GAC staff members and lead assessors are not sufficiently familiar with the ISO/IEC 17025 criteria and the way the ISO standard is implemented. In particular, they do not understand issues like traceability and measurement uncertainty, crucial elements for international recognition of measurement and test results. GAC has accredited some 150 conformity assessment bodies, of which about 90 are calibration and testing laboratories that still operate according to the obsolete European standard EN 45001. GAC’s large number of accreditations in such a short time raises questions about the quality and credibility of its accreditation process up to 2009, and in particular the documentation of measurement traceability, the estimation of uncertainty, and the assessment of environmental conditions (temperature, humidity, dust, etc.). Four laboratories are accredited in conformity to the latest international standard ISO/IEC 17025. GAC accreditation of laboratories is based on traceability obtained from GeoSTM in the form of legal verification instead of calibration. This practice is not in compliance with the ISO/IEC 17025 standard and will delay GAC’s international recognition. However, the EN 45001 standard includes essential requirements of the ISO/IEC 17025 standards like quality assurance during collection of samples, definition of measurement uncertainty, validation of measurement methods, and traceability of measurement devices. Unfortunately, these requirements are not fully applied in Georgia.
4.3.3. International Cooperation
GAC has applied for a contract of cooperation with the European regional accreditation organization, the European co-operation for Accreditation (EA). The international recognition by a peer review of EA and the assignment of the mutual recognition arrangement and multilateral recognition arrangement can be achieved in the next three years for the first types of conformity assessment bodies. Once GAC signs such an agreement, it can become a full member of ILAC (currently GAC is an affiliate member) and have its accreditations recognized worldwide.
4.3.4. Recommendations
During the past two years, GAC has tried to develop its activities in accordance with international and European standards and best practices, under the influence of international cooperation projects and its own experiences. Recommendations can be summarized as follows:
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GAC must define a development strategy that defines the steps needed to obtain international recognition by peer reviews of the respective international organizations in a reasonable time frame.
The development and implementation of a business plan (organizational and staff development, marketing, financing, and so forth) can be based on a realistic prognosis of the market development for accreditations services. In the case of testing and calibration laboratories, a real estimation of the capacities of existing laboratories to improve their competences (staff, equipment, environmental control, and fulfillment of the requirements of ISO 17025) is necessary.
The GAC staff has attended many training sessions and seminars, and practical training and internships are also necessary in the future. Nevertheless, the main point for future development toward becoming an internationally recognized NAB consists of applying the relevant ISO/IEC standards in the accreditation process in Georgia, as well as the continuous evaluation and improvement of technical competence. According to the recommendations of the international projects, GAC has initiated this process, but it must be accelerated.
It is also recommended to assess the laboratories in accordance with the checklists of EN 45001 (national accreditation) and ISO/IEC 17025 for facilitating the transfer after the changes to the legal basis. In many issues, the ISO 17025 means an improvement for the laboratories.
Many countries are starting to accredit clinical testing laboratories on the basis of the international standard ISO 15189 is starting up. GAC should train personnel and experts in ISO/IEC 15189 to start accreditation activities in accordance to this international standard. More reliable clinical test results will contribute to lower costs in health care. As there will not be many clinical reference laboratories in a country, the accreditation of those laboratories in compliance with ISO/IEC 15295 does not have the same priority as other types of accreditation. Cooperation with foreign accredited laboratories should be developed.
4.4. Market Surveillance and Inspection
4.4.1. The situation in early 2010
When the government began eliminating corruptive processes in Georgia in 2005, most inspections were eliminated because it was assumed that they were not fulfilling their tasks (control and protection) and that they were a source of corruption. Food inspections were totally abolished. Since 2005, some technical regulations were adopted in the fields of transport and hazardous industrial equipment. Because of the lack of clear responsibilities for technical regulations and because of limited technical competence, Georgia decided to recognize the technical regulations of 25 European Union (EU) countries, Israel, and 10 Organization for Economic Co-operation and Development countries “including all EU Directives in accordance with the New and Global Approaches” and to “allow for their
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application in the territory of Georgia” (Governmental Resolution 45 of 2006). In practice, the recognition of these technical regulations seems to mean that products from the respective countries are admitted into the country either without further formalities and conditions or, in the case of products covered by New Approach directives, if the Conformité Européenne (CE) marking was affixed. Some market surveillance for industrial goods was carried out by the Architectural-Construction Inspection and the Technical Supervision Inspection. The intention to merge these two inspections was on the table, and that merge might be imminent. Whether merged or not, however, there is no doubt that the existing inspection services are unable to cover all product areas in the market that require monitoring and checking. The Georgian government is developing new technical regulations based on the New Approach of the EU and the relevant European Directives. These regulations concern hazardous products, but Sanitary and Phytosanitary Standards (SPS) inspections along the production chain of foodstuffs will be introduced in the next few years. This comprehensive task has a very narrow relationship with the main services of the NQI (metrology, standardization, and accreditation) and requires a strong cooperation and coordination between the relevant ministries, regulatory agencies, and NQI institutions. The task requires not only the formulation of new technical regulations, but also the preparation of staff in technical competences, training in the new inspection methods, and the installation of new equipment. The inspections must be undertaken throughout Georgia.
4.4.2. Recommendations
Recommendations are as follows:
In the case of technical regulations and market surveillance, new legislation on general product safety and producers’ liability for defective products should be rapidly developed and implemented and the necessary personnel adequately prepared through training, internships, and so forth.
The capacity of line ministries for the development, adoption, and implementation of technical regulations should be strengthened. The establishment of interdisciplinary and interministerial working groups for developing and implementing priority technical regulations should be promoted.
Effective mechanisms should be introduced to ensure food safety (balanced checks along the entire value chain and proactive market surveillance) without further delay. This effort involves, among other activities, legal acts and the training of market inspectors in international and EU surveillance methodology and practice.
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4.5. Calibration and Testing Laboratories
4.5.1. Current Situation
The existing calibration and verification and testing laboratories, whether in-house or commercial, demonstrate a very different picture. Many of them use old Soviet equipment that applies the measurement methods and standards of that time. In these laboratories, one or two modern devices for completing the equipment were sometimes bought. Only in the past two years the staff of these laboratories has been partially included in training courses offered by international projects on ISO/IEC 17025 and other relevant standards and guides. The staff of most of these laboratories have little knowledge and understanding of measurement uncertainty, traceability of measurements, and validation of methods. This situation will have deep consequences for the development of the accreditation market because these laboratories are not ready to apply for accreditation. The situation will also hinder the fulfillment of European and other foreign market requirements. Nevertheless, a few laboratories have or will soon have a fully installed QMS according to ISO/IEC 17025. In particular, such laboratories received intense support from European and other foreign institutions like Weinlabor, Intertek, or Forensics Bureau laboratories. Some others installed their own QMS on their own like the laboratories of GMP and Aversis (two leading Georgian pharmaceutical firms) or Geolit (a calibration and verification laboratory for electricity). Their staff understand the requirements of the standards, and the laboratories have appropriate environmental conditions. Unfortunately, not all the well-equipped testing laboratories have understood the necessity of being trained in the international testing and measurement methods and standards and of applying them. This situation means that a very intensive effort must be made in the next few years if Georgia is to accomplish the international requirements. Otherwise the conformity assessments will have to undertaken mostly abroad, increasing costs and time requirements and causing barriers to technical knowhow, particularly for SMEs. In clinical testing laboratories testing results are very often different depending on the testing methods applied, the instruments and the quality of the reference materials. The Ministry of Health and some of the clinical testing laboratories are aware of the problem and are looking for solutions. In Europe and other countries the accreditation of clinical laboratories in on the basis of ISO/IEC 15189 is now widely starting up. Clinical reference laboratories have to comply with ISO/IEC 15195, but there will not be many clinical reference laboratories in Georgia, so that it should not get the highest priority. One should focus on the large group of ordinary clinical testing laboratories. More reliable clinical test results will contribute to lower costs in health care and improve the health situation in the country.
4.5.2. Recommendations
In essence, four challenges must be overcome:
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(a) Training the staff in modern measurement and testing standards and
methods.
(b) Implementing the relevant ISO/IEC norms (ISO/IEC 17025, ISO/IEC 15189, ISO/IEC 15195 and ISO/IEC 17020).
(c) Improving environmental conditions in the laboratories according to relevant international standards and ensuring a stable power supply.
(d) Modernizing the measurement and testing devices.
A crucial point is staff training because the improvement of the current situation depends essentially on the awareness and understanding of the personnel in the laboratories. For this reason, future training courses should be offered on three different levels:
Basic level: Training in the fundamentals of the standards and the practical implementation of the requirements, in particular ISO/IEC 17025, ISO/IEC 15189, ISO/IEC 15195 and ISO/IEC 17020. These “courses for beginners” could be taught by well-trained GAC collaborators and laboratory experts as co-trainers. Widespread demand for this level of training exists in Georgia.
Trainee level: Some laboratories could actively cooperate and implement the roadmap of the 20 milestones19 in small working groups. In short sessions facilitated by a moderator, the participants together would develop the procedures, instructions, quality manual, documents, proficiency tests, and leaflets for collecting samples, estimating uncertainty, and validating methods and traceability of the measurements. Such a model was successfully implemented in some Caribbean countries.
Advanced level: The more developed laboratories, which already have established quality systems and programs, need expert advice, particularly for investigating reasons for measurement errors. The use of information technology instruments, such as an Internet hotline or Skype, could be very helpful and save time and money. These tools connect Georgian laboratory staff members with a pool of international experts (the Czech Republic, Germany, Lithuania, Turkey, and the United Kingdom).
The laboratories should participate more directly and actively in the NQI development process, particularly by having their representatives participate in the Quality Council and the different supervisory bodies and committees. The stimulation of the foundation and the development of laboratory associations could strengthen this development. Their links to the relevant international organizations should be promoted.
19
“The Roadmap to an Accreditation System: 30 Milestones for Developing Countries” is a guide for preparing the internal conditions (structure, quality manual, necessary calibration certificates, and so forth) of the laboratories for accreditation by ISO/IEC 17025. It was developed by Physikalisch-Technische Bundesanstalt’s technical cooperation. See http://www.ptb.de.
