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Page 1 ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services Presentation on the new standard.

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Presentation on theme: "Page 1 ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services Presentation on the new standard."— Presentation transcript:

1 Page 1 ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services Presentation on the new standard 2012-09-26

2 Page 2 Introduction This presentation has been developed by the Drafting Group of ISO CASCO WG 29. The aim is to support all interested parties concerned by the implementation of this new standard, e.g. conformity assessment bodies, accreditation bodies, industries with general information and contribute to an harmonized transition. This is an open presentation without any copyrights and can be used by anyone. We welcome any information about product certification in your region, country, e. g. number of schemes, number of accredited certification bodies, number of certificates under ISO/IEC Guide 65 / ISO/IEC 17065, if you have any please send it to charlet@iso.org ISO CASCO SecretaryISO CASCO Convenor WG 29 Sean MacCurtainChristian Priller 2012-09-26

3 Page 3 Table of content Importance / Impact of product certification for global trade4 Product, Process and Service Certification5 Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 170657 Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 1706510 Content of ISO/IEC Guide 65 to ISO/IEC 1706511 Changes of revision ISO/IEC Guide 65 to ISO/IEC 1706513 ISO/IEC 17065:201222 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:201237 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:199646 Back-up slides: examples 55 2012-09-26

4 Page 4 Examples - Importance and Impact of product certification for global trade An unknown number of sectors, regulators, schemes and CB‘s run their operation under this requirements with an unknown number of certificates and products, this shows the great importance. 2012-09-26 Europe: New Legilation Framework (NLF) over 20 European Directives, Trade volume 1500 mrd €, about 2000 Notified Bodies 974 accredited certification bodies in Europe (source: European Co-operation Accreditation) International level IEC CB Scheme: 74 National Certification Bodies 382 CB Testing Laboratories 45 Satellite Laboratories 2800 Manufacturer's Testing Laboratories 70'000 CB Test Certificates issues in 2011 Asia Japan JIS-mark : 25 certification bodies JAS-mark: 142 certification bodies PSE-mark: 10 certification bodies PSC-mark : 9 certification bodies PAL : 13 certification bodies China: 35 accredited Certification Bodies 10 Certification Bodies response for China Compulsory Certification (CCC) 50,728 companies with 280,000 certificates for CCC New Zealand/Australia 36 certification bodies for product certification 70 product certification schemes delivered by 36 accredited bodies Brasil 70 accredited Certification Bodies USA 120 Accredited Certification Bodies Germany: GS-mark 91 bodies

5 Page 5 Product, Process and Service Certification (1) The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfills specified requirements. The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfillment of specified requirements by a third-party. 2012-09-26

6 Page 6 Product, Process and Service Certification (2) Parties that have an interest in certification include, but are not limited to: the clients of the certification bodies; the customers of the organizations whose products, processes or services are certified; governmental authorities ; non- governmental organizations; and consumers and other members of the public. 2012-09-26

7 Page 7 Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 2012-09-26 dateactivityoutputParticipantsResults ballot 2007-04 1st WG 29 meeting – definition of scope and structure of revision WD1 30 2007-09 1 st DG meeting WD2 2008-04 2 nd DG meeting WD3 2008-04 2 nd WG 29 meeting WD4 35 2008-10 3 rd DG meeting WD5 2009-03 4 th DG meeting WD6 2009-06 3 rd WG 29 meeting CD1 37 2009-07 CD out for ballot 78% approval 1040 comments submitted 2010-03 Change of Convenor Mario Wittner > Christian Priller 2010-04 4 th WG 29 meeting 43

8 Page 8 Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 dateactivityoutputParticipationResults ballot 2010-06 5 th DG WG 29 meetingCD2 2010-08 CD2 out for ballot for two months 91% approval 570 comments submitted 2011-01 6 th DG meeting 2011-02 5 th WG 29 meeting in conjunction with WG 32 DIS 35 2011-05 DIS out for ballot 88% approval 440 comments submitted 2012-01 7 th DG meeting (Geneva) 2012-02 6 th WG 29 meeting (Munich)FDIS 30 2012-04 FDIS out for vote 2012-07 FDIS approved 95% approval in ISO and 100% in IEC 2012-09 PublicationIS 2012-09-26

