Pursuing ISO accreditation Section 3: Recommendations for the implementation of the QMS Quality Management in Calibration, Maintenance and Repair of Instrumentation 36 3 SECTION 3: RECOMMENDATIONS FOR THE IMPLEMENTATION OF THE QMS This section will provide you recommendations for the implementation of your Quality Management System. Further, Section 4 will supply the templates of QM documentation that you can adapt to your specifics. Considering that Electronics Laboratories often provide electrical calibration services, we propose you a QMS structure following a combination of the recommendations from ISO 17025:2005 and ISO 9001:2000 guides. 3.1 MAIN ACTIONS FOR QMS IMPLEMENTATION According to the ISO 9001:2000 recommendations, for the implementation of the QMS, your organization shall: • Identify the scope of its QMS, as well as the normative references it complies with. • Identify the processes needed for its quality management system and their application. • Determine the sequence and interaction of such processes. • Establish criteria and methods needed to ensure that the operation and the control of such processes are effective. • Ensure the availability of resources and information necessary to support the operation and monitoring of these processes. • Monitor, measure and analyze the results of these processes. • Implement actions aimed to achieve the planned results and to seek continual improvement of the system. 3.2 DEFINING THE SCOPE OF THE QMS The scope of the Quality Management System is the provision of some of the following services: o the repair and maintenance of electronic equipment, o the electrical calibration of testing equipment and nuclear instruments, o the design and development of interfaces/adaptors for scientific equipment and instruments not available commercially IT IS ADVISABLE THAT YOU DECLARE IN YOUR QUALITY MANUAL EXPLICITLY THAT THE IMPLEMENTATION OF YOUR SYSTEM HAS BEEN PERFORMED THROUGH ADOPTING GENERAL PROCEDURES TO ENSURE CONSISTENCY IN OVERALL SYSTEM OPERATION. 3.3 NORMATIVE REFERENCES TO FOLLOW The Quality Management System shall comply to the requirements of the following: • ISO 9000:2005 – Quality Management Systems: Fundamentals and vocabulary. • ISO 9001:2000 – Quality Management Systems: Requirements. • ISO/IEC 17025:2005 - General requirements for the competence of testing & calibration laboratories.
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Pursuing ISO accreditation Section 3: Recommendations for the implementation of the QMS
Quality Management in Calibration, Maintenance and Repair of Instrumentation 36
3 SECTION 3: RECOMMENDATIONS FOR THE IMPLEMENTATION OF
THE QMS
This section will provide you recommendations for the implementation of your Quality Management System. Further, Section 4 will supply the templates of QM documentation that you can adapt to your specifics. Considering that Electronics Laboratories often provide electrical calibration services, we propose you a QMS structure following a combination of the recommendations from ISO 17025:2005 and ISO 9001:2000 guides.
3.1 MAIN ACTIONS FOR QMS IMPLEMENTATION
According to the ISO 9001:2000 recommendations, for the implementation of the QMS, your organization shall:
• Identify the scope of its QMS, as well as the normative references it complies with. • Identify the processes needed for its quality management system and their application. • Determine the sequence and interaction of such processes. • Establish criteria and methods needed to ensure that the operation and the control of
such processes are effective. • Ensure the availability of resources and information necessary to support the operation
and monitoring of these processes. • Monitor, measure and analyze the results of these processes. • Implement actions aimed to achieve the planned results and to seek continual
improvement of the system.
3.2 DEFINING THE SCOPE OF THE QMS
The scope of the Quality Management System is the provision of some of the following services:
o the repair and maintenance of electronic equipment, o the electrical calibration of testing equipment and nuclear instruments, o the design and development of interfaces/adaptors for scientific equipment
and instruments not available commercially
IT IS ADVISABLE THAT YOU DECLARE IN YOUR QUALITY MANUAL EXPLICITLY THAT THE IMPLEMENTATION OF YOUR SYSTEM HAS BEEN PERFORMED THROUGH ADOPTING GENERAL PROCEDURES TO ENSURE CONSISTENCY IN OVERALL SYSTEM OPERATION.