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4.6. Certification Bodies
In Georgia, national certification bodies accredited by GAC and foreign companies from Germany, the Russian Federation, Ukraine, United Kingdom, and other countries are active, including TÜV Süd, TÜV Nord, Bureau Veritas, SGS, Russian Register, IQnet, and others. Primarily, they are certifying QMSs according to ISO/IEC 9001, ISO/IEC 14000, ISO/IEC 22000, and HACCP (Hazard Analysis and Critical Control Point) standards. The number of enterprises with certified QMSs is still relatively small. Some national testing laboratories are also accredited as product certifiers. But because these certificates are not internationally recognized, the documents are not valid outside the country. Internationally, certifying companies are not allowed to directly advise and train the firms that are preparing for QMS certification. Thus, some national consulting firms have detected this market opportunity. With increasing exports to European and other countries and an increasing quality conscience in Georgia, the demand for certification will increase. For this reason, it is urgent not only to develop GAC, but also to do the following:
Promote the certification process by awareness measures, matching grants, and other instruments.
Support the development of certifiers that are working in accordance with the ISO/IEC standards and can be accredited by GAC.
Facilitate the development of consulting and training firms that are able to support enterprises and laboratories in preparing the certification process
5. Future Needs from Economy, Trade and Society for the Development of the National Quality Infrastructure
Defining future needs for Georgia’s national quality infrastructure (NQI) requires a consideration of the following:
The current economic structure and social situation of the country and make a prognosis of the development over the next five to ten years.
The current international economic relations to identify possible trends over the coming years.
5.1. The Current Economic and Social Development of Georgia
Because of its location amid the Islamic Republic of Iran, Russia, and Turkey, between the Black Sea and the Caspian Sea, the country has a major geostrategic significance, which has influenced not only Georgia’s history, but also its economic structure. Georgia
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is an important transit country for oil, gas, electric energy, and merchandise between Europe and Armenia, Azerbaijan, the Middle East, and Central Asia. From the end of the 18th century through 1991, Georgia was under the influence of the Russian tsarist regime and was then a part of the Soviet Union. As in most other Soviet member republics, very few complete value chains existed in Georgia. The republic produced fruit and vegetables, mineral water, tea and wine, electrical appliances and fittings, railway engines and carriages, cement, rare metals, and so forth in enormous state-run companies. In addition, the Black Sea coast and the Caucasus region were extremely popular destinations for tourists from the Soviet Union and other socialist countries. Because of its location on the Black Sea and its long southern border with the North American Treaty Organization country of Turkey, Georgia played an important role in the defense strategy of the Soviet Union and the Warsaw Pact. This key position also influenced the economic structure in which the military-industrial complex played a significant role, mainly in advanced technology. The Tbilisi aircraft plant—still one of the largest industrial companies in the country and now privatized—produced the latest Sukhoi fighter aircraft. The National High Technology Center of Georgia, which was able to maintain its position as one of the five leading isotope institutes in the world, was also a significant player in Georgia’s economy. After the decline of the Soviet Union, a general process of deindustrialization occurred. The chemical, mechanical engineering, and aircraft construction industries, which had traditionally been closely linked to the other Soviet republics, have been at a standstill for years, are being used at only a fraction of their capacity, or have been closed. Agricultural production has suffered greatly as the main market, the Soviet Union, crumbled away. At present, the country has trouble supplying the population with basic agrarian products that were formerly domestically produced. The economic decline of Georgia also had some social consequences. Unemployment and poverty increased, and the education system deteriorated. In 2010, the United Nations Development Programme ranked Georgia 89th in its Human Development Index. After a decade of decline, the country entered into a period of accelerated growth at the beginning of the new millennium. The driving forces were the mining, construction, and manufacturing industries. In 2008–09, the financial and economic crises hit Georgia together with the rest of the world, but increased GDP growth is forecasted for 2010. The restructuring of the Georgian economy is a long and complicated process. Studies tried to define competitive industries and products, but these are early attempts. An International Finance Corporation (IFC) publication from 2009 (IFC-MIGA 2009), for example, did not mention the mineral water industry, which is a very important export industry (to Commonwealth of Independent States countries and Europe), and states that tea production is currently uncompetitive for various reasons. But nothing was written about a possible revival of the Georgian tea plantations, which had a good reputation in former socialist countries until the downfall of tea production in the 1970s. It is also unclear whether paper and packaging materials production could have a future.
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Another factor is that in a small and relatively undiversified economy like Georgia’s, changes from one year to the next are difficult to evaluate. Some changes are very slow while others can be very significant from one year to the next if investments in one or two industrial plants are completed. This could lead to false conclusions of growth. Table 7 shows the changes between 2006 and 2008, the last year before the financial and economic crises. The food, beverage, and tobacco industries continued to be important sectors, but the most important step was taken by the steel and metal industry. A former metallurgical plant in Telavi was bought by the Indian company Jindal Steel and began operating as GeoSteel, and a smaller plant in Kutaisi was also bought by an Indian steel producer. Thus, other new (foreign or national) investments in other industries will immediately influence the composition and the growth of the value added in the manufacturing industry. For example, the engagement of an Egyptian investor (Fresh Electric) in Kutaisi will increase the proportion of household appliances in the industrial output. The planned reconstruction of the port of Poti and the establishment of a free zone by United Arab Emirates (UAE) investors will also have an effect. Investments from Turkey and other countries will contribute to the growth of the energy sector.
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Table 7: Value Added in Georgian Industry, 2006–08
GEL % GEL % GEL %
Industry, total 964.5 100.0 1,291.1 100.0 1,636.6 100.0
Mining and quarrying 139.7 14.5 197.7 15.3 155.2 9.5
Mining of energy-producing minerals 44.9 4.7 79.0 6.1 68.6 4.2
Mining of coal 0.1 0.0 0.6 0.0 2.3 0.1
Mining of crude oil % natural gas 44.8 4.6 78.4 6.1 66.3 4.1
Mining of minerals other than energy producing 94.8 9.8 118.7 9.2 86.6 5.3
Mining of metal ores 82.5 8.6 101.5 7.9 73.0 4.5
Other mining and quarrying 12.3 1.3 17.2 1.3 13.6 0.8
Manufacturing 499.4 51.8 688.4 53.3 972.1 59.4
Food, beverages, and tobacco products 182.3 18.9 231.4 17.9 241.1 14.7
Textiles and textile goods 7.6 0.8 9.1 0.7 13.0 0.8
Leather, leather products and footwear 0.9 0.1 2.5 0.2 0.6 0.0
Wood, wood products, and cork 9.0 0.9 10.9 0.8 9.0 0.5
Paper and publishing 29.3 3.0 37.1 2.9 44.6 2.7
Oil and oil products 0.0 0.0 0.0 0.0 4.3 0.3
Chemical products 73.7 7.6 65.2 5.0 66.8 4.1
Rubber and plastic products 14.8 1.5 28.0 2.2 30.6 1.9
Nonmetallic mineral products 54.7 5.7 120.3 9.3 145.8 8.9
Basic metals and fabricated metal products 86.2 8.9 126.1 9.8 314.1 19.2
Machinery and equipment 11.8 1.2 15.4 1.2 16.8 1.0
Electrical machinery and optical instruments 6.2 0.6 9.2 0.7 14.0 0.9
Transport equipment 17.9 1.9 34.0 2.6 62.7 3.8
Other branches of industry 5.0 0.5 8.2 0.6 8.7 0.5
Electricity, gas, and water supply 325.4 33.7 405.0 31.4 509.3 31.1
Supply of electricity 254.0 26.3 294.6 22.8 374.7 22.9
Supply of gas 21.7 2.2 26.5 2.1 40.1 2.5
Supply of steam and hot water 0.1 0.0 0.1 0.0 0.4 0.0
Collection, purification, and distribution of water 49.6 5.1 83.8 6.5 94.1 5.7
2006 2007 2008
Source: World Bank. Note: GEL = Georgian Lari.
In sum, many uncertainties in Georgia’s economic development make it difficult to design a realistic picture for the next 5 to 10 years. If one considers the value added in industry, development over the past few years (Table 7 and Figure 12), and some expected investments in future years, the importance of the manufacturing industry could gradually increase relative to the mining industry. The most important branches of the manufacturing industry will be the following:
Metal products
Food and beverages (alcoholic such as beer, wine, and brandy; and nonalcoholic, particularly mineral water and juice)
Chemical products
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Nonmetallic mineral products, including construction materials
Wood, paper, and packing (may include also glass)
Transport equipment (railway equipment) and machinery.
Figure 12: Percent Share of Total Industry Value Added in Georgia, 2008
Source: German Trade & Invest.
5.2. The International Economic Relations and the Economic Competitiveness of Georgia
When Georgia was part of the Soviet Union, it did not have its own economic relations with foreign countries. After independence was achieved in 1991, and especially since the economic reforms in 2004–05, Georgia has began to be more integrated into the global economy. In 2000, Georgia joined the World Trade Organization (WTO). The country has also been a member of the Organization for Democracy and Economic Development GUAM (Georgia, Ukraine, Azerbaijan, and Moldova) since its foundation in 2001 and a member of the Black Sea Economic Cooperation, which was founded in 1992 on the initiative of Turkey. Of particular significance for Georgia has been cooperation with the European Union (EU). Georgia was included in the European Neighborhood Policy and in the Eastern Partnership (EaP)20 since its proclamation in 2008. With the decision to start negotiations on a Deep and Comprehensive Free Trade Agreement (DCFTA) with the EU, the relationship has gained a new quality.
