International Organization www.iso.org International Organization for Standardization

International Standards and Conformity Assessment by Mr. Graeme Drake, Head of Conformity Assessment ISO Central Secretariat UNECE WP6 on Regulatory Cooperation and Standardization Policies Geneva, Switzerland 24 November, 2004

The technical infrastructure Corporate, Public and Trade Policy Industry association, Government Ministry or Department Require technical infrastructure to: 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 UN and WTO 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 Regional bodies Claims of conformity and certification   This is the process by which a person or company claims a good or service conforms with a standard or technical specification 1st party 2nd party 3rd party After a claim of conformity or certification, at any level, marks of conformity can be issued to the product or service Testing and inspection activities Accreditation and peer assessment services   Further activity to ensure confidence, consistency and competence 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

Standardization in the model Policy Metrology (measurement and physical standards) Documentary standards Claims of conformity and certification Accreditation Peer Assessment Over 200 technical committees in various sectors, over 2000 subcommittees 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 General adherence by national bodies to rules for standards

Conformity assessment Policy Metrology (measurement and physical standards) Documentary standards Claims of conformity and certification Accreditation Peer Assessment Developing technical requirements in regulations or standards is ½ the story After that, mandatory or voluntary testing, inspection and assessment of the product, system or service may be required, and sometimes this results in a lable or a mark of conformity This has the potential to affect production costs, economic efficiency, and international trade ISO and IEC jointly produce international guides and standards that set the agreed requirements on how the international conformity assessment operates. This is done through the ISO Committee on conformity assessment (CASCO) which has 99 countries represented Conformity assessment

ISO and its structure ISO is a international technical NGO 148 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 Based on consensus through application of the ISO/IEC Directives Recognition with related bodies include IEC, ITU and sector specific standardising bodies Liaison with a number of international bodies

ISO and the WTO/TBT Fully compliant with the six WTO/TBT criteria for international standards WTO TBT 3rd Triennial Review: Good Regulatory Practices “… minimizing the use of mandatory technical regulations and utilizing voluntary international standards, where appropriate, could reduce the regulatory burden and open up market access opportunities” “… avoidance of unnecesary obstacles to trade in the preparation, adoption and application of technical regulations (including associated standards) and conformity assessment procedures, including those related to labelling”

ISO and the WTO/TBT Article 5 “… Sets out (for government bodies) … the use of international guides or recommendations …” and “… the importance of Members using … and playing a full part … in the preparation by appropriate international standardizing bodies of guides and recommendations for conformity assessment procedures …” “... Moreover the Committee (TBT) notes the increasing development of international standards for conformity assessment procedures”.

ISO and the WTO/TBT “ … Article 6.1.1 Accreditataion “identifies accreditation as a possible tool for Members to verify the technical competence of CA bodies”. “When operated according to relevant international standards, … accreditation offers a mechanism which could promote confidence”. “This could reduce trade barriers when governmental … authorities accept the results of accredited bodies”. “Members ensuring that accreditation bodies follow … provisions on transparence and openess”.

ISO/CASCO 99 members of ISO are members of CASCO CASCO undertakes both policy and technical work At present it is undertaking a major revision of most of its documents, converting some of them (those specifying requirements) from guides to standards There are four areas of focus: Study and policy Technical work (the tool box) Promotion and advice Market feedback

Process and structure Study and policy Technical work Use and feedback Market Feedback Panel (MFP) Promotion and Support Group (CAPS) CASCO WG5 WG12 WG14 WG18 WG19 WG21 WG22 WG23 WG24 WG25 WG26 Chairman's Policy and Coordination Group (CPC) Regulators Interface Group Technical work Use and feedback Study and policy Promotion and support

Principle 1 – the functional approach Accepted by CASCO in 2002, the functional or process approach sets out the generic framework for all conformity assessment activities This forms the basis for the new international standard on conformity assessment vocabulary (17000)

Principle 2 – International agreements WTO Agreements ISO/IEC Guide 60:2004, Code of good practice