3.3 NORMATIVE REFERENCES TO FOLLOW
The Quality Management System shall comply to the requirements of the following:
• ISO 9000:2005 – Quality Management Systems: Fundamentals and vocabulary.
• ISO 9001:2000 – Quality Management Systems: Requirements. • ISO/IEC 17025:2005 - General requirements for the competence of testing &
calibration laboratories.
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3.4 DEFINING THE ORGANIZATIONAL STRUCTURE
A relation of the authorities and subordination chain from the highest levels of the parent organization (if any) must be described and stated. A typical structure diagram for a public organization could be:
3.4.1 DEFINING THE ORGANIZATIONAL RESPONSIBILITIES
The responsibilities and authorities of the members of the organization in relation to the Quality Management System shall be defined. A typical structure could be:
3.5 DEFINING THE MISSION STATEMENT
The organization mission shall be clearly declared. If the organization is subordinated to a parent organization, the mission shall be declared as to comprise
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from general (parent organization) to the particular (organization) mission statement.
As an example, the mission of the Electronics Group of the IAEA Laboratories is provided: The IAEA is seeking to accelerate and enlarge the contribution of atomic energy to peace, health and prosperity throughout the world. The Agency shall encourage and assist research and make provisions for materials, services, equipment and facilities to meet the needs of its Member States. The Agency shall establish, apply and administer international safeguards designed to ensure, within its abilities, that special fissionable and other materials, services, facilities, equipment and information are only used for peaceful purposes. Within this context, the Mission of the Agency's Laboratories at Seibersdorf and Vienna is: IN THE FIELD OF INTERNATIONAL SAFEGUARDS: to provide analytical data and services, in support of Agency inspections, which ensure the credibility of the operation of international safeguards and the monitoring in compliance with the signatories of the Safeguards Agreements to the commitments made to the Agency and the International Community; IN THE FIELD OF NUCLEAR SCIENCE, TECHNOLOGIES AND THEIR APPLICATIONS: through technology transfer, services and research, to contribute to the implementation of the Agency's programmes on sustainable development by the effective use of nuclear sciences in monitoring of the environment, food and agriculture, human health, industry, physical and chemical sciences, and the management of water resources. In particular, the main mission of the Electronics Group is focussed on assisting Member States in the design, maintenance and repair of nuclear instrumentation and scientific equipment in general. The group accomplishes this mission by supporting and participating in activities organized by IAEA Technical Co-operation including conducting and supporting training courses at Seibersdorf and in Member States. The EG provides technical advice and repair services for Member States and other IAEA units, as well as designs and develops interfaces/adaptors for scientific equipment and Instruments not available commercially and which are requested by the IAEA or Member States. All these activities require the provision of reliable electrical calibrations of testing equipment and nuclear instruments, in order to contribute to improve the quality of the work performed in the laboratories of the IAEA and the Member States
3.6 DEFINING THE QUALITY POLICY A typical declaration of the Quality Policy might be: "It is the policy of the ORGANIZATION that its service support achieves a level of quality in execution and delivery of results that is commensurate with the requirements of its quality system. The ORGANIZATION will endeavour to carry out electrical calibration of testing equipment and nuclear instruments and provide results that are at a quality level consistent with the international requirements.
To achieve this, the ORGANIZATION will establish a Quality System in compliance with the ISO/IEC 17025:2005 and the ISO 9001 standards. The Organization Leader will ensure that all the members of the staff will be acquainted with the Quality System and the implemented procedures. The members of the ORGANIZATION will perform their work as to fulfil the requirements of the Quality Policy and will remain free of any kind of commitments or motivations other than those explicitly declared by the (PARENT, if any) ORGANIZATION."
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3.7 DECLARING THE QUALITY OBJECTIVES
Typical Quality objectives might be:
1. To ensure that the management of the ORGANIZATION and the service support provided to its customers are maintained and performed in accordance with the principles of a quality system established in compliance with ISO/IEC 17025:2005 and ISO 9001:2000;
COMPLIANCE TO THIS STANDARD IS ONLY REQUIRED FOR THE QMS INCLUDING IN ITS SCOPE THE PROVISION OF ELECTRICAL CALIBRATION SERVICES
2. To ensure that the calibration measurements are made following validated calibration instructions and that the provided electrical calibration results are traceable to SI units and comply to ISO/IEC 17025:2005.
