International Organization for Standardization

Update on the ISO 'tool box' of International Standards and Guides for conformity assessment Mario O. Wittner ISO/CASCO Chairman Update on the ISO 'tool box' of International Standards and Guides for conformity assessment Mario O. Wittner ISO/CASCO Chairman ISO CASCO/DEVCO - BIS Regional Workshop on Certification and Conformity Assessment Building Confidence for Developing Countries New Delhi–India, 6-7 December 2004

ISO STRATEGY in relation to conformity assessment SOME ACTIONS To encourage the reference and use of standards developed by CASCO by regulators and sector initiatives To consolidate the relationships with international accreditation bodies and the “operators” of conformity assessment To monitor the references to ISO name in relation to conformity assessment and the adherence to ISO ethical principles To provide, maintain and promote a set of standards extensively used for the implementation, evaluation and recognition of good practices of good practices in Conformity Assessment in Conformity Assessment

ISO/CASCO ISO develops International Standards and Guides on conformity assessment through its Committee on conformity assessment (ISO/CASCO) 99 countries are represented in ISO/CASCO To study means of assessing the conformity to standards To study means of assessing the conformity to standards To prepare international normative documents To prepare international normative documents To promote mutual recognition and appropriate use of International Standards To promote mutual recognition and appropriate use of International Standards

Process approach and structure Market Feedback Panel (MFP) Promoti on and Support Group (CAPS) CASCO WG5 WG12 WG14 WG18 WG19 WG21 WG22 WG23 WG24 WG25 WG26 Chairman's Policy and Coordinati on Group (CPC) Regulat ors Interfac e Group Technical work Use and feedback Study and policy Promotion and support

Study and policy Chairman’s Policy and Coordination Group (CASCO CPC) MAIN TASKS To receive mandates or requests from ISO Council, and CASCO members and other interested parties To create recommendations on policies To ensure fulfillment of the policies and directives approved (the “Standardization Framework”) To plan and assign priorities for the development of standards (the “Standardization Framework”)

ISO/CASCO CPC constitution MEMBERS: IEC/CAB President 6 CASCO “P” members: ABNT, AENOR, DGN, DSM, SAC, TSE MEMBERS: IEC/CAB President 6 CASCO “P” members: ABNT, AENOR, DGN, DSM, SAC, TSE CASCO Chairman

The CASCO four main policies (internal) Terminology Common elements Reference to QMS Sector specific documents

ISO/IEC Standards & Guides on Conformity Assessment (examples) SubjectPrevious ISO/IEC document in 2003 Present situationCompletion date VocabularyGuide 2: :2004 (WG 5) Code of good practiceGuide 60:1994Guide 60:2004 (WG 22) Suppliers declaration of conformityGuide 22: :2004 (WG 24) Product certificationGuide 65:1996 Guide 28:1982 Guide 28:2004 (WG 14) Guide 67:2004 (WG 14) System certificationGuide 62:1996 Guide 66: (WG 21) Person certification17024:2003 Marks of conformity 17030:2003 Testing and calibration laboratories17025:1999Amendment to (WG 25) Inspection17020:1998 AccreditationGuide 58:1993 Guide 61:1996 TR 17010: :2004 (WG 18) Peer assessment (WG 19)

The basic principles of international conformity assessment ISO/IEC 17000: VOCABULARY ISO/IEC Guide 2 Revision of clauses 12 to 17 The Functional Approach Selection, determination, Review and attestation, surveillance To put order Facilitation of trade: Terms in a special chapter

ISO/IEC Guide 60 Code of Good Practice for Conformity Assessment The Guide may be used in conjunction with the WTO-TBT Agreement, to facilitate trade Ethical and reliable CA services General principles on good practices for: CA normative documents CA activities CA systems and schemes CA results

Common elements in conformity assessment ISO/Council Resolution in 2001 requests CASCO to unify the common contents of its documents CASCO WG 23 is developing some basic common elements for conformity assessment, including: Impartiality and avoidance of conflicts of interest Confidentiality and trust (ISO PAS 17002:2004) Complaints and appeals (ISO PAS 17003:2004) Disclosure of information and transparency Use of management systems The common elements shall be used in all CASCO documents once the principles and texts are confirmed

1st party conformity assessment ISO/IEC 17050:2004 Parts 1 and 2 Supplier’s Declaration of Conformity (SDoC) 1st party attestation of conformity for: Products (including services); and Management systems SDoC can be used alone or with another conformity assessment procedure If a mark is applied to a product, then confusion with a certification (3 rd party attestation) mark has to be avoided SDoC can make reference to standards Annex A contains a form for presenting a SDoC

Requirements for testing and calibration laboratories ISO/IEC FDAM Alignment with ISO 9001:2000 Clause 4: Requirements for “Quality, administrative and technical, Management Systems” Conformity with ISO 9001 does not demonstrate, by itself, competence Conformity with ISO does not imply conformity with all the requirements of ISO 9001

