1 / 27

iso

International Organization for Standardization. www.iso.org. ISO CASCO/DEVCO - BIS Regional Workshop on Certification and Conformity Assessment Building Confidence for Developing Countries New Delhi–India, 6-7 December 2004.

johnda
Download Presentation

iso

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. International Organization for Standardization www.iso.org

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

  3. ISO STRATEGY 2005-2010in 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 in Conformity Assessment

  4. 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 prepare international normative documents To promote mutual recognition and appropriate use of International Standards

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

  6. Study and policyChairman’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”)

  7. ISO/CASCO CPC constitution CASCO Chairman

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

  9. ISO/IEC Standards & Guides on Conformity Assessment (examples) Subject Previous ISO/IEC document in 2003 Present situation Completion date Vocabulary Guide 2:1996 17000:2004 (WG 5) 2004-11 Code of good practice Guide 60:1994 Guide 60:2004 (WG 22) 2004-10 Suppliers declaration of conformity Guide 22:1996 17050:2004 (WG 24) 2004-10 Product certification Guide 65:1996 Guide 28:1982 Guide 28:2004 (WG 14) Guide 67:2004 (WG 14) 2004-10 System certification Guide 62:1996 Guide 66:1999 17021 (WG 21) 2006-06 Person certification 17024:2003 Marks of conformity  17030:2003 Testing and calibration laboratories 17025:1999 Amendment to 17025 (WG 25) 2005-04 Inspection 17020:1998 Accreditation Guide 58:1993 Guide 61:1996 TR 17010:1998 17011:2004 (WG 18) 2004-09 Peer assessment 17040 (WG 19) 2005-03

  10. The basic principles of international conformity assessment ISO/IEC 17000:2004 - 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

  11. 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

  12. 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

  13. 1st party conformity assessmentISO/IEC 17050:2004 Parts 1 and 2Supplier’s Declaration of Conformity (SDoC) • 1st party attestation of conformity for: • Products (including services); and • Management systems If a mark is applied to a product, then confusion with a certification (3rd party attestation) mark has to be avoided SDoC can make reference to standards SDoC can be used alone or with another conformity assessment procedure Annex A contains a form for presenting a SDoC

  14. Requirements for testing and calibration laboratoriesISO/IEC FDAM 17025 Clause 4: Requirements for “Quality, administrative and technical, Management Systems” Alignment with ISO 9001:2000 Conformity with ISO 9001 does not demonstrate, by itself, competence Conformity with ISO 17 025 does not imply conformity with all the requirements of ISO 9001

  15. 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

  16. 3rd party conformity assessment Management system certification - ISO/IEC DIS 17021 Replaces Guides 62 + 66 + … 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

  17. 3rd party conformity assessment Management system certification - ISO/IEC DIS 17021 THE IMPACT WILL BE SIGNIFICANT + than 600,000 organizations certified ISO 9001 + than 60,000 organizations certified ISO 14 001 1321 system certification bodies (IAF) Other management systems: for example, Food products safety, Health and Occupational Safety, Automotive, Aero-spatial, Telecommunications, etc.

  18. Confidence in conformity assessmentAccreditation - ISO/IEC 17011:2004 • 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 • 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 17 010 (Inspection body accreditation) • It is also useful for the peer assessment of accreditation bodies

  19. Peer assessment of CA and accreditation bodiesISO/IEC 17040 (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

  20. 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

  21. 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.

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

  23. CASCO Five Years PlanOngoing work DIS 17 021 Management systems certification FD PAS2 17 001 Impartiality FD PAS 17 004 Disclosure of information FD PAS 17 005 Reference to QMS in CASCO documents WD 14065 Greenhouse gas validation and verification bodies

  24. 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 • …… 17 025 - Laboratories

  25. CASCO Five Years PlanNew 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 16-2004) • Credibility of ISO 9001 certification • Labelling • Industry sector documents • Requirements for auditors

  26. 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 Southern Africa 2005 ASEAN region 2005 CASCO: A MEMBER OF “JCDCMAS” – JOINT COMMITTEE ON COORDINATION AND ASSISSTANCE TO DEVELOPING COUNTRIES IN METROLOGY, ACCREDITATION ANDSTANDARDIZATION

  27. Further information Thank you for your attention Further information on conformity assessment can be found at the following link: http://www.iso.org/iso/en/comms-markets/conformity/iso+conformity.html or email: Mr. Mario O. Wittner, CASCO Chairman (mwittner@iram.org.ar) or Mr. Graeme Drake, CASCO Secretary (drake@iso.org)

More Related