3. To ensure that all the repair/maintenance services are performed following established and validated procedures agreed to by its customers, and in compliance with the ISO 9001:2000;
4. To ensure that all staff members involved in activities within the scope of the quality management system are aware of the quality policy, its documentation and implementation, and continuously evaluate opportunities for improving the group’s performance;
5. To provide the ORGANIZATION personnel with a stimulating and rewarding environment; and
6. To achieve these objectives in a safe, efficient and effective manner.
NOTICE THAT OBJECTIVES A) TO C) CAN BE DEFINED DEPENDING ON THE SPECIFICS OF YOUR WORK. ON THE CONTRARY OBJECTIVES D) TO F) ARE OF OBLIGATORY INCLUSION!
3.8 DECLARING THE QUALITY COMMITMENT
The declaration can be enunciated as:
o The ORGANIZATION is committed to achieve the above enunciated objectives through the implementation of a quality system structured to address, as applicable, the criteria given in international standards of the ISO/IEC 17025:2005, the ISO 9001 and other relevant international standards and guides. The quality system shall be further developed to meet international best practice in activities carried out.
o The ORGANIZATION management at all hierarchical levels, hereby represented by the Organization Leader, is fully committed to endorsing the quality policy, to achieving the quality objectives and to implementing the quality system. Overall responsibility for the implementation of the quality system resides with the Organization Leader supported by a proper quality organisational structure.
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3.9 STRUCTURE OF THE QMS
The Quality Management System shall include the following key elements:
• A Quality Manual. • A system for keeping documented and validated calibration instructions, well
documented operational procedures and corresponding records. • Instrumentation that is periodically calibrated and checked to ensure traceability of the
calibration results and the quality of the maintenance/repair services. • A clear and comprehensive statement of uncertainty in the measured quantities and in
the reported values resulting from the electrical calibrations.
3.10 STRUCTURE OF THE QMS DOCUMENTATION
NOTICE THAT DOCUMENTATION MUST BE UNAMBIGUOUSLY AND CLEARLY CODED FOR PROPER IDENTIFICATION.
3.10.1 THE QUALITY MANUAL The Quality Manual shall relate:
o the scope of the Quality Management System. o the statements of quality commitment, quality policy and quality objectives. o a list of responsibilities and authorities in regard to QMS. o the different procedures established for quality management, or a reference to
them. The latter allows to prepare a less voluminous QM. o the interaction between the processes of the QMS.
3.10.2 THE QUALITY MANUAL STRUCTURE It is advisable to arrange the contents of the Quality Manual following the contents outline of the chosen ISO Standard to comply with (ISO 9001 or ISO/IEC 17025).
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The ISO/IEC 17025 outline provides a thorough and easy readable drawing-up. The addition of some sections to this outline is a practical choice to ensure compliance to both standards in an easy way. A template of QM is provided in Section 4 for your consideration.
3.11 A MASTER LIST OF GENERAL OPERATIONAL PROCEDURES
The following table comprises a list of procedures that are needed to ensure the harmonic functioning of the quality management system and to establish the inter-relation between some of its components:
3.11.1 FORMAT FOR PROCEDURES, INSTRUCTIONS AND FORMS
The reasons for establishing a standard format are:
• It is beneficial to the user who learns to look for information in set places. • It acts as a check list for the person who prepares the procedure or instruction. • It makes the use of different forms related to the Quality Management System more
transparent and allows the use of cross references. • To maintain the standard format and to minimize the hazard for requirements to be
overlooked. • To make clear the status of a current document (approval date and current version).
3.11.2 APPROVAL, REVISION, CONTROL AND DISTRIBUTION OF QUALITY DOCUMENTATION
This procedure establishes the authorities for the approval, dissemination, revision and changes in the quality documentation. In principle, the documentation must be prepared by the technical staff responsible for the process to which the given
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procedure or document is related with. Major revision shall be performed by the Technical Manager or the Quality Manager, as appropriate.
