12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan

1. The international technical infrastructure and the International Organization for Standardization (ISO) 12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan Graeme Drake, ISO Central Secretariat, Geneva

2. 5 topics… • Technical infrastructure model • The model at various levels – an example • Reasons why we need it • The role of ISO in the model • Standards and conformity assessment practices

3. Technical infrastructure model • Certification and claims of conformity • This is the process by which a person or company claims a good or service is in compliance with a standard or technical specification • 1st party • 2nd party • 3rd party • After certification or a claim of conformity, at any level, marks of conformity can be issued to the product or service • Testing and inspection activities Peer assessment and accreditation services Backup level of check. Often government or quasi-government bodies  These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes) Basis for MRAs Regional bodies • Policy • Government Ministry or Department • Technical infrastructures affect: • manage risk; • be economically efficient; • incorporate ‘externalities’ and protect against market failure; • ensure the public's confidence in the economy; and • participate in the free trade of goods and service WTO Agreements Regional groupings Metrology (measurement and physical standards) Legal metrology (weights and measures) Scientific measurement (microbiological, chemical and non legal physical properties) - Generally a mixture of government owned or private laboratories and research interests International organisations (BIPM and OIML) Regional bodies Documentary standards A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative In some sectors government Ministries or Departments make and define documentary standards International standardisation bodies (ISO, IEC, ITU,CODEX etc) Regional bodies

4. International Regional APLMF Australia New Zealand Trading Standards Service (Legal weights and measures) Measurement Standards Laboratory Regulators IEC ITU-T CODEX Agreement on Technical Barriers to Trade Many levels to the technical infrastructure IQNet, IIOC Certification bodies POLICY METROLOGY (PHYSICAL STANDARDS) SCIENTIFIC LEGAL DOCUMENTARY STANDARDS CERTIFICATION AND CLAIMS OF CONFORMITY PEER ASSESSMENT AND ACCREDITATION Certification bodies

5. The basics… why we need a technical infrastructure? • Internal reasons - Efficient and sustainable domestic economies • Economic development and poverty alleviation – technology transfer • Good regulatory practice (GRP) - OECD, APEC and the European ‘New Approach’ – from prescriptive to performance based laws • Level of government intervention and economic efficiency • Risk management • Address market failure – social, health and safety, environment • Allowing for innovation • Interoperability and interconnectivity – the knowledge economy

6. The basics… why we need a technical infrastructure? • External reasons - Trade – A nation’s competitive advantage • Economic efficiency through competition • International commitments – WTO - Notification • Globalisation and competitive advantage • Private sector requirements • Managerial, owner (shareholder) and consumer confidence • Contractual specifications • Marketing and brand differentiation

7. ISO and its structure • ISO is a international technical NGO • 140 countries, a mixture of government, semi-government and private bodies • Each national member body is to represent its government, industry and consumer views • Develops international policy and reflects this in international standards and guides • Recognition with related bodies include IEC, ITU and sector specific standardising bodies • Liaison with a number of international bodies • Its special because it produces both sector and horizontal standards and guides

8. Over 200 technical committees in various sectors, over 2000 subcommitees and working groups One of the international standardising bodies (IEC, ITU-T, CODEX etc) Technical committees and standards development managed by individual ISO member bodies in accordance with the ISO/IEC Directives through consensus Number of possible publications ISO 9001:2000 one of its biggest standards Increasing adoption and usage of international standards due to WTO agreements ISO standardization in the model Policy Metrology (measurement and physical standards) Documentary standards Certification and claims of conformity • Accreditation • Peer Assessment

9. ISO conformity assessment in the model Policy Metrology (measurement and physical standards) Documentary standards Certification and claims of conformity • Accreditation • Peer Assessment • Developing the technical requirements, including the publishing of a standard, is ½ the story • After that, mandatory or voluntary assessment of the product, system or service may be required, and sometimes a mark of conformity as well • This has the potential to either increase or decrease costs, or enhance or retard international trade • ISO/CASCO has developed international guides and standards on how to undertake this assessment function – i.e. assessment of conformity – conformity assessment Conformity assessment

10. Types of assessment of conformity • Declaration of conformity by 1st party • Suppliers declaration of conformity (SDoC) • CASCO future standards 17050 and 17049 • Assessment of conformity by 2nd party • Procurement chain contracts • Government purchasing • Assessment of conformity by 3rd party • Product certification • Management systems certification • Mandatory or voluntary conformity assessment

11. Specific CASCO documents

12. Specific CASCO documents (2)

13. Supporting processes • Regardless of what type of assessment of conformity is being employed there are some fundamental process steps

14. Accreditation and Peer Assessment

15. Marks of conformity assessment • CASCO WG 12 is developing ISO/IEC 17030 Third party marks of conformity and their use • Products cannot carry systems related compliance marks • Systematic review will take place of ISO/IEC Guide 27:1983 Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity in 2003 • Implications for the discussion of labelling at the WTO TBT

16. G2G MUTUAL RECOGNITION REGULATOR REGULATOR DESIGNATES DESIGNATES ACCREDITATION BODY A ACCREDITATION BODY B VOLUNTARY MUTUAL RECOGNITION ISO/IECGuides and Standards ISO/IEC Guide 68 MRAs – Dec 2002 ACCREDITS ACCREDITS CONFIDENCE CONFIDENCE CERTIFICATION BODIES CERTIFICATION BODIES CERTIFIES CERTIFIES Management System / Product/Personnel/ laboratories and tests Management System / Product/Personnel/ laboratories and tests Mutual recognition arrangements

17. Further information on conformity assessment can be found at the following link: http://www.iso.org/ or email Graeme Drake, Head of Conformity Assessment and Secretary of ISO/CASCO at drake@iso.org