9 Page 9 Timeline of Revision ISO/IEC Guide 67 to ISO/IEC 17067 Status of ISO/IEC 17067 Date Activity WG 32OutputParticipationResults (comments/voting) 2010-02 1st WG 32 meeting – definition of scope and structure of revision WD0 12 2010-09 2nd WG meeting WD1 10 2011-02 3 rd WG meeting WD2 15 2011-10 4 th WG meeting CD 12 2011-11 CD out for ballot 88% approval 2012-04 5 th WG meeting DIS 15 2012-06DIS out for ballot 2013-02 6 th WG meeting FDIS Q2 2013FDIS out for ballot Q3 2013IS out 2012-09-26

10 Page 10 Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 2012-09-26 Maintain the proven parts of Guide 65 Improve where necessary Maintain the proven parts of Guide 65 Improve where necessary ISO IEC Guide 65 ISO IEC 17065

11 Page 11 Content of ISO/IEC Guide 65 to ISO/IEC 17065 (1) 1.Scope2.Normative references3.Terms and definitions4.General requirements5.Structural requirements6.Resource requirements7.Process requirements8.Management system requirements 2012-09-26  The content is aligned with the new structural requirements decided by ISO CASCO (8 chapters instead of 15 in ISO/IEC Guide 65)

12 Page 12 Content of ISO/IEC Guide 65 to ISO/IEC 17065 (2) 1. ISO/PAS 17001 on Impartiality included in clause 4.22. ISO/PAS 17002 on Confidentiality included in clause 4.53. ISO/PAS 17003 on Complaints and appeals included in clause 7.134. ISO/PAS 17004 on Disclosure of information included in clause 4.65. ISO/PAS 17005 on Use of management systems included in clause 8 2012-09-26  The obligatory requirements of the ISO/PAS are included in ISO/IEC17065 * The PAS requirements may also be addressed in other parts of the standards than the ones listed above

13 Page 13 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (1) The scope in ISO/IEC17065 specifies as in ISO/IEC Guide 65 three objects of conformity assessment: product, process and service. New are the definitions of these three terms based on the definitions in ISO 9000 but as service certification is increasingly used there is a stand alone definition of “service” The scope together with Annex B gives information on the application of the standard for processes and services The scope clarifies that certification of products, processes and services is a third-party activity. The scope is to be read in connection with the definition of “certification body” in clause 3.12: third-party conformity assessment body operating certification schemes 2012-09-26

14 Page 14 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (2) Certification schemes are mandatory part of product certification (ISO/IEC17065). The requirement to operate one or more certification schemes is contained in clause 7.1.1. The term “scheme” replaces the term “system” used in ISO/IEC Guide 65 ISO/IEC 17065 does not contain detailed requirements on certification schemes. Guidelines for understanding, developing, establishing, maintaining or comparing certification schemes for products, processes and services will be provided in the future ISO/IEC 17067 “Fundamentals of product certification and product certification schemes” 2012-09-26

15 Page 15 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (3) consultancyevaluationproduct, process, servicecertification requirement, product requirementcertification scheme, certification scheme ownerscope of certificationcertification bodyimpartiality 2012-09-26  The definition chapter is considerably improved by definitions on

16 Page 16 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (4) The requirements on impartiality in clause 4.2 have significantly been improved compared with the requirements in clause 4.2 o) of ISO/IEC Guide 65. The obligatory requirements of PAS 17001 are incorporated in clause 4.2. Clause 4.2 clarifies in detail what activities can be performed by the certification body and any part of the legal entity it belongs to and what activities can be performed by organizations with which the certification body has relationships Supplementing the impartiality requirements, a mechanism for safeguarding impartiality is specified in clause 5.2. This mechanism is based on the recommended requirements in PAS 17001. It clarifies and details the provisions in clause 4.2 e) of ISO/IEC Guide 65 to enable the participation of parties significantly concerned. According to ISO/IEC17065 a possible mechanism can be a committee established by one or more certification bodies, a committee implemented by a scheme owner, a governmental authority or an equivalent party 2012-09-26

17 Page 17 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (5) The clause 6.2 on resources for evaluation is separated in internal resources and external resources (outsourcing). According to the definition in clause 3.3 of ISO/IEC17065, evaluation is a combination of selection and determination functions of a conformity assessment activity. Determination functions are normally testing, inspection and auditing. Internal and external resources shall meet the applicable requirements of the relevant International Standards and other documents as specified by the certification scheme. The relevant International Standards include for testing ISO/IEC 17025, for inspection ISO/IEC 17020 and for management system auditing ISO/IEC 17021 2012-09-26

18 Page 18 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (6)  The process chapter 7 follows the functional approach provided in ISO/IEC 17000 which consists of –selection –determination –review –attestation –surveillance  The functions “selection” and “determination” are in 17065 combined as function “evaluation” 2012-09-26 evaluation Decision and insuance of certificate if relevant