For example: Procedures and records related to workflow control and IQC must be reviewed by the QM, whereas technical procedures must be reviewed by the Technical Manager.
All the documentation must be approved by the top manager of the organization.
ORIGINALS OF THE QUALITY DOCUMENTATION MUST BE KEPT IN A SAFE PLACE. AUTHORISED COPIES OF PROCEDURES SHALL BE AVAILABLE IN THE WORKPLACES FOR THE USE OF THE STAFF INVOLVED IN EACH PARTICULAR PROCEDURE.
3.11.3 ORGANIZATION OF INTERNAL AUDITS
This procedure shall describe the basic internal audit practices, and provide guidelines for establishing, planning, carrying out and documenting internal audits. Responsibilities, time frame, and operations to be taken as part of the audit shall be defined, as well as the outputs of the audits and their interrelation with management actions.
The Quality Manager shall control the accomplishment of the plan of audits and to participate in all of the activities related with the audits. The technical manager and the top management shall design the remediation plans and to make them effective in realization.
3.11.4 HANDLING CUSTOMER COMPLAINTS
The purpose of this procedure is to allow a proper response to the customer's complains, to provide the evidence on corrective and preventive actions undertaken and to allow management review and related process and quality system improvements.
Top management is responsible for ensuring that the causes of the complaints are thoroughly investigated, proper actions planned and realized in due time.
ANY POTENTIAL NONCONFORMITY REVEALED BY ANY MEMBER OF THE STAFF SHALL BE TREATED AS A COMPLAINT.
3.11.5 PROCUREMENT OF GOODS AND SERVICES
The conditions to ensure that components, supplies and instruments are purchased from credited suppliers (or at least from suppliers ensuring the compliance to requirements) must be established and maintained.
Whenever possible, the services shall be subcontracted from accredited providers. However, in many cases such condition can not be met, but in that case, the quality of the purchased services must me ensured.
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3.11.6 RECEPTION AND STORAGE OF GOODS
The required actions to ensure that the quality of the acquired goods is verified upon receipt must be established. The storage of the goods must follow logic classification rules, and records must be kept updated on the existing amounts and current conditions.
If suitable software is not available to keep highly automated electronic records, at least hard copies shall be maintained. Is better to have a simple system for control than having none!
3.12 A MASTER LIST OF SPECIFIC OPERATIONAL PROCEDURES FOR ELECTRONICS
PRACTICE
Some procedures related to the specific case of electronic practice that have to be implemented are:
3.12.1 DEFINITION OF WORKING ASSIGNMENTS AND MONITORING THE SERVICE FLOW
As mentioned before, the rich degree of diversity found in instruments design and performance imposes the risks of changes in any a-priori defined requirements for electronic services. Keeping a constant communication with the customer is the only way to pursue agreement in regard to any modifications or changes arising from unexpected findings. Be always sure that:
• the laboratory has the capability to perform the modified task. • an agreement is reached with the customer before to proceed.
ON A LONG TERM, IT IS ALWAYS PREFERABLE TO REFUSE A SERVICE REQUEST, RATHER THAN TO FAIL TO CUSTOMER EXPECTATIONS.
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3.12.2 A GENERAL WORKFLOW CHART
3.12.3 INTERNAL QUALITY CONTROL PRACTICE
Internal Quality Control involves the practical steps undertaken to ensure that the results of the work are of a degree of quality that satisfies the customer expectations.
In repair/maintenance works the level of quality in the ideal case is the restoration of instrument performance to comply with supplier specifications. However, the necessary infrastructure to verify the instrument performance is not always available, or some components of the instrument may have had deterioration due to use (e.g. lose of resolution of a detector due to detector crystal ageing). In that case the level of quality shall be agreed in advance with the customer. In electrical calibrations the quality control is aimed to ensure that the uncertainties in calibration results are of a magnitude appropriate for the use to which the calibrated instrument is intended.
3.12.4 STATISTICAL CONTROL IN IQC PRACTICE
The interpretation of the results of IQC measurements depends on the concept of statistical control, which corresponds with stability of operation.