20
The Eastern Partnership was announced on December 3, 2008, in Brussels. The participants are Armenia, Azerbaijan, Georgia, Moldova, and Ukraine. Belarus has also been invited to join.
mining of crude oil and natural gas:
4.1
mining of metal ores: 4.5 other mining and
quarrying: 1.0
food, beverages, and
tobacco products: 14.7
leather and textile goods: 0.8
paper and publishing: 2.7
chemical products (oil, rubber, and plastics): 6.2
nonmetallic mineral products:
8.9
basic metals and fabricated metal products: 19.2
machinery and optical
instruments: 1.9
transport equipment: 3.8
other branches of industry: 1.1
electricity, gas, and water supply: 31.1
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A central issue in Georgia’s economic situation is the abolishment of all of the Soviet and post-Soviet regulations in 2004–05, which hindered the development of a free market system. Perhaps in some cases, economic liberalization went too far. However, this policy had advantages in that all restrictions were eliminated, new people entered leading posts in the government, and the change process was accelerated and deepened as in no other post-Soviet country (exception the Baltic countries). In August 2008 Georgia left the Commonwealth of Independent States (CIS) and was no longer required to abide by the special decisions and regulations of this economic and political community. As a result of the reforms, Georgia is ranked 11th among the 183 investigated countries in the Doing Business 2010 report. Whereas in 2005 the registration of a new enterprise took 21 days, in 2010 only three days are necessary. The procedures for importing and exporting goods were also made substantially easier (IFC and World Bank 2009). The framework for international economic activities was improved, and the notorious corruption was practically eliminated. Conversely, the Global Competitiveness Index shows that Georgia is ranked 93rd, which probably explains why there are has been so little foreign direct investment during the past few years. Although the reforms were deep and long lasting, it cannot be expected that everything in Georgia changed for the better within just a few years. The current picture shows progress, but there are still many existing gaps and problems (see Table 8, and Table 9 and Figure 13 and Figure 14):
1. The social situation (employment, education, and income) is, as the Human Development Index shows, difficult and hinders more rapid development.
2. The foreign trade has been constantly increasing, but unfortunately the gap between export income and import expenditures has also increased, so the trade balance deficit composes 30 to 40 percent of GDP (Table 8). One of the causes is Russia’s embargo after the August War, but more important for the future is the lack of competitive products with a higher value added, like the metals and minerals that Georgia is exporting now.
3. Compared with other small countries (Bulgaria, the Netherlands, and UAE), Georgia’s proportion of trade in GDP is very low (Figure 13). It shows that the country has not yet found its place in the international division of labor.
4. In foreign trade, CIS countries’ influence is decreasing, particularly in exports (Russia). Meanwhile, Brazil, Canada, China, many EU countries, Turkey, the United States, and some Islamic countries such as the Islamic Republic of Iran and UAE are increasing their exports (Table 9).
5. Within the export structure, iron and steel products (a result of the new steel mills), mineral ores, pearls, and precious stones (mining industry) are leading. Alcoholic (wine and brandy) and nonalcoholic (mineral water and juice) beverages, fruits, and nuts are also represented. Cars and car parts include reselling imported cars and selling used cars mainly to Armenia and Azerbaijan. The share of pharmaceuticals and the importance of livestock (sheep to Islamic
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countries) are interesting components. Including some chemical products, construction materials, and machinery, this is the current main export goods structure (Figure 14).
6. An important export product that does not appear in these statistics is electrical energy. The main importer is currently Russia, but there could be potential in other neighboring states (Turkey).
7. EU countries import a more diversified range of products: mineral water, wine, fruits and nuts, ferrous alloys, copper, fertilizers, and others. The United States and Canada import mainly mining products. The remaining CIS countries that import from Georgia also have relatively diversified imports: mineral water, wine, cement, sugar, chemical products, and pharmaceuticals.
8. Turkey is a very important trade partner. In some cases, the Turkish branches of West European firms are active trade partners.
9. Imports among CIS countries have declined, and a significant diversification of the import countries (Brazil, China, Japan, UAE, and others) can be observed.
Table 8: Georgia’s Foreign Trade Balance, 1995–2009
1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Exports (US$ millions) 152 330 320 348 444 650 865 936 1,232 1,496 1,135
Imports (US$ millions) 395 651 684 731 1,058 1,846 2,490 2,678 5,215 6,305 4,378
Trade balance (US$ millions)-243 -321 -364 -383 -614 -1,196 -1,625 -1,742 -3,983 -4,809 -3,243
GDP (US$ millions) 1,909 3,043 3,210 3,302 3,948 5,300 6,400 7,700 10,180 12,800 10,750
Export/GDP (%) 8.0 10.8 10.0 10.5 11.2 12.3 13.5 12.2 12.1 11.7 10.6
Trade/GDP (%) 28.6 32.2 31.3 32.7 38.0 47.1 52.4 46.9 63.3 60.9 51.3
Trade balance/GDP (%)-12.7 -10.5 -11.3 -11.6 -15.6 -22.6 -25.4 -22.6 -39.1 -37.6 -30.2
Source: GEPLAC; Ministry of Economic Development of Georgia.
Figure 13: Openness of the Georgian Economy (%)
Source: Ministry of Economy of the Republic of Armenia 2009, 35.
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Figure 14: Georgian Export Products, 2009
Source: German Trade & Invest
iron, steel, and related products
17%
nonalcoholic and alcoholic
beverages11%
pearls, precious stones, and
related products10%fruits, nuts
8%
cars and car parts 8%metal ores,
cinders, and ashes7%
fertilizers5%
fuel, waxes, and bitumen
4%
livestock4%
pharmaceuticals2%
cement, salt, sulfur, earth, and stones
2%
oil seeds and plants, plants
2%
wood and wood products
2%
others18%
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Table 9: Georgian Exports and Imports, by Regions and Countries
Region or Country
2004 2008
Export Import Export Import
US$ (millions)
%
US$ (millions)
%
US$ (millions)
%
US$ (millions)
%
EU 126,314 19.5 649,215 35.2 331,957 22.2 1,753,617 27.8
Austria 311 0.0 22,258 1.2 3,002 0.2 70,324 1.1
Belgium 5,068 0.8 15,518 0.8 7,191 0.5 61,300 1.0
Bulgaria 15,552 2.4 36,875 2.0 108,217 7.2 124,101 2.0
United Kingdom 31,675 4.9 158,619 8.6 43,577 2.9 91,245 1.4
France 9,556 1.5 63,230 3.4 39,910 2.7 98,479 1.6
Germany 15,851 2.4 151,067 8.2 33,063 2.2 497,304 7.9
Italy 11,591 1.8 61,624 3.3 17,145 1.2 183,795 2.9
Netherlands 9,840 1.5 34,600 1.9 12,652 0.8 134,053 2,1
Romania 1,289 0.2 14,020 0.8 13,611 0.9 92,433 1.7
Turkey 118,607 18.3 202,089 10.9 262,910 17.6 940,480 14.9
CIS 327,640 50.7 654,269 35.4 541,601 36.2 2,001,046 31.7
Russian Federation 104,533 16.2 255,396 13.8 29,885 2.0 426,330 6.8
Ukraine 15,613 2.4 142,380 7.7 134,170 9.0 657,720 10.4
Armenia 54,408 8.4 26,297 1.4 123,422 8.2 72,078 1.1
Azerbaijan 25,327 3.9 156,388 8.5 204,534 13.7 607,396 9.6
Kazakhstan 7,568 1.2 21,423 1.2 22,040 1.5 54,755 0.9
Turkmenistan 113,442 17.6 32,675 1.8 6,338 0.4 135,024 2.1
United States 21,230 3.3 110,877 6.0 102,198 6.8 358,084 5.7
Canada 3,690 0.6 4,336 0.2 131,806 8.8 17,936 0.3
Brazil — — 36,856 2.0 8,889 0.6 104,182 1.6
Mexico — — 62 0.0 52,981 3.5 19 0.0
United Arab Emirates
2,787 0.4 46,722 2.5 11,229 0.8 276,880 4.4
China 3,307 0.5 28,904 1.6 8,983 0.6 298,331 4.7
Iran, Islamic Rep. 4,501 0.7 15,158 0.8 10,059 0.7 52,081 0.8
Japan 626 0.1 5,933 0.3 274 0.0 119,785 1.9
Others 38,201 5.9 91,134 4.9 33,173 2.2 382,116 6.1
Total 646,903 100.0 1,845,555 100.0 1,496,060 100.0 6,304,557 100.0
Source: Ministry of Economic Development of Georgia 2009, 265–73. Note: — = Note available. The short analysis of the export trends of the past few years and the development of the existing economic structure show that the following economic sectors could play a role
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for further economic development and will also define the demand for services of the NQI:
Wine, fruit, and vegetable production: Traditionally, wine, fruit, and vegetables have been Georgia’s main exports. Although the main market (Russia) is now closed, alternative markets can be envisioned. These new markets require a certain level of quality, including food safety. Niche markets, like certified bioproducts (for example, the successfully introduced label “Green Caucasus”), could play a more important role in the future.
Construction and construction materials production: Despite the global slowdown, the construction sector in Georgia, Armenia, and Azerbaijan is likely to remain relatively robust because of oil and gas and infrastructure and public sector projects. Some important internationally financed construction and investment projects (highways and port of Poti) will be implemented in the future. Foreign investments have been made in the construction materials industry, and some research and development projects have been carried out to develop new construction materials.
Pharmaceuticals and medical devices: Like construction materials, imported pharmaceuticals are a significant market in the Caucasus and Central Asia, with growing demand for lower-cost generics. Some national medium-size enterprises have grown in recent years, and they are eager not only to conquer the markets in neighboring and CIS states, but also to export to European countries.
Primary process industries: Given Georgia’s mineral deposits, the existing metallurgy sector, and the favorable business environment and position as a gateway to and from the Caucasus and Central Asia, mining and metallurgy could also contribute to export revenues and job creation. The recent investment by Indian firms in the reconstruction of Georgian steel production proves that the potential for higher value-added production exists.
Chemical industry and rubber production: Georgia has some experience in this field, and more development depends on future investments.
Fish, meat, and derivatives: Some plants near the coast and in Tbilisi process fish, and plants in other parts of the country process meat. The export potential is unclear, but in the future these enterprises must fulfill food safety requirements. In 2009 the most important export product was livestock (sheep).
Apparel: Turkish apparel firms have established relationships with major EU buyers, but they face rising costs and labor shortages. They are therefore looking for expansion locations, potentially in Georgia.
Logistics and transport services: As the natural entry and exit point among the Caucasus, Central Asia, and the rest of the world, Georgia is also the natural logistics and transport services hub for the region, for shipping, rail and road services, air
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cargo hubs, transhipment and intermodal hubs, and so forth. The port of Poti was bought by UAE investors and probably will be modernized in the near future.
Energy: With the planned integration of the Georgian Transmission System into the European electricity transmission network through Turkey, projects to export hydroelectricity to Turkey, and the existing and planned oil and gas pipelines, exporting and transporting energy will become more important in the Georgian export structure. Given Georgia’s natural resources and denationalized utility companies, Georgia could generate more revenues and jobs through further exports of power and even water to neighboring countries.
