USAid presentation, Bishkek, Kyrgyzstan 2002-11-10 The international technical infrastructure and the International Organization for Standardization (ISO) Graeme Drake, ISO Central Secretariat, Geneva 12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan The international technical infrastructure - Graeme Drake, ISO

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

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

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

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

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

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

ISO standardization in the model Policy Metrology (measurement and physical standards) Documentary standards Certification and claims of conformity Accreditation Peer Assessment 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 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

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

Specific CASCO documents Current document New document Group Date 1st Party ISO/IEC Guide 22:1996 General criteria for supplier’s declaration of conformity ISO/IEC 17050 and 17049 WG 24 SDoC Aug 2004 2nd Party No specific documents 3rd Party ISO/IEC Guide 23:1982 Methods for indicating conformity with standards for third-party certification systems Systematic review 2003 ISO/IEC Guide 28:1982 General rules for a model third-party certification system for products ISO/IEC Guide 28 WG14 Apr 2005 ISO/IEC Guide 53:1998 An approach to the utilization of a supplier's quality system in third party product certification Guide 53 Adhoc Group on Guide 53 May 2004

Specific CASCO documents (2) 3rd Party ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems ISO/IEC Guide 62:1998 General requirements for bodies operating assessment and certification/registration of quality systems ISO/IEC 17021 General requirements for bodies operating assessment and certification of management systems WG 21 Management systems 2005 ISO/IEC Guide 66:1999 General requirements for bodies operating assessment and certification/registration of environmental management systems (EMS) ISO/IEC Guide 67 Fundamentals of product certification WG 14 Product certification April 2005 ISO/IEC 17024 General requirements for bodies operating certification of persons WG 17 Personnel certification July 2003

Supporting processes Regardless of what type of assessment of conformity is being employed there are some fundamental process steps Current document New document Group Date Testing Methods of test stipulated by TCs ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories ISO/IEC 17025:1999 AMD1 WG 25 Jun 2004 Inspection ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection Auditing ISO/IEC 19011:2002 Guidelines for quality and/or environmental management systems auditing

Accreditation and Peer Assessment Current document New document Group Date Accreditation ISO/IEC Guide 53:1993 Calibration and testing laboratory accreditation systems -- General requirements for operation and recognition ISO/IEC 17011 General requirements for bodies providing assessment and accreditation of conformity assessment bodies WG 18 Feb 2004 ISO/IEC Guide 21:1996 General requirements for assessment and accreditation of certification/registration bodies ISO/IEC TR 17010:1998 General requirements for bodies providing accreditation of inspection bodies Peer Assessment ISO/IEC Guide 43:1997 Parts 1 and 2, Proficiency testing by interlaboratory comparisons ISO/IEC 17040 General requirements for peer assessment of conformity assessment bodies WG 19 Dec 2004

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

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

USAid presentation, Bishkek, Kyrgyzstan 2002-11-10 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 The international technical infrastructure - Graeme Drake, ISO