19 Page 19 Changes of revision ISO Guide 65 to ISO/IEC 17065 (7) The four-eyes principle contained in clause 4.2 f of ISO Guide 65 is kept in ISO/IEC17065 by clarifying that the review and decision has to be performed by person(s) different from those who carried out the evaluation whereas review and decision can be done by the same person(s) As in ISO/IEC Guide 65 the certification decision shall be made by person(s) employed by or under contract with the certification body meaning that subcontracting or otherwise delegating the certification decision is not allowed. The possibility to use person(s) for the decision who are under the organizational control (clause 7.6.4) of the certification body is new. Organizational control is for example whole or majority ownership regarding the legal entity that employs or contracts the person(s) who make the certification decision 2012-09-26

20 Page 20 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (8) The management system requirements are concentrated in chapter 8. According to PAS 17005 the certification body has two options to establish and maintain a management system that is capable of achieving the consistent fulfillment of the requirements of ISO/IEC 17065. The requirements of option A are provided in detail in chapter 8. Option B gives the possibility to use ISO 9001 as an alternative to fulfill the requirements contained in chapter 8 An informative Annex A contains principles for certification bodies and their certification activities which are not requirements. The listed principles are those inspiring confidence in the certification activities. Key words are impartiality, competence, confidentiality and openness, responsiveness to complaints and appeals and responsibility 2012-09-26

21 Page 21 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (9) Chapter 3Chapter 4Chapter 5Chapter 6 (detailed)Chapter 7 (detailed)Chapter 8 2012-09-26  Detailed presentation of the most important clauses of the new ISO/IEC17065:2012

22 Page 22 ISO/IEC 17065:2012 2012-09-26 Clause 3. Terms and definitions ISO/IEC 17065 and relation to ISO/IEC Guide 65 The definition chapter is considerably improved by definitions based on ISO/IEC 17000 Client Consultancy Evaluation product, process, service certification requirement, product requirement certification scheme, certification scheme owner scope of certification certification body Impartiality

23 Page 23 ISO/IEC 17065:2012 2012-09-26 Clause 4.1 Legal and contractual matters ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but more detailed description in: legal responsibility (4.1.1) certification agreement and use of licenses certificates (4.1.2) marks of conformity (4.1.3) 4. General requirements

24 Page 24 ISO/IEC 17065:2012 2012-09-26 Clause 4.2 Impartiality ISO/IEC 17065 and relation to ISO/IEC Guide 65 Significant improvements related to ISO/IEC Guide 65 : Identification of the risks to impartiality Impartiality in relation to other parts of the same legal entity and entities under organizational control Impartiality in relation to separate legal entities Firewalls to organizations or personnel providing consultancy 4. General requirements

25 Page 25 ISO/IEC 17065:2012 2012-09-26 Clause 4.3 Liability and financing ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but partially more detailed description Clause 4.4 Non-discrimi- natory conditions Clause 4.5 Confidentiality Clause 4.6 Publicly available informations 4. General requirements

26 Page 26 ISO/IEC 17065:2012 2012-09-26 Clause 5.1 Organization ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but partially more detailed description Clause 5.2 Safeguarding Impartiality 5. Structural requirements Significant changes related to ISO/IEC Guide 65 by introducing a mechanism for safeguarding impartiality which can be a committee established by one or more CB’s a committee implemented by a scheme owner a governmental authority or an equivalent party.

27 Page 27 ISO/IEC 17065:2012 2012-09-26 6.1 Personnel ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but partially more detailed description. 6.2 Evaluation resources 6. Resource requirements Significant changes related to ISO/IEC Guide 65 by introducing a more detailed description of internal and external resources. In ISO/IEC Guide 65, external resources is called subcontracting. Internal resources can also be resources under the direct control of the CB.

28 Page 28 ISO/IEC 17065:2012 2012-09-26 Clause 7.1 Scheme ISO/IEC 17065 and relation to ISO/IEC Guide 65 Replacement of the term “system” by the term “scheme”. Guidance on the development of schemes will be given in future by ISO/IEC 17067. Clause 7.2/7.3 Application 7. Process Requirements Application clause in ISO/IEC Guide 65 (8.2) is replaced in ISO/IEC 17065 by clauses 7.2 “application” and 7.3 “application review” which provides a more detailed information.