3rd party conformity assessment Product certification ISO/IEC Guide 65:1996 establishes the requirements for product certification bodies ISO/IEC Guide 67:2004 outlines 7 product certification systems (from type testing to full certification) ISO/IEC Guide 28:2004 describes the most commonly used mix of product certification aspects – the so called ‘System 5 approach’ ISO/IEC Guide 53 builds on a system 5 approach to product certification by including the use of the organizations QMS in determining the product certification decision

3rd party conformity assessment Management system certification - ISO/IEC DIS Replaces Guides … applicable to bodies undertaking certification of any form of management system (e.g. food safety, OH&S, IT security etc) CASCO WG 21 Co-Conveners: an accreditation body a certification body Contentious issues: consultancy related bodies auditor competence Includes principles for building confidence impartiality technical competence responsibility transparency open system (“openness”) confidentiality appeals and complaints

3 rd party conformity assessment Management system certification - ISO/IEC DIS THE IMPACT WILL BE SIGNIFICANT + than 600,000 organizations certified ISO than 60,000 organizations certified ISO system certification bodies (IAF) Other management systems: for example, Food products safety, Health and Occupational Safety, Automotive, Aero-spatial, Telecommunications, etc.

Confidence in conformity assessment Accreditation - ISO/IEC 17011:2004 Main Objective: “one standard for the facilitation of the recognition process of the accredited conformity assessment activity” It replaces Guides 58 (Laboratory accreditation) and 61 (Certification body accreditation) and TR (Inspection body accreditation) It is also useful for the peer assessment of accreditation bodies Clear statement of incompatibility for the accreditation body between undertaking both accreditation and accredited activities It affects all 67 members of ILAC (some of whom are members of APLAC), and the 43 members of the IAF (some of whom are members of PAC) and … thousands of laboratories and certification bodies

Peer assessment of CA and accreditation bodies ISO/IEC (approved) An agreement group of CA bodies can have as goals:  Conformity of bodies with specified requirements  Equivalence of results among bodies  Acceptance of results from one body by other bodies Requirements for:  The management committee of the agreement group  Qualifications and selection of the peer assessors  Peer assessment process Annexes  Financial aspects  Assessment techniques

Outreach to regulators CASCO’s documents are designed to apply in both regulatory and voluntary conformity assessment settings CASCO has a special group – the Regulators Interface Group, convened by JISC (Japan) A survey of the use of CASCO documents in regulatory contexts is currently underway CASCO will broaden and expand its efforts to promote the International Standards and Guides on conformity assessment to various regulated sectors

The IAF-ILAC-ISO MoU In March 2004 the IAF-ILAC-ISO Memorandum of Understanding (MoU) was signed by the ISO Secretary General with approval of the ISO Council. The MoU: reaffirms ISO/IEC Standards and Guides as the source of requirements for accreditation and conformity assessment bodies and activities; recognizes that IAF and ILAC may establish guidance documents to ensure consistent application by accreditors, without adding requirements; establishes the IAF-ILAC-ISO JWG; confirms the CASCO Chair and Secretary as ISO’s main contact point with IAF and ILAC; confirms reciprocal involvement in each others work.

The IAF-ILAC-ISO MoU The last meetings of the JWG: Bern, June 2004 Amsterdam, November 2004

CASCO Five Years Plan Ongoing work DIS Management systems certification FD PAS Impartiality FD PAS Disclosure of information FD PAS Reference to QMS in CASCO documents WD 14065Greenhouse gas validation and verification bodies

The “Road Map” for CASCO 2007/2008 Common Elements and Terminology 2009 Product certification (under discussion) 2010 Accreditation and peer assessment …… Supplier’s declaration of conformity …… Management system certification.….. Certification of persons …… Laboratories

CASCO Five Years Plan New issues ? Guidance on writing technical regulations and standards that can be used in conformity assessment (revision of ISO/IEC Guide 7) Market surveillance (support from COPOLCO, Resolution ) Resolution ) Credibility of ISO 9001 certification Labelling Industry sector documents Requirements for auditors

CASCO assistance to developing countries CASCO/DEVCO “WORKSHOPS” GENEVA SEPTEMBER 2003 Latin America COPANT Salvador de Bahia, Brazil May 2004 South Asia New Dehli December 2004 CASCO: A MEMBER OF “JCDCMAS” – JOINT COMMITTEE ON COORDINATION AND ASSISSTANCE TO DEVELOPING COUNTRIES IN METROLOGY, ACCREDITATION AND STANDARDIZATION Southern Africa 2005 ASEAN region 2005

Further information Thank you for your attention Further information on conformity assessment can be found at the following link: markets/conformity/iso+conformity.html or Mr. Mario O. Wittner, CASCO Chairman or Mr. Graeme Drake, CASCO Secretary