Tourism: Tourism could become a larger industry in Georgia with its Mediterranean climate, ancient civilizations, good beaches, spectacular mountains, and so forth. The quality of services must be ensured if the country is to compete with nearby countries like the United Arab Republic of Egypt, Greece, and Turkey that have established tourism industries.
5.3. The Impact of National and International Trends on Future Needs for NQIs
5.3.1. Industry and Trade
If one takes into account the analysis of the demand survey, Georgia’s current economic structure, and certain foreseeable trends, the needs arising from industry and trade are the following:
Upgrade the existing basic metrological services that assure the traceability chain for the most commonly used magnitudes: mass; flow; temperature; pressure; electrical quantities; relative humidity; length; and ionizing radiation for basic chemical quantities like pH, electrolytic conductivity, and liquid density. Sending measurement instruments abroad for calibrating can decrease the competitiveness of Georgian SMEs, at least in the middle run. Foreign investors also seek reliable testing results of their products within the country where they participate. As a good number of chemical analysis/measurement laboratories need traceable Certified Reference Materials in order to be able to calibrate their measurement systems it should be considered whether the NMI can organize joint purchase of needed CRMs abroad.
Strengthen the testing laboratories and conformity assessment bodies (product certification) for major export goods including metals, food and beverages, machinery, and electrical appliances, as well as goods destined for the domestic market, such as construction and construction materials. This improvement means establishing a documented chain of traceability of measurements, qualification of personnel, partial improvement of equipment, and, last but not least, the implementation of QMSs. In some cases, ISO/IEC 9001 and ISO/IEC 14000 are sufficient, but an accreditation according to ISO/IEC 17025 also seems to be relevant.
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Continue the harmonization and—if necessary—translation of the international standards as an increasingly important step. The use of the old GOST and technical specifications will decline; nevertheless, GOST will continue to have some importance in future years because of exports to CIS states. The GeoSTM/NSB must follow the real needs of the industry and other private and public stakeholders and be actively involved in developing demand-oriented technical regulations. As in other countries, the calibration, testing, certification, and accreditation documents need at least consistent versions in Georgian and English.
Harmonize the new technical regulations with European rules and directives in accordance with Georgian priorities, particularly the Measuring Instrument Directive (MID) (2004/22/EC) and the Prepackage Directive (76/211/EEC with some later amendments). The TBT strategy contains the relevant measures to be gradually implemented according to Georgian necessities and possibilities.
Establish accredited testing laboratories and certification bodies whose certificates are internationally recognized, to be competitive in international markets. For accreditation, the testing laboratories must prove their measurement capabilities by taking proficiency tests. The accreditation can be done by foreign accreditation bodies that have signed the mutual recognition arrangement–multilateral recognition arrangement of the International Laboratory Accreditation Cooperation/International Accreditation Forum (ILAC/IAF) or by GAC if it received international recognition by a peer review (European co-operation for Accreditation or ILAC/IAF).
Increase the percentage of Georgian enterprises that have established QMSs. The demand for certified QMSs according to ISO/IEC 9001, ISO/IEC 14000, HACCP, and ISO 22000 will increase.
Increase the development of quality services (measurement, standardization, testing, and certification) along the production chain (Box 3)
Box 3: High Costs for Calibrations Abroad: The Example of the Georgian Pharmaceutical Industry A leading pharmaceutical local enterprise in Georgia has established a production process and a testing laboratory that work extensively in accordance with international practice. The enterprise provides the local market and has initiated exports to CIS countries and others. For ensuring the quality of the final products, the enterprise needs many measurement instruments in the production process and in the laboratory that must be calibrated (manometer, thermometer, and hydrometer). Because GeoSTM cannot do it, the instruments are sent to Ukraine or Germany, which means not only that the instruments are out of service for about 45 days, but also that the cost is significant. The calibration of simple instruments in Ukraine costs only about €30, but the transport including customs costs about €200. For more sophisticated instruments, the ratio between calibration (done by Germany’s Physikalisch-Technische Bundesanstalt) and the additional costs is a bit
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better. The company estimates that beyond the €15,000 spent on calibrations abroad, the cost for transportation and additional elements is about €10,000. These costs could be saved if GeoSTM could ensure the traceability of the basic magnitudes. The pharmaceutical sector is a growing area in Georgia’s SMEs, so GeoSTM’s services would greatly help local SMEs.
5.3.2. Consumer Protection
The abolishment of most inspections, the practical inexistence of legal metrology (until late 2009), and the lack of market surveillance prevented consumers from having instruments or partners through which they can voice their complaints and protect their rights. At the moment, consumers seek better prices over quality. Existing consumer protection nongovernmental organizations (NGOs) are weak, mostly unknown, and not influential. If one takes into account the political willingness to bring the country closer to the EU in the near future, the following needs will develop:
Augment the legal metrology system for the most important items: trade scales, water meters, gas meters, electricity/kWh meters, flow meters (gasoline and gas-dispensing pumps), explosion protection, and so forth. This system needs not only trained personnel and technical equipment, but also the traceability to the SI (International System of Units) by means of the national measurement standards maintained by the NMI within GeoSTM.
Establish training for personnel, awareness measures for enterprises and state regulatory authorities, and adequate institutions to enforce and to monitor the implementation of the relevant EU directives.
Develop campaigns to increase consumer awareness for products that meet quality standards as part of improving consumer protection. In this context, NGOs, state authorities, and the media must play a more active role.
Strengthen the respective NGOs and independent testing laboratories for monitoring products and services. The main fields will be energy, water, gas, gasoline, scales, and food safety.
Implement a market surveillance system whose main elements correspond to European rules and practices.
5.3.3. Food Safety
With the increasing worldwide trade of food, the development of a food safety system from farm to fork is gaining importance. Food safety is also a priority objective in the Deep and Comprehensive Free Trade Agreement negotiations. The following trends can be observed:
The coordination between the two quality assurance systems in the field of food, the Sanitary and Phytosanitary Standards (SPS) and TBT will increase
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because the problems are linked and the increasing investments require more coordination. Cooperation among the QI institutions; the ministries of economy, agriculture, and health and their inspections; the Customs Authority; and other actors in the field is particularly necessary.
The NMI within the GeoSTM must gradually secure the traceability of the basic magnitudes. In particular, the demand for traceable reference materials will increase. As in most countries, this process can be supported by designated institutes, such as laboratories that have good equipment and well-experienced staff and are working in accordance with ISO/IEC 17025 and the respective guides. When the demand cannot be accommodated within the country, then companies must look for traceability provided by specialized foreign laboratories and institutes.
The food testing laboratories and certifiers need to coordinate their QMS standards, testing methods, and product certificates with international requirements and best practices. The importance of documented traceability of the magnitudes and reference materials will increase.
Food safety requires the implementation of certified QMSs (ISO/IEC 9001, ISO/IEC 14000, ISO/IEC 22000, HACCP, and so forth) in the enterprises. This requirement also refers to enterprises producing bioproducts that are a possible niche and those where certification of the production process and of the products is desirable. The demand will increase pressure by the international traders of the products.
The food safety systems recommended by the Codex Alimentarius and the EU directives require a rigid control and inspection of the products and the production process from start to finish along the production chain. The traceability of the final food products must be ensured. In this context, the development of quality services (measurement, standardization, testing, certification, and inspections) along the value chain will gain importance.
A change in the producers’ way of thinking is also necessary. The process of certification and the certificates themselves must correspond to international standards and practices. If not, the documents are unreliable. The current approach that some producers take—buying a certificate without corresponding documentation—is counterproductive in the short run.
5.3.4. Environmental Protection
Scarce natural resources, increasing waste, climate change, and environmental deterioration have provoked more regulations and protective measures that require environmental standards and standardized measurement and testing methods. In Soviet times, environmental protection did not have much priority. But now, Georgia has joined many international agreements that must be implemented. People have become more conscious of pollution’s dangerous effects on the quality of life. The following tendencies can be expected:
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There is an increasing interest in and demand for measurement of pollution of water (solid and microbiological), soil, air, and noise. The controlling exhaust fumes and measuring radiation (nuclear medicine and construction) will also gain importance. Standardized testing and measurement methods are necessary to make the results comparable.
Legislation, standards, and respective technical regulations must be coordinated with the EU.
The existing laboratories of the Ministry of Environment will play a more important role, and private laboratories will probably enter this area. What is needed is an increasing qualification of the staff in the application of the new measurement instruments and methods. The traceability of the measurements and their reliability must be secured.
The laboratories working in this field should have a QMS and be accredited according to ISO/IEC 17025.
The demand for traceable and reliable reference materials will increase.
5.3.5. Health Care
Health care is a rapidly developing field in the Georgian economy. New health care products and instruments are entering the market, and certified reference materials (CRMs) have been introduced into clinical chemistry and laboratory medicine. The more accurate measurement of cholesterol, blood fat, and other items helps improve the effectiveness of the medical treatment and save money. Proficiency tests for clinical and pharmaceutical laboratories allow them to compare measurement results and establish reliable methods. Many clinical laboratories implemented QMSs with the goal of improving the reliability of their results. The following can be expected:
The demand for implementation QMSs in clinical and pharmaceutical laboratories will increase.
The pressure to improve the accuracy of measurements in clinical tests will increase and create a certain demand for CRM with a documented traceability chain. This demand can be only partially satisfied by the NMI within the GeoSTM and possibly designated institutes. Integration in the international clinical laboratory networks, like the International Federation of Clinical Chemistry and Laboratory Medicine, and contacts with the Joint Committee for Traceability in Laboratory Medicine can improve the situation.
5.3.6. Efficient Production, Distribution, and Use of Energy
Georgia exports energy and is a transit country for oil and gas from the Caspian Sea now and from Central Asia in the future. Georgia will be included in the European electricity transmission network and will adjust its transmission lines to meet European standards (the existing 380 kilovolt lines will be replaced by 400 kilovolt lines). Improving energy efficiency is a goal of the Ministry of Energy. In this context, the requirements for better
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measurement and for the adjustment and application of international standards will increase, although this aspect has not yet been clearly perceived. The following tendencies will determine requirements in future years:
The change in transmission voltage, the continuity of electricity exports, the integration of Georgia into the European electricity transmission network and the measures for improving energy efficiency will increase the demand for more accurate measurements. Smart grids and new instruments need more exact and efficient measurements.
Improving efficiency also means improving reliable testing capacities for electrical devices.