29 Page 29 ISO/IEC 17065:2012 2012-09-26 Clause 7.4 Evaluation ISO/IEC 17065 and relation to ISO/IEC Guide 65 The functions “selection” and “determination” are combined to the function “evaluation”. Apart from that no essential changes related to ISO/IEC Guide 65 but partially more detailed description 7. Process Requirements

30 Page 30 ISO/IEC 17065:2012 2012-09-26 ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7.5 Review 7. Process Requirements Introducing the function „review“ based on the functional approach provided in ISO/IEC 17000. A certification body must have all information and results related to the evaluation to complete the review

31 Page 31 ISO/IEC 17065:2012 2012-09-26 Clause 7.6 Decision ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65. New is the possibility to use persons for the decision who are under the organizational control of the CB. The function “decision” is based on the four-eyes- principal and can not be outsourced (subcontracted). 7. Process Requirements

32 Page 32 ISO/IEC 17065:2012 2012-09-26 Clause 7.7 Documentation ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO Guide 65 but partially more detailed description Clause 7.8 Directory 7. Process Requirements

33 Page 33 ISO/IEC 17065:2012 2012-09-26 Clause 7.9 Surveillance ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO Guide 65 but partially more detailed description. Clause 7.10 Changes 7. Process Requirements Clause 7.11 Status Improvement related to ISO Guide 65 by more detailed description of termination, reduction, suspension or withdrawal of certification. Improvement related to ISO Guide 65 by introducing a more detailed description of changes affecting certification (introduced by the scheme or initiated by the client).

34 Page 34 ISO/IEC 17065:2012 2012-09-26 7.12 Records ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 7.13 Complaints / Appeals 7. Process Requirements Alignment with ISO PAS 17003

35 Page 35 ISO/IEC 17065:2012 2012-09-26 Clause 8. Management- system ISO/IEC 17065 and relation to ISO/IEC Guide 65 Alignment with ISO PAS 17005, introducing two alternative options. The requirements for option A are contained in 8.2 to 8.8. Option B is based on ISO 9001.

36 Page 36 ISO/IEC 17065:2012 2012-09-26 Principles (Annex A) ISO/IEC 17065 and relation to ISO/IEC Guide 65 The informative Annex A contains the principles (no requirements) for product certification bodies and their activities. Process and services (Annex B) The informative Annex B provides explanations for application of this standard for certification of processes and services.

37 Page 37 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (1) To properly compare ISO/IEC Guide 65 and ISO/IEC 17065 and before going through the cross reference tables that follows, we recommend reading the document «contextual changes in Product certification since publication of ISO/IEC Guide 65» that is next to this presentation on ISO Online. As noted in this document, the underlying concepts of conformity assessment, and product certification in particular, advanced significantly between 1996 (the publication of ISO/IEC Guide 65) and 2009 (the initial drafting of ISO/IEC DIS 17065). In some cases the requirement from ISO/IEC Guide 65 has been CHANGED (not simply restated or reworded) and the cross reference is intended to highlight the change 2012-09-26

38 Page 38 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (2) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 1.1/1 st paragraph/competent1 1.1/1 st paragraph/third-party1 3 rd sentence/3.12 1.1/1 st paragraph/certification system 3.9/7.1.1System → scheme 1.1/2 nd paragraph/product, process, service 1 1 st sen./3.4/3.5/3.6/Annex B 1.27.1.1 Note 1 and 2 3.1 Supplier → client 4.1.14.4.1 4.1.24.4.2/4.4.3 4.1.3/1 st and 2 nd sentence7.1.2 4.1.3/3 rd sentence7.1.3 4.1.44.4.4 4.2 a)4.2 2012-09-26

39 Page 39 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (3) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 4.2 b)7.6.1 4.2 c)5.1.3 4.2 d)4.1.1 4.2 e) 1 st sentence5.1.1 4.2 e) 2 nd sentence4.2.4/5.2 4.2 f)7.6.2 4.2 g)4.1.2.1 4.2 h)4.3.1 4.2 i)4.3.2 4.2 j)6.1.1.1 4.2 k)8 4.2 l) 8.2.4, 5.1.2 2012-09-26

40 Page 40 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (4) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 4.2 m)4.2.2, 4.2.5 4.2 n)5.1.4 4.2 o)/related bodies4.2.7/4.2.8 4.2 o) 1)4.2.6 a) – c) 4.2 o) 2)4.2.6 d) and e) 4.2 o) 3)4.2.3 4.2 p)7.13 4.3/1 st paragraph/1 st sentence7.4.4 4.3/1 st paragraph/2 nd sentence7.1.2 4.3/2 nd paragraph6.2.1 4.46.2.2 4.4 Note 27.4.5 2012-09-26