Precision and trueness of calibration results must be assessed. Precision is the spread of replicate results whereas trueness is the closeness of agreement of their mean value to the reference value.
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3.12.5 ELECTRONIC REPAIR
The scope and extent of electronic repair/maintenance works are difficult to generalize. The rich degree of diversity found in instruments design and performance does not allow to establish a clear a-priori defined statements. However, some general principles and set of actions can be outlined in advance to achieve the maximal customer satisfaction and to avoid conflicts in work assignment realization:
• verifying that something is really wrong (troubleshooting). • identifying and locating the cause(s) of the trouble. • fixing the trouble and repairing the system. • verifying that the trouble has been corrected. • follow up to prevent future trouble.
3.12.6 ELECTRICAL CALIBRATION
Electrical calibration implies that the results from a device measuring an electric magnitude with unknown accuracy are compared with the values provided for a device (calibrator) whose uncertainty is known. This calibrator is universally accepted as "reference" and traceable to international standards. The main actions in electrical calibration are:
• assessment of calibration capability. • switching on and stabilizing the instrument under calibration. • instrument initial verification and troubleshooting. • setting operational parameters and interconnection. • calibrator adjustment. • calibrator control. • calibration measurements. • quantification of the uncertainty of the results. • reporting the results and issuing a calibration certificate.
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3.12.7 UNCERTAINTY ESTIMATION
Uncertainty is a parameter associated with the result of a measurement that characterises the dispersion of the values that could be reasonably attributed to the measurand.
Electrical calibration implies that the results from a device measuring an electric magnitude with unknown accuracy are compared with the values provided for a device (calibrator) whose uncertainty is known. This calibrator is universally accepted as "reference" and traceable to international standards. Calibration records any deviations from this reference and when it is possible corrects it.
3.12.7.1 TYPE A EVALUATION
Type A evaluation of standard uncertainty can be applied when several independent observations can be made for one of the input quantities under the same conditions of measurement. If there is enough resolution in the measurement process there will be an observable scatter or spread in the values obtained.
3.12.7.2 TYPE B EVALUATION
Type B evaluation of standard uncertainty is the evaluation of the uncertainty associate with an estimate Rix by means other than statistical analysis of a series of observations. The proper use of available information calls for insight based on experience and general practice. The standard uncertainty u(Rix) is evaluated by scientific judgement based on all available information on the possible variability of Rix. Such estimation can be derived from:
• Previous measurement data. • Experience with or general knowledge of the behaviour and properties of the
instruments. • Manufacturer's specifications. • Data provided in external calibration and other certificates. • Uncertainties associated to reference values taken from databases.
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The measurand in electrical calibration is the indication (Rx) of the device under calibration for the measured magnitude R. The input quantities are the n replicate readings from the device under calibration (Rix) and the reference value of the calibrator (RC).
A general expression for the indication in direct measurements can be defined as:
3.12.7.4 EXAMPLE: UNCERTAINTY ESTIMATION IN THE CALIBRATION OF A DIGITAL
MULTIMETER
A DMM with a reading resolution of 10-5 and a relative uncertainty of reading of < 10-4 is calibrated at an input of 10 V DC using a Calibrator as a reference standard.
Each i reading indication Vi and its uncertainty u(Vi) can be described as:
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The estimation of uncertainty in the event of indirect measurements (e.g. calibration of charge) shall be based in the model used for the quantification of the measurand from the input quantities:
CF – Calibration factor, qR – real charge, m – mean of replicate measurements, UR – reference DC voltage (supplied by calibrator) CR – reference capacitance
3.12.7.6 VALIDATION OF CALIBRATION INSTRUCTIONS
The purpose of this procedure is to define the set of procedures for the verification of the adequacy of the results obtained by using a calibration instruction adopted from a third party developer.
Validation shall include:
o Confirmation of identity and specificity. o Verification operations. o Calibration operations:
o Primary measurements. o Calibrator control. o Uncertainty estimation. o Report of results and calibration certificate. o Additional actuators verification.