The increasing use of natural gas and Georgia’s development as a transit country require improving the respective measurement capacities for flow and calorific value. The preparation for harmonization of standards and technical regulations has begun with the INOGATE Programme. Because of high costs, these problems cannot be resolved by only one country.
The transport and consumption of oil and fuel also call for more accurate measurements. The demand will come not only from industry (calibration), but also from households (verification).
Type approval and verification of gas and gasoline dispensers, gas meters, and electrometers are important measures for efficient use of energy resources and for consumer protection.
5.3.7. Water Supply and Treatment
Water supply and treatment are important issues for households, industry, and commerce alike. Controlling water quality and preventing water pollution are significant for human, animal, and plant health and for efficient use of water resources. Therefore, demand will increase for the following:
Reliable and traceable measurement of water consumption
Improved measurement and testing capacities of solid and microbiological pollution.
5.3.8. Research, Development, and Innovation
Technological research and development and the innovation process are not possible without laboratories that produce reliable testing and measurement results and standards. The objective of this study was not specifically dedicated to this theme, but research, development, and innovation (RDI) activities will also gain importance in Georgia in future years, mainly in those fields in which capacities already exist, such as the development of new construction materials or foodstuffs.
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RDI needs a solid metrological base with traceable national measurement standards. In some fields, it will be necessary to secure traceability from accredited laboratories outside the country.
The respective laboratories must implement QMSs (ISO/IEC 9001) to make test and measurement results reliable and comparable. In some cases, an accreditation that meets ISO 17025 standards would help to secure international recognition and comparability of the test and measurement results.
One of the weaknesses of Georgia’s NQI is the insufficient development of conformity assessment bodies. It would be interesting to promote the establishment of foreign and national certifiers in areas such as the following:
Testing services in the fields of chemical analyses, microbiology, constructive and engineering products, hygiene, and environment (testing laboratories).
Clinical and medical laboratories.
Inspection bodies for various products (food, water, hygiene, and environment) and technical fields (cars, lifts, cranes, boats).
Certification bodies for various products (construction and construction materials, food, beverages, electrical devices, water, and so forth) and services (accommodation and travel services, banking services, consulting, and others).
Implementation of management systems (QMS, Environment Management System, ISO 22000).
Specific development in the field of staff certification.
Development of local services concerning proficiency testing providers in Georgia.
It is also recommended to promote a good distribution of calibration laboratories across the country that can respond to the most commonly used regional requirements.
5.4. International Cooperation
The need for comparable standards, testing, and inspection results and the fact that one country alone cannot resolve all these problems foster the emergence and development of international organizations and networks in the field of QI. Increasingly, international organizations like the International Bureau of Weights and Measures (BIPM), International Committee for Weights and Measures (CIPM), International Organization of Legal Metrology (OIML), ISO/IEC, International Telecommunication Union ITU, ILAC, and IAF are developing relations with one another, building an international network of QI institutions. The number of mutual recognition arrangements of testing results and certificates based on the ISO standards and guides is increasing. Since 2005, Georgia has been very active in developing relations with most of the important international QI institutions. The work done by ISO and the European
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Committee for Standardization (CEN) was revitalized, and in 2010, Georgia became a member of IEC and European Committee for Electrotechnical Standardization (CENELEC). GAC established relations with IAF and ILAC and submitted a cooperation agreement with the European co-operation for Accreditation with the objective of becoming a member when the required conditions are fulfilled. After joining the Euro-Asian Cooperation of National Metrological Institutes (COOMET) in 2006, the NMI within GeoSTM became an associate member of the Meter Convention in 2008. Among the most important organizations, only OIML is missing, with whom a membership is recommended because of its involvement in legal metrology and technical regulations. When Georgia left CIS, its membership in European-Asian Committee for Standardization (EASC) was cancelled. Clearly, Georgia has oriented its international cooperation to worldwide development trends that will foster further development. For the future, Georgia must consider joining or cooperating with more specialized international organizations and subcommittees. An increasing active participation in the technical committees in the different international organizations (COOMET, ISO/IEC, EA, and so on) is necessary to help the further qualification of the top level specialists and to transmit information to users in Georgia. In the field of metrology in chemistry, new commissions of the BIPM-CIPM were founded, such as the Consultative Committee for Amount of Substance—Metrology in Chemistry and Joint Committee for Traceability in Laboratory Medicine. Participation in these committees could accelerate the development of services for chemical, clinical, and medical laboratories for CRM and for standardized testing and measurement methods. An important issue of the past few decades has been the emergence of associations of different types of laboratories on the national, regional, and international level. They work to improve performance of the staff and of testing methods and instruments and to standardize the testing methods. Well-known laboratory associations in Europe are Eurolaboratory (testing and product certification) and Eurochem (chemical analyses and measurement). In the field of clinical laboratories, one of the main actors is the International Federation of Clinical Chemistry and Laboratory Medicine. Respective associations must be founded in Georgia with the goal of focusing the interests of the laboratories within the country and to using the experiences of these international organizations.
6. Recommendations
If one considers the results of the reform process, the changes that were introduced in past months, and the government’s TBT strategy,21—which was agreed upon with the European Commission (EC) in preparation for the DCFTA and is linked to two other strategies, Sanitary and Phytosanitary Standards (SPS) and Competitiveness—the
21
The Government’s Strategy in Standardization, Accreditation, Conformity Assessment, Technical Regulation, and Metrology.
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following 12 points are critical for implementing an NQI that responds to the most urgent needs of Georgia: 1. Awareness of the complexity of the NQI and its importance for the competitiveness
of the Georgian economy and the improvement of the quality of life in Georgia must be increased by appropriate activities for all the interested parts of society: policy makers, businesses, academia, consumers, and consumer and environmental protection nongovernmental organizations. The services offered by the NQI institutions must be developed in accordance with demand and be disseminated through adequate marketing methods. Enterprises and laboratories are eager to receive training and consulting in metrology (calibration and uncertainty), standardization, and accreditation. There is demand for better and more timely information about new developments and the modernization of information instruments (websites, electronic materials, and so forth).
2. The gaps and weaknesses in the legal framework must be gradually overcome. The planned formulation of new NQI laws should include advice from international experts who know not only the international best practices, but also trends in international organizations like OIML, ISO/IEC, ILAC, and the International Accreditation Forum (IAF). The laws should be formulated in such a way that they will not need continuous reformulation. They should be based on the terminology of the ISO/IEC 17000 series.22 An important goal of the TBT strategy consists of introducing the most important European directives in Georgia. A consequent implementation and a permanent adjustment of the priority list corresponding to the development of real demand in Georgia are needed.
3. The implementation and further development of the TBT strategy and an NQI in accordance with international rules and domestic conditions require strengthening the participation of the main stakeholders in this process: public institutions, private enterprises, entrepreneurial organizations, laboratories, consumers, consumer and environment protection organizations, and academia. An important task is to dynamize the Quality Council as an active advisory board for the government for the implementation of the TBT strategy and the development of the NQI. In conformity with international best practices, the three main pillars of the Georgian NQI—NMI, NSB, and the National Accreditation Body (NAB)—must establish boards with representatives of the stakeholders to ensure balanced development in their respective areas. Possible legal obstacles must be eliminated in the upcoming new legislation. Technical advisory committees should be established to advise GAC and GeoSTM about their needs for metrological traceability. The Calibration Committee should have, for instance, subcommittees composed of the heads and experts of the accredited calibration laboratories for different measurement fields, including electricity, mass, temperature, force, pressure, dimension, chemistry, and so forth. In the middle or long run, an institutional separation of NMI and NSB should be undertaken for good governance. At minimum, if the two remain housed in the same
22
A good example is the amendment to the Measurement Law, which defines a small number of measurement instruments that are subject to legal metrology. Although the list may appear incomplete, it is the start to a solid introduction of legal metrology on a new, non-post-Soviet basis.
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institution, responsibilities, budget and decision making processes need to be completely separated and independent.
4. At the moment, metrology is the weakest point in the NQI. The national measurement standards must be continuously improved according to the most urgent needs of the Georgian economy and society, ensuring the dissemination of the International System of Units (SI) within the country. Investment in equipment and staff and, in particular, in an appropriate building is needed (environmental conditions and permanent and sufficient power supply). The government must decide whether (a) the current building will be reconstructed, (b) another adequate building will be reconstructed, or (c) a new building will be constructed. The building must have the necessary conditions for accurate measurement and must be able to be managed in an economically efficient manner. The national measurement standards are a public good to which all interested parties should have free access.
5. Attracting young English-speaking staff with development potential for the NQI institutions is an important task, especially for the NMI because of its nonoptimal age structure. Better salaries are needed, as well as good working conditions, a pleasant atmosphere, and interesting development perspectives.
6. The existing deficiencies in the qualification of the staff in all the relevant NQI institutions as far as the rapid development of standards, methods, policies, and international best practices require continuing education of the staff. The process should not be restricted to the presentation of theoretical knowledge, but concentrates on practical application; exchange of experiences; and best practices, internships, and coaching.
7. The idea of obtaining international recognition of the NMI within GeoSTM (by signing the International Committee for Weights and Measures–Mutual Recognition Arrangement (CIPM-MRA) and the GAC (by signing the Mutual Recognition Arrangement/Multilateral Recognition Arrangement (MRA/MLA) of EA and becoming an affiliate member of ILAC and IAF) by peer reviews of the respective international QI organizations must be transformed in the development strategies of the two institutions that are defining the crucial steps to prepare a successful peer review. In the case of NMI, it implies the preparation and realization of calibration and measurement capabilities and the implementation of a QMS conforming to ISO/IEC 17025 and the special requirements for NMIs. In the case of GAC, training, internships, and a consequent application of the relevant ISO/IEC standards in the accreditation process in Georgia are required. The cooperation with the NMI within GeoSTM in the case of the accreditation of calibration and testing laboratories must be formalized. It must be considered that NMI does not need NAB for international recognition, but NAB needs NMI for traceability, uncertainty, and professional expertise.
8. Internal organizational strengthening, limited financial resources, and the development of services for the different clients of the system require the development of business plans for NMI, NSB, and GAC that contain financing, marketing, and staff development. The state budget contributions to the financing of the institutions versus the institutions’ own responsibility must be clearly defined. A
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stronger contribution by the State budget especially for the NMI is needed (salaries and international activities).
