ACCREDITATION FOR CONFORMITY ASSESSMENT,

CALIBRATION AND GOOD LABORATORY PRACTICE BILL,

2006

1 November 2006

Structure of Presentation

• Background and context - South African and Global Technical Infrastructure

• International practice in accreditation• History of the National Accreditation system • Review of the National Accreditation system • Purpose of bill – Need for change• What does the SANAS do? - Mandate• Process thus far & Parties Consulted• Financial, Personnel and Organisational Implications• Recommendations

Technical Infrastructure

• Globalisation is increasing the demands on countries to demonstrate that they have the technical infrastructure to guarantee that products originating in their territories are safe and ‘fit for purpose’.

• Technical infrastructure is required to meet the standards and measurement challenges required by health and safety considerations, environmental considerations (including climate change), as well as considerations of interoperability (necessary for globally dispersed manufacturing platforms).

• Institutions need to be maintained and improved in order to remain relevant as the platform for global economic efficiency and market access of products.

SOUTH AFRICA’S TECHNICAL INFRASTRUCTURE

CONFORMITY ASSESSMENTProve technical requirements are met

Testing, Inspection & CertificationSUPPLIER CUSTOMER

VOLUNTARY

SECTOR

Customer/Market

Requirements

REGULATORSAdminister regulations

REGULATED

SECTOR

GOVERNMENTSet policy, laws &

technical regulations

NMI- MEASUREMENTUnderpins testing & calibration

through national measurement standardsSANAS- ACCREDITATION

Assures competence

SABS- STANDARDSSpecific technical requirement

of a product or a system

Globalisation and Technical Infrastructure

SOUTH AFRICA

SADCMETEUROMET

APMP

SADCAEA

APLAC

SADCSTANCEN/CENELEC

PASCREGIONAL

INTERNATIONAL

Standardisation(ISO/IEC)

Accreditation(ILAC/IAF)

Metrology/BIPM)

SABS SANAS NMI

WTO TBT

International practice in accreditation

• The relationship between national accreditation bodies such as SANAS are governed through mutual recognition arrangements. This has enabled accredited conformity assessment services to achieve a form of international recognition. It has also allowed test data, certificates or inspection reports accompanying exported goods to be more readily accepted in overseas markets.

• This effectively reduces costs for both the manufacturer and importers, as it reduces or eliminates the need for products to be retested in another country.

International practice in accreditation - continue

• These MRAs were based on peer assessments by teams of experts. They assessed the competence of national accreditation bodies and their compliance with international codes of best practice.

• National accreditation bodies in turn use international agreed to standards such as ISO/IEC 17025, ISO/IEC 17020 and guides 61 and/or 62 for the accreditation of laboratories, inspection and certification bodies, respectively.

Practical examples

• The Department of Labour is a case in point. It has outsourced inspection services, such as fire extinguishers and vessels under pressure, and now uses SANAS accreditation to monitor the activity of its approved inspection service providers as part of managing local regulatory risk.

• In the voluntary sector, an increasing demand by large European based food retailers is for compliance to their own food production and safety standards. SANAS competence in the food area has been recognised by them. This means that in certain cases, local suppliers can use SANAS accredited certification bodies to prove compliance to these standards. This ensures that local produce complies with these standards prior to export and prevents the costs and unnecessary waste that could be incurred if such activity could only be performed at the port of entry.

History of National Accreditation System

• Established in 1994 by Cabinet.• Objective was to create a single national

accreditation body. • Both the private and the public sector. • SANAS represents South Africa internationally in

matters relating to accreditation, and in the broad area of international acceptance of conformity assessment.

History of National Accreditation system- continue

• It has achieved a high level of international recognition. South Africa, through SANAS, is a founder signatory of the global mutual recognition arrangements of both the ILAC and the IAF.

• SANAS is also a member of the regional accreditation body, called the Southern African Development Community Cooperation in Accreditation (SADCA). At present, SANAS provides essential regional accreditation support to the SADC region.

Review of National Accreditation System

• SANAS currently operates as ‘section 21 company and this create lack of ownership

• A critical issue is the strength of Government’s recognition of SANAS as the national accreditation authority

• Government to use SANAS accreditation in an effective and unified manner

• Bring SANAS in line with South African Technical Infrastructure counterparts, i.e. SABS

• To close user gaps in the public sector and to raise the profile of accreditation in the public sector

• To guarantee that government does not duplicate the structure.

The purpose of the Accreditation bill

• To provide an internationally recognised accreditation and GLP monitoring system for SA

• Establish SANAS as a Public entity

Need for an Independent entity

The change in the corporate form is neccesitated by the prescription of impartiality of the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) in order to maintain international recognition of SANAS.

Need for changing the status of SANAS

• Strengthening of Government’s recognition of SANAS as the national accreditation authority for calibration, conformity assessment and good laboratory practices;

• Maintenance of SANAS as an internationally recognised accreditation body as a crucial element of a well-functioning technical infrastructure;

• Government to use SANAS accreditation in an effective and unified manner.

