ACCREDITATION FOR CONFORMITY ASSESSMENT, CALIBRATION AND GOOD LABORATORY PRACTICE BILL, August 2006

“Metrology, standardisation and conformity assessment (including accreditation) are used by business and government to optimise production, health, consumer protection, environment, security and quality. Their effective implementation supports sustainable development and social welfare, and facilitates trade”. ISO – emphasis added

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 Summary

Technical Infrastructure Accreditation, together with metrology, standards and conformity assessment are collectively referred to as the 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). Responsible institutions in this regard 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 ASSESSMENT Prove technical requirements are met Testing, Inspection & Certification SUPPLIERCUSTOMER VOLUNTARY SECTOR Customer/Market Requirements REGULATORS Administer regulations REGULATED SECTOR GOVERNMENT Set policy, laws & technical regulations NMI- MEASUREMENT Underpins testing & calibration through national measurement standards SANAS- ACCREDITATION Assures competence SABS- STANDARDS Specific technical requirement of a product or a system

Globalisation and Technical Infrastructure SOUTH AFRICA SADCMET EUROMET APMP SADCA EA APLAC SADCSTAN CEN/CENELEC PASC REGIONAL INTERNATIONAL Standardisation (ISO/IEC) Accreditation (ILAC/IAF) Metrology /BIPM) SABSSANASNMI WTO TBT

International practice in accreditation In 1996 accreditation bodies formed the International Laboratory Accreditation Cooperation (ILAC). The International Accreditation Forum (IAF) was formed in The relationship between national accreditation bodies are governed through mutual recognition arrangements (MRA). 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 are based on peer assessments by teams of experts. They assess the competence of national accreditation bodies and their compliance to international codes of best practice National accreditation bodies in turn use international agreed to standards such as ISO/IEC 17025, ISO/IEC and guides 61 and/or 62 for the accreditation of laboratories, inspection and certification bodies, respectively.

History of National Accreditation System Established in 1994 by a Cabinet decision. The approved corporate form was a Section 21 company. 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 creates lack of ownership A critical issue is the strength of Government’s recognition of SANAS as the national accreditation authority There is a chance that departments may set up separate accreditation systems because of lack of a legislative framework. New profile is necessary for SANAS to reflect its complementary role to the SABS and the NMI. The current corporate form is not conducive for government departments to make extensive use of SANAS.

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 Strengthen of Government’s recognition of SANAS as the national accreditation authority for conformity assessment, calibration and good laboratory practices; Maintain SANAS as an internationally recognised accreditation body; Encourage government use SANAS accreditation in an effective and unified manner. Enable 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 such as ASGISA and the Industrial Policy

The purpose of the Accreditation bill Establish SANAS as a Public entity. To provide an internationally recognised accreditation and GLP monitoring system for SA

Mandate Provides for an independent process and assessment whereby the competence to perform a specific service of conformity assessment can be determined. Thus provides for confidence in the competence and reliability of testing, inspection, certification service providers, and lately BBBEE rating agencies.

Objectives 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. Promote the competence of BBBEE rating agencies.

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 benchmarked against Brazil, Australia, UK and Malaysia. Cabinet approved project for restructuring of Technical Infrastructure on 22 May the dti Policy on Modernising the South African Technical Infrastructure approved June Workshops held with government departments and industry on policy position July This was supplemented by letters to DGs of various departments – August Written comments solicited from all stakeholders until September 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 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.

Financial implications The dti makes annual budget allocations for SANAS in terms of the MTEF; The current baseline of R6.8 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 conformity assessment, calibration 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.