9. The tasks with which Georgia is confronted cannot be resolved by the national institutions alone. International cooperation is needed and perhaps division of labor. The existing relationships with QI institutions in Turkey, Ukraine, and some EU countries (the Czech Republic, Germany, Lithuania, and the Slovak Republic) should be strengthened and used to support a more rapid development of the NQI. Within the South Caucasus and Central Asian states, for example, the NMI within GeoSTM could develop a leading role in the metrology of electricity and ionizing radiation based on its current expertise and further foreseeable development.
10. The consequent development of memberships in the most important regional and international QI organizations is indispensable. BIPM, CEN, CENELEC, COOMET, EA, IAF, IEC, ILAC, ISO, and OIML (relationships exist with all except OIML) are important institutions where an active participation of Georgia is necessary. In particular the experts from the NMI and GAC should participate in the BIPM, COOMET, OIML, ILAC, IAF general assembly and working group meetings. In the build-up period the experts can learn a lot by attending the different relevant working group meetings. This is essential to learn what to do and what not to do. Further, this active participation contributes highly to building up mutual confidence and will later facilitate international recognition. At the moment, a portion of the membership fees is paid by international projects. In the future, the fees will need to be paid by Georgia.
11. Important actors within the NQI are the testing and calibration laboratories including clinical testing laboratories as a very important group. For them, better and more extensive training in the internationally used testing methods and QMSs (ISO/IEC 17025) is needed. For the implementation of ISO/IEC 17025, qualified training and consulting is requested. Most of these actors also need upgraded measurement devices and investments in the environmental conditions. Once the traceability of the measurement units is established by NMI within GeoSTM and is internationally recognized by GAC, nothing will impede them from developing tests whose documented results are internationally accepted.
12. In the case of technical regulations and market surveillance, the new framework legislation on general product safety and producers’ liability for defective products should be rapidly developed and implemented and the necessary personnel adequately prepared by training, internships, etc. A first step in Legal Metrology was done and should be continued. The role of government market surveillance should be strengthened.
13. If the Georgian government intends to help prepare SMEs to be competitive in the export markets (and in the future, also in the domestic market), it must plan ways to encourage SMEs to introduce certified QMSs, for example, through financing programs and information campaigns. Such measures could support improved awareness of quality issues in the enterprises and promote value added production. For such measures, highly developed services of the NQI are requested (calibration of the measurement instruments, delivering of standards, consulting, training in measurement and in QMS, and so forth).
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Besides these overall recommendations referring to the whole NQI, some specific suggestions should be made for the main components. As a result of the demand survey and the assessment of the NMI within GeoSTM, the following points are recommended:
The following priorities resulted from the demand survey of enterprises and laboratories: temperature, electricity, pressure, mass, volume, length, density, pHmetry.
Several instruments are applied in extreme ranges (for instance, temperatures up to 1,230°Celsius). In the medium term, such instruments should be calibrated abroad.
If one considers future economic and social development, some other magnitudes will be also important: force, gas mixtures and gas analyses, and reference materials and certified reference materials
The scope of the Metrology in Chemistry laboratory should become defined, including a program of desirable certified reference material (CRM) (such as measurement capabilities, purity analysis, value assignment of samples, customers’ in-house reference and working standards, CRM certification, and proficiency testing scheme reference value assignment). Possibilities for cooperation with other CRM producers abroad must be investigated where GeoSTM could play the role of a central buyer. The designation of advanced and appropriated testing laboratories as national reference institutes could foster the process of the GEOSTM’s international recognition.
The possibility of designating one or more expert laboratories to act as an NMI in a well-defined field of metrology in which GeoSTM cannot actively participate in the near future should be considered. GeoSTM remains the designating and coordinating NMI of Georgia.
GeoSTM should help the Ministry of Health in establishing links with the Joint Committee for Traceability in Laboratory Medicine (JCTLM) community and assist in the development of clinical reference laboratories in Georgia.
The further development of NSB within GeoSTM includes the following aspects:
Gradually create a homogeneous and consistent collection of national standards that adequately serves the needs of standards users, legislators, conformity assessment bodies, and enforcement authorities alike. This process means, among other things, phasing out obsolete GOST standards for which there are immediate and adequate alternatives (EN, IEC, ISO, and others), adopting coordinated European standards in priority sectors, and gradually abolishing the practice of registration of company specifications.
Establish an adequate technical committee structure for standardization work in priority sectors.
Review standardization governance and management structures (superior body, technical committees, subcommittees, and working groups), which should have the highest possible degree of autonomy concerning the technical issues at stake.
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Train technical staff on good standardization practices, work procedures, organization and management of technical work, and use of information and communication technology tools for standardization purposes, and introduce the concept of a modern technical officer.
Beyond the previously mentioned recommendations, GAC should undertake the following activities:
GAC should rapidly develop its competence to accredit laboratories in accordance with ISO 17025:2005 requirements. This competence requires further training of GAC staff in ISO/IEC 17025 and specific training in understanding traceability and measurement uncertainty. GAC should also promote the development of training and consulting from outside the institution to support the interested laboratories in better preparing their conditions for the accreditation. GAC cannot do it from within because of a conflict of interests.
GAC staff should be further trained to understand and properly implement the accreditation standards (ISO 17011, ISO/IEC 17025, ISO Guide 34, and other ISO CASCO standards). Practical training abroad and practical implementation accompanied by a coaching process could improve this situation.
GAC should prepare to introduce the ISO/IEC 15189 for clinical testing laboratories.
GAC should stimulate GeoSTM to organize proficiency testing schemes for accredited and nonaccredited calibration and chemical analysis laboratories, as well as for CRM producers.
Consumer protection should be emphasized. The following therefore seems necessary:
Strengthen the consumer protection organizations (NGOs).
Improve relevant inspections and consumer information by the government.
Include the mass media into this work.
Recommendations for technical regulations and market surveillance include the following:
Strengthen the capacity of line ministries for the development, adoption, and implementation of technical regulations, which requires training officials on legal, administrative, and technical issues, to promote the establishment of interdisciplinary and interministerial working groups for the development and implementation of priority technical regulations.
Establish a coordinating body for the distribution of technical legislation to the relevant parts of the European Acquis (and general good regulatory practices) with an adequate mandate and sufficient power and capacity.
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Chart all legal, technical, and administrative issues concerning the distribution exercise, and develop adequate and detailed strategies and policies for their resolution.
Develop a strategy and policy for market surveillance of consumer and industrial products, and start implementation as soon as possible.
Adopt and implement adequate framework legislation on general product safety and producers’ liability for defective products.
Introduce effective mechanisms to ensure food safety (balanced checks along the entire value chain and proactive market surveillance) without further delay. This process means, among other things, enacting legislation and training market inspectors in international and EU surveillance methodology and practice.
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References
BIPM (International Bureau of Weights and Measures). 2003. “Evolving Needs for Metrology in Trade, Industry, and Society and the Role of the BIPM.” BIPM, Paris.
EU (European Union). 2004. Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments.
GEPLAC (Georgian-European Policy and Legal Advice Centre). 2007. Georgian Economic Trends, October.
Government of Georgia (2010). Strategy in Standardisation, Accreditation, Conformity Assessment, Technical Regulation and Metrology and Programme on Legislative Reform and Adoption of Technical Regulations, Tbilisi, March 2010
Guasch, J.L. et al. 2007. Quality Systems ad Standards for a Competitive Age. The World Bank. Washington 2007.
IFC (International Finance Corporation) and World Bank. 2009. Doing Business 2010. Washington, DC: IFC and World Bank.
IFC (International Finance Corporation). 2009. “Georgia: Sector Competitiveness Overview—Identification of Most Promising Manufacturing Sectors and Priority Actions to Accelerate Investment and Growth: Preliminary Recommendations to Government of Georgia.” IFC, Tbilisi 2009.
IFC-MIGA (International Finance Corporation–Multilateral Investment Agency). 2009. Georgia: Sector Competitiveness Overview, Identification of Most Promising Manufacturing Sectors, and Priority Actions to Accelerate Investment and Growth: Presentation of Recommendations, IFC-MIGA, Tbilisi.
ISO (International Organization for Standardization)/UNIDO (United Nations Industrial Development Organization). 2009. Building Trust, The Conformity Assessment Toolbox. ISO: Genève 2009.
Kaarls, Robert. 2003. Evolving Needs for Metrology in Trade, Industry and society and the Role of the BIPM, BIPM: Paris, 2003
Kaarls, Robert. 2007. Evolving Needs for Metrology in Trade, Industry and society and the Role of the BIPM, BIPM: Paris, 2007
Kaarls, Robert. 2010. Evolving Needs for Metrology in Trade, Industry and Society. APMP 2010 Symposium on Global and Local Perspectives on Roles and Impacts of Metrology on Global Development and Challenges, November 17, 2010, Thailand
MacDonald, Mark, et al. 2002. Potential Economic Impact of the CIPM Mutual Recognition Arrangement, KPMG Consulting, April 2002
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Ministry of Economic Development of Georgia. 2009. Statistical Yearbook 2009, Tbilisi: Department of Statistics, Ministry of Economic Development of Georgia
Ministry of Economy of the Republic of Armenia. 2009. Armenia Economic Report 2009: From Crisis toward New Development, Ministry of Economy of the Republic of Armenia, Yerevan.
PTB (Physikalisch-Technische Bundesanstalt) and GeoSTM (Georgian National Agency for Standards, Technical Regulations, and Metrology). 2005. “MSTQ-Infrastructure in Georgia: Current Situation and Future Requirements. A Study.” PTB, Braunschweig; and GeoSTM, Tbilisi 2005.
PTB. 2006. Values and Rules for Global Responsibility. Quality Infrastructure: a Step Towards Good Governance. PTB: Braunschweig 2006
PTB. 2007. Quality Infrastructure. PTB: Braunschweig 2007
Sanetra y Mabán. 2007 The Answer to the Global Quality Challenge: A National Quality Infrastructure.
Swann, Peter. 2009. The Economics of Metrology and Measurement, Report for National Measurement Office, U.K. Department for Business, Innovation and Skills. London.
Tassey, Gregory. 2008.“Modeling and Measuring the Economic Roles of Technology Infrastructure.” In Economics of Innovations and New Technology 17 (7): 617–31.
UNDP (United Nations Development Programme). 2010. Human Development Report 2010. New York: UNDP.
World Economic Forum. 2010. Global Competitiveness Report 2010–2011. Geneva: World Economic Forum.