• Enabling the dti’s to ensure strategic direction and alignment of SANAS and the rest of the technical infrastructure i.e. Standards and Metrology with national priorities isuch as ASGISA and the Industrial Policy

Need for changing the status of SANAS -continue

• This new identity is required to;• meet the requirements of National Treasury to

phase out section 21 companies as government agencies,

• have the SANAS Board appointed by the Minister of Trade and Industry , and

• establish an advisory Forum that will continue to ensure that stakeholder interests are communicated to and considered by the Board of Directors.

Mandate

• Provides for an independent process and assessment whereby the competence to perform a specific service of conformity assessment bodies are determined.

• Thus provides confidence in the competence and reliability of testing, inspection, certification service providers.

• Allows for the use of private sector bodies to operate in the regulatory domain, freeing up government resources for other priority areas.

Mandate -continue

To provide accreditation services whereby they formally regulate the technical competency of conformity assessment service providers that offer testing and certification services in both the public and private sector.

 

Objectives

• Accredit or monitor for GLP compliance purposes, organisations falling within its scope of activity subject to them complying with relevant criteria;

• Promote accreditation as a means of facilitating international trade and enhancing South Africa’s economic performance and transformation;

• Promote the competence and equivalence of accredited bodies; and

• Promote the competence and equivalence of compliant GLP facilities.

 

Accreditation and Conformity Assessment

Accreditation

Certification body

Inspection body

 Testing laboratory

Product/ service

Producer

Consumer WTO +Regions+Nat Government

Requirements

Market

Demands for accreditation

Conformity assessment

Process thus far• FRIDGE Study on Standards, Quality Assurance,

Accreditation and Metrology (SQAM) completed April 2001 - benchmarked against Brazil, Australia, UK and Malaysia.

• Cabinet approved project for restructuring of Technical Infrastructure on 22 May 2002.

• the dti Policy on Modernising the South African Technical Infrastructure approved June 2004.

• Workshops held with government departments and industry on policy position July 2004.

• This was supplemented by letters to DGs of various departments – August 2004.

• Written comments solicited from all stakeholders until September 2004.

• Nedlac Task Team concluded report on policy proposals October 2004.

Process thus far - continue

• Lawyers appointed to draft bills – March 2005• Consultation with Nedlac, Institutions and dti Legal Directorate

on draft bill completed and inputs incorporated – April 2006.• Cabinet Committee on Governance and Administration on 1

August 2006 recommended the approval of the following recommendations by Cabinet:- The introduction of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Bill and the establishment of the South African National Accreditation System (SANAS) as a public entity;- The transitional arrangements relating to the transfer of the assets and liabilities of the section 21 company and the migration of staff to the new body;- The appointment of a Board for a period of 12 months, from the date of Cabinet approval.

Parties consulted

National Treasury and Department of Public Service and Administration have been formally consulted in line with the PFMA on the reconstituting of SANAS as a public entity.Other stakeholders consulted:Departments of Labour, Transport, Agriculture, Housing, Health, Environmental Affairs and Tourism, Minerals and Energy, Science and Technology, Local and Provincial Government and the Presidency, SABS; CSIR NML; Industry and other interested parties; and Nedlac.

• Further consultations will be done by a Joint Committee with the dti, DPSA, National Treasury and SANAS as members.

   

Portfolio Committee Trade and Industry and National Assembly

• On 18 October the Committee passed a motion on the desirability to take the bill as a basis

• Classified it a Section 75 Bill• Passed the Bill with amendments• On 24 October the Second reading of the bill was

presented by the DM of Trade and Industry• All the parties supported the Bill and recommended

the briefing to the NCOPs Select Committee on Economic and Foreign Affairs

Financial implications

• The dti makes annual budget allocations for SANAS in terms of the MTEF;

• The current baseline of R6.787 million will need to be increased to R12.5 million as from the 2007/2008 budget cycle in order to provide for additional financial implications associated with the establishment and restructuring of SANAS as a public entity.

Personnel and organisational implications

• The Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Bill provides for transitional arrangements, including the transfer of all staff and the CEO from the current section 21 company to the public entity, as well as the transfer of assets and liabilities. The Bill also provides for the appointment of a Board by the Minister.

• It is proposed that the current SANAS Board assist in overseeing and supporting the transitional arrangements through to its conclusion. The Board’s term of office will run for 12 months, from the date of Cabinet approval.

• Cabinet Committee on Governance and Administration on 1 August 2006 recommended the approval of the abovementioned recommendations by Cabinet.

Summary• Experience over the past ten years has indicated the

need to acknowledge and strengthen government’s recognition of South African National Accreditation System (SANAS) as the national accreditation authority for calibration, conformity assessment and good laboratory practices.

• The Accreditation for Calibration, Conformity Assessment and Good Laboratory Practice Bill (the Bill) aims to establish a national accreditation body that is internationally recognised This entity will assist government interventions through legislation and technical regulations for example by determining the competencies of laboratories, certification bodies and rating agencies in order to support public policy objectives in terms of health, safety and broad-based black economic empowerment compliance issues.

Recommendations for Cabinet approval

• The introduction of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Bill and the establishment of the South African National Accreditation System (SANAS) as a public entity;

• The transitional arrangements relating to the transfer of the assets and liabilities of the section 21 company and the migration of staff to the new body;

• The appointment of a Board for a period of 12 months, from the date of Cabinet approval.