Principle 3 – Common elements Internally focused exercise to ensure international documents on conformity assessment approach the following elements in a common way for consistency: Impartiality Confidentiality and public disclosure Complaints and appeals Management systems

General CASCO documents ISO/IEC 17000:2004 Vocabulary and general principles and ISO/IEC Guide 2:2004 ISO/IEC Guide 60:2004 Code of good practice Common elements Impartiality (will be PAS 17001) ISO PAS 17002:2004 Confidentiality ISO PAS 17003:2004 Complaints and appeals Disclosure of information (will be PAS 17004) Use of management systems in conformity assessment (will be PAS 17005)

CASCO documents for claims of conformity - general Testing and calibration laboratories ISO/IEC FDAM 17025 – to become ISO/IEC 17025:2005 Proficiency testing ISO/IEC Guide 43:1997 Inspection bodies ISO/IEC 17020:1998

CASCO documents for claims of conformity 1st party – ISO/IEC 17050:2004 Supplier’s declaration of conformity 3rd party – Product certification ISO/IEC Guide 67:2004 Fundamentals of product certification ISO/IEC Guide 28:2004 ‘System 5’ ISO/IEC Guide 53:2005 Use of the suppliers QMS in product certification ISO/IEC Guide 65:1996 for product certification bodies 3rd party – Management systems certification (ISO/IEC Guides 62 and 66 to be replaced by ISO/IEC 17021) 3rd party – Marks of conformity (ISO/IEC 17030:2003)

ISO/IEC Guide 67:2004 Outlines 7 product certification systems that combine several of the following core elements related to product certification: Sampling Testing Evaluation Decision Licensing Surveillance

ISO/IEC Guide 28:2004 General description of one organizational and operating approach to product certification based on system 5 in ISO/IEC Guide 67 ISO/IEC Guide 28 covers: Contracting Sampling Testing Evaluation Surveillance Certification decision

ISO/IEC Guide 28:2004 Provides model documents Checklist for selecting product requirements Application for product certification Contract Factory inspection Conformity certificate

CASCO documents for confidence and mutual recognition ISO/IEC 17011:2004 Accreditation ISO/IEC 17040:2005 Peer assessment ISO/IEC Guide 68:2002 Mutual recognition of conformity assessment results (MRAs)

ISO/IEC 17011:2004 ISO/IEC 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies Will replace: ISO/IEC Guide 58:1993, Calibration and testing laboratory accreditation systems -- General requirements for operation and recognition ISO/IEC Guide 61:1996, General requirements for assessment and accreditation of certification/registration bodies ISO/IEC TR 17010:1998, General requirements for bodies providing accreditation of inspection bodies

ISO/IEC 17011 contd. Scope Normative references Terms and definitions Accreditation body Management Human resources Accreditation process Responsibilities of the accreditation body and the conformity assessment body

ISO/IEC 17011 contd. inclusion of ‘impartiality’ prohibition on directly undertaking other conformity assessment services or consultancy; bodies related to the accreditation body may do this but must have: different top management different people no influence distinctly different name, logos and symbols deliberate identification and management of relationships that have the potential for a conflict of interest;

Process and structure Study and policy Technical work Use and feedback Market Feedback Panel (MFP) Promotion and Support Group (CAPS) CASCO WG5 WG12 WG14 WG18 WG19 WG21 WG22 WG23 WG24 WG25 WG26 Chairman's Policy and Coordination Group (CPC) Regulators Interface Group Technical work Use and feedback Study and policy Promotion and support

Promotion and Support Help in writing International Standards so that they may be used in conformity assessment Promote CASCO ‘tool box’ to end users Provide advice on establishment of conformity assessment systems Have a specific focus on the use of CASCO documents by regulators ISO Brochure on Publicising your ISO 9001 and ISO 14001 certification

Market feedback Gives interpretations on CASCO documents Undertakes market research and surveys to find out how widely are the CACSO documents used and what people think of them Regulators survey 2004 Triennial comprehensive survey of use and national adoption of CACSO documents Advises CASCO on new documents and timing of revisions based on market feedback

Thank you for your attention Please ask questions! Mr. Graeme Drake, (drake@iso.org)