WTO. 2009. International Trade Statistics 2009, WTO: Geneva.
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Appendix A: Survey Questionnaires
Questionnaire for Companies Company:
Location (city, province):
Field of action (business area):
(Core) products:
Number of employees:
1. Your company produces basically for …
a)
Domestic market % Export % Both
b) If your company exports, to which regions of the world?
CIS states: Armenia, Azerbaijan, Ukraine
% EU states % United States % Other %
Observations and comments:
2. Is your company certified according to ISO 9001 / ISO 14000 / ISO 22000 / HACCP?
Yes acc. to........................... By whom? .................... Certificate is valid until when? (Please show us the certificate.)
in process intended not intended
3. What kind of quality assurance measures has your company implemented?
Receipt inspection (raw materials): No
In-process measurements: Yes No
Final inspections: Yes No
Others: please specify:
4. Who carries out the quality assurance / measurements?
Is there a quality management section? Yes No
If yes: a) Who is the quality manager?
b) Number of quality management staff. How many of them are directly involved in measurements?
c) Level of training and qualification of the personnel in quality management / metrology:
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d) Please estimate your company’s future personnel needs in quality management (total).
e) Please estimate your company’s future personnel needs in metrology only.
5. Does your company have available its own testing / calibration laboratory (in-house lab)? Yes No
If yes:
a) Which measuring instruments / working standards does your company have available? Please fill out the list.
Measuring instruments / standards Last calibration Range Uncertainty
b) Please specify the number of staff working in the laboratory and their level of qualification (if not yet answered in question 4).
6. Which and how many measuring instruments are in use in your company’s production processes
(apart from the lab)?
Please fill out the list.
Measuring instrument
Range Number Readability/ resolution
Date of last calibration
Available working standards
7. Do you know the uncertainty of your company’s measuring instruments? _________________
___________________________________________________________________________
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8. Has your company already made use of measuring / calibration services of the GEOSTM ? Yes No
9. Which metrology services does your company need?
a) In terms of calibration / verification? ______________________________________________________________________________________________________________________________________________________
b) In terms of training? ______________________________________________________________________________________________________________________________________________________
c) In terms of technical consulting? ______________________________________________________________________________________________________________________________________________________
d) How satisfied is your company with the services provided by GeoSTM/Metrology?
Excellent Satisfied Regular Unsatisfied
Quality
Time
Observations: _________________________________________________________________________________________________________________________________________________________________________________________________________________________________
10. Does your company apply standards? Yes No
a) If yes, which standards?
National Georgian Standards
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
MGS standards ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
ISO/IEC ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
CEN/CENELEC ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Other ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
b) How does your company purchase standards?
GeoSTM __________________________________________________________________________________________________
External (foreign) _______________________________________________________
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partners ___________________________________________
Other sources (please specify)
__________________________________________________________________________________________________
11. Are you a member of a Standards Committee of GeoSTM?
Yes No
a) If yes, which one?
___________________________________________________________________________ b) How do you judge the activities of the Standards Committee so far?
___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________
c) How satisfied are you with the work of the Standardization Department of GEOSTM?
Excellent Satisfied Regular Unsatisfied
Quality
Time
Observations: _________________________________________________________________________________________________________________________________________________________________________________________________________________________________
12. Are your company’s products subject to product certification (conformity assessment)? Yes No
a) Why does your company certify its products? Request by the client_________________________________________________ Other reasons________________________________________________________
b) Certification is done by which laboratory? _____________________________________________________________________________________________________________________________________
c) How satisfied is your company with the work of the laboratory in charge?
Excellent Satisfied Regular Unsatisfied
Quality
Time
Observations: _________________________________________________________________________________________________________________________________________________________________________________________________________________________________
d) Is it necessary for your company to get its products certified / assessed once again abroad? Yes No
If yes, why? ________________________________________________________________ ______________________________________________________________________________________________________________________________________________________
13. Which governmental requirements and inspections does your company submit to? 1)_________________________________________________________________________
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2)_________________________________________________________________________ 3)_________________________________________________________________________ 4)_________________________________________________________________________ 5)_________________________________________________________________________ 6)_________________________________________________________________________ ___________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________
14. Is your company organized in an entrepreneur’s Chamber of Commerce and Industry or/and
business associations? ______________________________________________________________________________________________________________________________________________________ If your company is a member,
a) Do the organizations offer services in quality matters? Yes No
b) If they do it, in which spheres?
Awareness and Information Activities
Consultancy
Training
15. What are the main obstacles for your company to be competitive in the domestic and foreign
markets? 1)_________________________________________________________________________ 2)_________________________________________________________________________ 3)_______________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________
16. Remarks and suggestions:
_________________________________________________________________________________________________________________________________________________________________________________________________________________________________ ___________________________________________________________________________ _________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Note: CEN = European Committee for Standardization; CENELEC = European Committee for Electrotechnical Standardization; GeoSTM = Georgian National Agency for Standards, Technical Regulations, and Metrology.
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Questionnaire for Laboratories (commercial and in-house) Laboratory:
Address (city, province):
Head of the laboratory:
Phone: E-mail:
1. What is your laboratory’s field of activity?
Verification of measuring devices as legal task
Calibration of measuring devices on behalf of the industry
Testing of products for conformity with defined requirements
Other (please specify):
2. In which countries are your laboratory’s test results / certifications recognized?
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
3. Who are your laboratory’s customers and in which branch are they engaged?
Names of important customers: (in the order of their importance)
Branch:
Mechanical engineering Calibration / testing laboratories
Textile industry Pharmaceutical industry
Petrol industry Chemical industry
Metallurgy Health care (e.g., hospitals)
Aluminum industry Tourism
Energy production Construction
Agriculture/agro-processing Services
Food / beverage industry Other (Please specify):
Retail market
4. Does your laboratory have a Quality Management System implemented? Yes
No If yes, according to which standard?
ISO 9001 Certified? Yes No
ISO / IEC 17025 Accredited? Yes (by: ) No
for the following scope /
applications:
Other (please specify):
If no, is certification / accreditation planned? Please comment:
5. If YES, we would like to ask you to answer the following questions:
a) What was/were the reason(s) for the accreditation?
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1)_____________________________________________________________________________ 2)_____________________________________________________________________________ 3)______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
b) Did your laboratory get any consultancy service for preparing the accreditation? Yes No If yes, from whom?___________________________________________________________
c) What were the main difficulties in the accreditation process? 1)_______________________________________________________________________ 2)________________________________________________________________________ 3)________________________________________________________________________ _________________________________________________________________________________________________________________________________________________________________________________________________________________________________
d) How does your laboratory evaluate the accreditation process?
Excellent Good Regular Indifferent
Time
Competence of the accreditation team
e) Is there any influence in your laboratory’s activity?
Yes Equal No
Increase in contracts
Increase in income
Improvement in the competence of your laboratory
6. Which type of services does your laboratory receive from GeoSTM/Metrology?
Yes No Please specify:
Verification
Calibration
Training
Consultancy
If yes, how do you estimate?
Excellent Good Regular Indifferent
Time
Quality
Competence of the personnel
7. What are the calibration services that you need urgently, but cannot be offered by GeoSTM?
(Please prioritize.) 1)____________________________________________________________________________ 2)____________________________________________________________________________ 3)____________________________________________________________________________ 4)____________________________________________________________________________ 5)____________________________________________________________________________ 6)____________________________________________________________________________ _________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
8. Please specify the personnel structure of your laboratory: Total number of staff:
Qualification / degree Number Average salary (optional)
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Scientists and engineers
Of those, how many are PhDs?
Technical staff
Administrative staff
Age structure Number Average salary (optional)
under 30 years
30–40 years
40–50 years
over 50 years
9. How is your laboratory financed?
Form of financing Amount Percentage
Governmental benefit
Income from services
Calibration / testing / verification
Training
Consultation
Other (please specify):
International projects
Other third-party funds
Total
10. Does your laboratory have a tariff / price list? Yes No
If yes:
a) By whom it was established?
b) By whom it was confirmed (if necessary)?
c) How have the fees have been determined? Which expenditures have been considered? work expended per measurement
administrative expenditure
capital investment for the laboratory
standing operating expenses for the laboratory
d) If applicable, can your laboratory provide a tariff / price list?
11. How many calibrations / tests / verifications were carried out last year by your laboratory?
Measurement / Category Type of service (calibration, testing, verification)
Number
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12. Are there customer demands that your laboratory cannot meet?
Yes No
a) If yes, which? (verification, calibration, and/or testing services)
b) What do you do if your laboratory cannot meet the demands of costumers? ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 13. Please specify and evaluate your laboratory infrastructure.
Air conditioning installed and functioning? Yes No
If yes: Temperature / temperaturerange:
Control limits temperature:
Relative humidity:
Control limits relative humidity:
If no: Do the normally existing environmental conditions allow competent measurements?
Yes, always Not always No
Is there enough work space to carry out the measurements? Yes No
Do the technical installations (e.g., electrical installations, light, etc.) meet the needs?
Yes No
Are there negative external influences to measurements, e. g. due to: vibrations noise high temperatures / heat low temperatures / cold dust radiation electric smog other:
Is the electric power supply permanently available? Yes No
If no: a) How many power blackouts (days, average)?
b) Is emergency power supply available? Yes No
c) Is it sufficient? Yes No
Is system voltage sufficiently stable? Yes No
What is location of the laboratory? (basement, ground floor, other)
Windows (number, direction, sun protection, other)
14. Did you participate in interlaboratory comparisons? Yes No
If yes, in which?
Measurement Range Institutions Date Remarks
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15. What services does your laboratory expect from
a) GeoSTM in the case of metrology? _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
b) GeoSTM in the case of standardization? _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
c) GAC in the case of accreditation? _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
16. What equipment does your laboratory have available?
Please fill out the list.
Equipment Range Resolution / readability)
Date of last calibration
Calibrated by
17. Are there plans to extend the activities to new fields of testing / calibration? Yes No
If yes, in which fields? 1)____________________________________________________________________________ 2)____________________________________________________________________________ 3)____________________________________________________________________________ ____________________________________________________________________________________________________________________________________________________________
18. What type of new equipment does your laboratory plan to install in the next three to five years? Please fill out the list.
