1Johannesburg South Africa SMA May 2007 www.iso.org International Organization for Standardization.

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1Johannesburg South Africa SMA May International Organization for Standardization

2Johannesburg South Africa SMA May 2007 Conformity Assessment Presentation to the ISOREGIONAL WORKSHOP by Mr. Sean Mac Curtain Head of Conformity Assessment, ISO Central Secretariat 9-10 May, 2007 – Johannesburg, South Africa

3Johannesburg South Africa SMA May 2007 ISO and conformity assessment Conformity Assessment: Demonstration that specified requirements relative to a product, process, system, person or body are fulfilled. World Trade Organization and international acceptance of tests and certificates International recognition and acceptance to be based on confidence and good practices The way forward: implementing the ISO/IEC Standards and Guides, with a double level of consensus, amongst countries and accross stakeholders

4Johannesburg South Africa SMA May 2007 ISO Strategic Plan Objective 6 : ISO, in cooperation with IEC, provides a comprehensive range of standards and guides for the implementation and recognition of good conformity assessment practices, suitable for all forms of first, second or third party involvement and evaluation, widely used by suppliers, conformity assessment operators and accreditors and recognized by customers and public authorities.

5Johannesburg South Africa SMA May 2007

6Johannesburg South Africa SMA May 2007 ISO/CASCO ISO Committee on Conformity Assessment CASCO undertakes both policy and technical work A support to international recognition of test results and certificates A neutral approach to the various routes to assess conformity 104 ISO members are represented in CASCO, of which 72 are participating members and 32 observers Nine international organizations are liaison members of CASCO: BIPM, IAF, IFAN, IFIA, IPC, IQNet, ILAC, OIML and UILI

7Johannesburg South Africa SMA May 2007 ISO/CASCO toolbox The CASCO toolbox consists of 26 documents covering: Vocabulary, principles and common elements of conformity assessment Code of good practice Product, system, and persons certification Testing, calibration, inspection, marks of conformity Supplier’s declaration of conformity, accreditation, peer assessment, and mutual recognition arrangements

8Johannesburg South Africa SMA May 2007 ISO/CASCO – Fundamental documents The ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles contains the terms, definitions and theoretical basis for conformity assessment – the functional approach. This approach identifies three distinct functions: selection, determination, review and attestation. The ISO/IEC Guide 60:2004 Conformity assessment – Code of Good Practice may be used in conjunction with the WTO- TBT Agreement, to facilitate trade CASCO is developing common elements for conformity assessment that shall be used in all CASCO documents. These common elements include: Impartiality, Confidentiality, Complaints & Appeals, Disclosure of information, and use of Management Systems in conformity assessment.

9Johannesburg South Africa SMA May 2007 SubjectDocumentPublication date Vocabulary Code of good practiceGuide Mutual Recognition Arrangements (MRA’s) Guide Peer assessment Accreditation Marks of conformity General standards and guides Components of the CASCO toolbox (1)

10Johannesburg South Africa SMA May 2007 Technical functions SubjectDocumentPublication date Suppliers declaration of conformity Testing & calibration laboratories17025 Guide Inspection Product certificationGuide 28, 67 Guides 65, 67, – System certification Person certification Components of the CASCO toolbox (2)

11Johannesburg South Africa SMA May 2007 CASCO projects recently completed ISO/IEC Part 1(CASCO WG 21), Conformity assessment — Requirements for bodies providing audit and certification of management systems ISO PAS (CASCO WG 23), Conformity assessment — Use of management systems in conformity assessment — Principles and requirements ISO/TS (TC 34/CASCO), Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems according to ISO 22000:2005 ISO (TC 207/CASCO ), Greenhouse gases — Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition

12Johannesburg South Africa SMA May 2007 CASCO projects in progress ISO/IEC (CASCO WG 27), Conformity assessment — Guidelines for drafting standards and specified requirements for conformity assessment applications. ISO/IEC (CASCO WG 28), Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes Part 2: Selection and use of testing schemes by laboratory accreditation bodies ISO/IEC Part 2 (CASCO WG 21), Conformity assessment — Requirements for third party auditing of management systems ISO/IEC Guide 65:1996 (CASCO WG 29) General requirements for bodies operating product certification systems (will become ISO/IEC 17065) CASCO to TMB reference document “Using and referencing ISO and IEC standards for technical regulation”

13Johannesburg South Africa SMA May 2007 Need to revise ISO/IEC Guide 65 The revision is need to align this specific document with the new revised CA documents (ISO/IEC 17021, 17024, 17020, and etc. as well the new IAF guidance) Align it with the common elements (PAS) documents on impartiality, appeals and complaints, confidentiality etc. Better define what is meant by processes and services in product certification and specify these in more detail in the document Is ambiguity a plus or a minus in the document? It allows for the many different schemes to be developed and is applicable to many process eg. Guide 65 must be applicable to a nuclear waste handling plant to a system that’s uses simple tests to demonstrate that a pipe can handle water for a fore extinguishing system

14Johannesburg South Africa SMA May 2007 Mandate of this revision CASCO resolution 7/2006: Draft a proposal for the scope and structure of the future standard taking into account the functional approach (selection, determination, review and attestation). This proposal to be circulated to CASCO members for comment and approval. Convenor is Mario Wittner (IRAM Argentina).

15Johannesburg South Africa SMA May 2007 SectorCertification Bodies Standard Bodies Regulators (National) Accreditation Bodies Scientific Institutes (NMI’s) Industry No Table 2: Breakdown of members by number Breakdown of CASCO WG 29 - Representation Total: 35 members + 6 Liaisons organisations Total : One unknown member SectorCertification bodies Standard Bodies Regulators (National) Accreditation Bodies Scientific Institutes (NMI’s) Industry % Table 1: Breakdown of members by percentage

16Johannesburg South Africa SMA May 2007Scope Scope: This international standard contains principles and requirements for the competence, consistency and impartiality of the certification of products (including services) and processes for the bodies providing those activities. The product certification systems used by the certification body may be the systems indicated in ISO/IEC Guide 67. First meeting of WG 29 was held in Geneva on 27 April 2006.

17Johannesburg South Africa SMA May 2007 WE WANT YOU! How can you participate in the revision of ISO/IEC Guide 65 ? By participating in your local committee which is through the ISO Member. You are encouraged to participate locally. SA has 4 members to the CASCO WG. No other African country represented on the WG.

18Johannesburg South Africa SMA May Thank you for your attention !