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Equipment Range Resolution / readability
Further comments:
Note: GeoSTM = Georgian National Agency for Standards, Technical Regulations, and Metrology
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Appendix B: Additional Information on the Laboratory and Enterprise Survey
Laboratory survey The distribution of the surveyed laboratories was as follows:
Forty-one accredited laboratories participated. Of this number, only two accredited laboratories completed questionnaires electronically; almost all accredited laboratories were visited and interviewed on site.
Thirty-six nonaccredited commercial and company in-house laboratories were surveyed.
Of the 41 accredited laboratories, 18 were companies’ in-house laboratories.
Two laboratories did not respond to the inquiry.
One laboratory refused to participate in the survey.
The laboratory survey response rate was 96 percent.
The location of the laboratories is shown in Figure 15.
Figure 15: Geographical Distribution of Accredited Laboratories
Kutaisi5% Batumi
11%
Rustavi5%
Zestaponi3%
Tbilisi76%
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Figure 16: Customers of the surveyed laboratories
The 18 accredited in-house laboratories operate in the following sectors:
Pharmaceuticals
Mechanical engineering
Electrical measurement or testing
Calibration of electrical appliances
Chemical industry
Construction
Energy production
Mineral water extraction and bottling
Oil and gas Most of the laboratories were selected from a list provided by the Georgian Accreditation Center (GAC), except for the nonaccredited in-house laboratories.
0
2
4
6
8
10
12
14
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Figure 17: Age Distribution of Personnel in Surveyed Laboratories
Enterprise Survey The methodology for obtaining the information included visiting and interviewing company representatives as well as electronically distributing questionnaires:
Interviewers visited 101 companies.
Electronic questionnaires were sent to 40 companies, of which 16 responded.
Thirty-four companies refused to respond, are not currently operational, or had other reasons for not responding to the survey.
Figure 18: Surveyed Companies Response Rates
under 30
years,
15%
30–40 years,
36%40–50 years,
28%
above 50
years,
21%
67%
14%
19%
Visited&Responded
Did not Respond
Refused/Other reasons
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Appendix C: Decree on the Establishment of the National Quality Council
MINISTRY OF ECONOMIC DEVELOPMENT OF GEORGIA DECREE N 1- 1/2347 19.10.2009 Tbilisi On Establishment of National Quality Council To Improve the Effectiveness of Quality Infrastructure System In order to incorporate Georgia into global economic practices and promote the development of the National Quality Infrastructure (QI – standardization, metrology, testing, compliance audit, certification and accreditation) in compliance with the international requirements concerned and based on Provision 20 of Article 5 of the “Law of Georgia on the Structure, Terms of Reference and Activities of the Government of Georgia”, I, hereby, order:
1. To establish the National Quality Council. 2. To approve 2.1. The Statute of the National Quality Council (Annex 1); 2.2. The Members of the National Quality Council (Annex 2); 3. The Decree becomes effective immediately upon signing.
Zurab Pololikashvili Minister
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Annex 1 Approved by Decree N__________ dated ________2009 of the Minister of Economic Development of Georgia The Statute of the National Quality Council Article 1. General Provisions
1. The National Quality Council (hereinafter referred to as The Council) is an advisory body of the Minister of Economic Development of Georgia
2. The Council acts in accordance with the Georgian legislative acts, subordinate legislation and the present Statute.
Article 2. Objectives of the Council
1. The Council’s objective is to support the sustainable development of the National Quality Infrastructure in accordance with internationally agreed parameters, to study the existing environment, to identify problems, to define priorities, and to develop proper substantiation and recommendations.
Article 3. Functions of the Council
1. To promote the importance of the National Quality Infrastructure, to support regular interaction and partnership with non-governmental organizations, government agencies, international institutions and private sector.
2. To study the current situation in regard to the quality infrastructure system and develop the periodic reports.
3. To prepare and submit recommendations to the Minister of Economic Development. The recommendations will be developed in the following directions: a) Define the general priorities for the development of the quality infrastructure
system; b) Support the increase of the reliability of the elements of the national quality
infrastructure and their recognisability; c) Support the promotion and competitiveness of the Georgian products; d) Provide all the interested stakeholders with information on the elements of
the national and international quality infrastructure; e) Support the consumers’ rights protection; f) Support the fulfilment of obligations under the international agreements in
the field of quality infrastructure system. 4. To develop recommendations for setting up a system of skills trainings/
upgrading for the experts/ specialists involved in quality infrastructure system.
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Article 4. Organizational Structure of the Council. Members of the Council and Performance of Activities.
1. The organizational structure of the Council: a) The Council is chaired by the Minister of Economic Development; b) Should the Minister be absent, the functions of the Council’s Chairman
will be assigned to the Deputy Minister of Economic Development or to the Council’s Speaker to be elected by the Council at the first meeting of the Council members;
c) To ensure the efficiency of the activities within the scope of the Council’s operations, the Council will establish the Permanent Secretariat. The functions of the Permanent Secretariat will be performed by one of the Ministry’s organization departments or by one of the agencies under the Ministry as defined by the Minister’s Decree.
2) The Members of the Council:
a) The Council is composed of the representatives of the government agencies, governmental subdivisions, independent experts, non-governmental organizations, business associations and private sector;
b) Should the particular issue require the participation of non-member experts, the Council will invite them upon the Council’s respective decision;
c) The Council will advise the Council’s Chairman about the changes in the composition of the Council.
3) Performance of Activities:
a) To ensure the efficiency of the activities within the scope of the Council’s operations, the Council will develop an internal methodological manual;
b) The Council proceedings are valid if half of its members are present or represented;
c) The Council’s decision is made by a majority of votes. If there is a tie vote, the Chairman or other person presiding at the meeting has the casting vote;
d) The minutes of the Council meeting are considered as an official record of the proceedings of a meeting to be signed by all the Council members that attend the meeting;
4) The Council will terminate its operations and will make amendments to the
Statute in conformity with the rules established by the Georgian legislation.
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Annex 2 The Members of the National Quality Council
1. Zurab Pololikashvili - - Minister of Economic Development of Georgia 2. Zurab Alavidze – Deputy Minister of Economic Development of Georgia 3. Lali Gogoberidze – Head of the Department of Economic Analysis and Policy,
Ministry of Economic Development of Georgia 4. Tsismani Tsabadze – Deputy Head of the Department of Economic Analysis and
Policy, Ministry of Economic Development of Georgia 5. Irakli Matkava – Head of Department for Foreign Trade and International
Economic Relations, Ministry of Economic Development of Georgia 6. Marina Macharashvili – Head of Division for Foreign Trade at the Department for
Foreign Trade and International Economic Relations, Ministry of Economic Development of Georgia
7. Nodar Khatiashvili – General Director of the Georgian National Agency for Standards, Technical Regulations and Metrology
8. Alexander Borokhovin – Head of Standards Department, the Georgian National Agency for Standards, Technical Regulations and Metrology
9. Nino Mikanadze – Head of Administrative Department, Georgian National Agency for Standards, Technical Regulations and Metrology
10. Paata Gogolidze – General Director of the National Accreditation Body – Accreditation Center
11. Malkhaz Kharebava – Deputy Director of the National Accreditation Body – Accreditation Center
12. Archil Nikolaishvili – Deputy Minister of Energy of Georgia 13. Temur Pirvelashvili – Deputy Head of the Health Care State Regulation Agency,
Ministry of Labor, Health and Social Affairs of Georgia 14. Ketevan Laperashvili – Head of Division for Food Safety and Risks Analysis,
Ministry of Agriculture of Georgia 15. Paata Chipashvili – Head of Integrated Management Department, Ministry of
Environment Protection and Natural Resources of Georgia 16. Mikheil Gvatua – Leading Specialist of the Economic Division under the
Regional Development Department, Ministry of Regional Development and Infrastructure of Georgia
17. Irma Kavtaradze – Member of the Georgian National Energy and Water Supply Regulatory Commission
18. Ekaterine Oshkhereli – Deputy Executive Director of the Georgian National Energy and Water Supply Regulatory Commission
19. Revaz Svanidze – Expert of the Department of Strategic Development and Competitiveness, Georgian National Communications Regulatory Commission. (Doctor of Technical Sciences, Professor)
20. Giorgi Tatishvili – Deputy Head of the National Agency for Oil and Gas 21. Omar Kereselidze – President of the National Center for Production, Monitoring
and Scientific Research of Ecologically Clean and Genetically Modified Products, Academician of the Georgian Academy of Sciences
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22. Madona Koidze – Chairman of the Georgian Consumers’ Association 23. Revaz Kobakhidze – Deputy Chairman of the Georgian Consumers’ Association 24. Giorgi Kotrikadze – Georgian Association of Oil Importers and Distributors’ Rights
Protection “Nia” 25. Elguja Meladze – Chairman of the Employers’ Association of Georgia 26. Giorgi Datukishvili – Executive Director of the Georgian Pharmaceutical Company
“GMP” 27. Nino Manvelidze - Test Lab Quality Manager at the “Wine Laboratory” Ltd 28. Levan Nanobashvili – “Metrologi” Ltd
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Appendix D: Structure of the GeoSTM NMI
Structure of the NMI and Distribution of Personnel, June 1, 2010
Department, division, or laboratory
Number of staff
Financed by state budget
Financed by laboratory
income
Total
Office of the Director of Metrology 3 - 3
Laboratory of Mechanical Magnitudes 7 4 11
Laboratory of Electrical Magnitudes 7 - 7
Laboratory of Radiophysics, Optics, and Acoustics
4 1 5
Laboratory of Physical-Chemical Magnitudes
8 1 9
Laboratory of Dimensional Measurements
2 - 2
Verification Service (including Time and Frequency)
3 1 4
Training Center - 2 2
Batumi Laboratory of High Voltage - 1 1
Kolkheti Center of Climate Tests - 1 1
Total 34 11 45
Source: GeoSTM.
Qualifications of the NMI Staff, May 3, 2010
Position Budget Nonbudget Total
Amount Of those, the number of
PhDs (1)
Amount Of those, the number of
PhDs (1)
Amount Of those, the number of
PhDs (1)
Administrator 3 1 - 3 1
Head of Laboratories
6 5 - 6 5
Head of Service
1 1 - 1 1
Head of Center
- - 1 1 1 1
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Lead Specialist
13 4 - 13 4
Specialist 32 6 11 2 43 8
Total 55 17 12 3 67 20
Source: GeoSTM Note: (1) Includes candidates and doctors of science.