41 Page 41 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (5) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 4.4 Note 37.4.5 Note 4.58 4.5.3 a)8.2.1 4.5.3 c)6.1.2.2 ISO/IEC17065 requirement applies only to individuals in the certification process 4.5.3 d)5.1.2 4.5.3 e)5.1.2 ISO/IEC17065 requirement more focused 4.5.3 f)8.5 4.5.3 g)8.3 4.5.3 h)8.2.5 4.5.3 i)6.1.2.1 4.5.3 j)6.2.2.4 d) 2012-09-26

42 Page 42 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (6) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 4.5.3 l)7 4.5.3 l) 1)7.11, 7.7.3 4.5.3 l) 2)8.3 4.5.3 m)7.13 4.5.3 n)8.6 4.6.117000 5.1; 17000 5.2; 7.6.2; 7.9.2; 7.11 4.6.2 a) and b)17000 5.1; 17000 5.2; 7.6.2; 7.9.2; 7.11 4.6.2 c)7.10 4.7.18.6 4.7.28.5 4.8.1 b)4.6 a) 4.8.1 c)4.6 a) 2012-09-26

43 Page 43 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (7) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 4.8.1 d)4.6 b) 4.8.1 e)4.6 c) 4.8.1 f)4.6 d) 4.8.1 g)7.8 4.8.28.2/8.3 4.97.12/8.4 4.104.5 4.10.16.1.1.3 5.1.16.1.1.2 5.1.26.1.2.1 d)/8.2.5 5.2.16.1.2.1 5.2.26.1.3 2012-09-26

44 Page 44 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (8) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 5.2.36.1.2.2 67.10 77.13 8.1.14.6 a), 4.6 c 8.1.24.1.2.2 8.1.34.6 a)/7.1.3 8.27.2, 7.3 8.2.1/application form7.2 Note 2 9.17.3.1 – 7.3.4 9.27.4.1 9.37.4.2 2012-09-26

45 Page 45 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (9) ISO/IEC Guide 65:1996ISO/IEC 17065:2012Remarks 9.47.4.3 107.4.4 117.4.9 11 b)/nonconformities7.4.6 12.17.6.2 12.27.6.1 12.37.7 12.47.10 137.9 13.24.1.2.2 k)/7.10 144.1.3 154.1.2.2 j) 2012-09-26

46 Page 46 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (1) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 11.1/1 st paragraph/competent 1 1 st sen./3.4/3.5/3.6/Annex B1.1/2 nd paragraph/product, process, service 1 3 rd sentence/3.121.1/1 st paragraph/third-party 3.1 3.41.1/2 nd paragraph/product, process, service 3.51.1/2 nd paragraph/product, process, service 3.61.1/2 nd paragraph/product, process, service 3.9/7.1.11.1/1 st paragraph/certification system 4.1.14.2 d) 4.1.2.14.2 g 4.1.2.28.1.2, 8.2.1

47 Page 47 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (2) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 4.1.3 14 4.24.2 a; 4.2 e; 4.2 m; 4.2 o 4.3.14.2 h 4.3.24.2 i) 4.4.14.1.1 4.4.2/4.4.34.1.2 4.4.34.1.2 4.4.44.1.4 4.54.10 4.6 a)4.8.1 b) 4.6 a)4.8.1 c) 4.6 a)8.1.1

48 Page 48 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (3) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 4.6 a)/7.1.38.1.3 4.6 b)4.8.1 d) 4.6 c)4.8.1 e) 4.6 d)4.8.1 f) 5.1.14.2 e) 1 st sentence 5.1.24.2 l) 5.1.24.5.3 d) 5.1.24.5.3 e) 17065 requirement more focused 5.1.34.2 c) 5.1.44.2 n)

49 Page 49 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (4) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 5.24.2 e) 2 nd sentence 6.1.1.1/6.1.1.24.2 j) 6.1.1.25.1.1 6.1.1.34.10.1 6.1.2.14.5.3 i) 6.1.2.15.2.1 6.1.2.1 d)/8.2.55.1.2 6.1.2.24.5.3 c) 17065 requirement applies only to individuals in the certification process 6.1.2.25.2.3 6.1.35.2.2 6.2.14.3/2 nd paragraph 6.2.24.4

50 Page 50 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (5) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 6.2.2.4 d)4.5.3 j) 7.1.11.1/1 st paragraph/certification system 7.1.1 Note 1 and 21.2 7.1.24.1.3/1 st and 2 nd sentence 7.1.24.3/1 st paragraph/2 nd sentence 7.1.34.1.3/3 rd sentence 7.1.38.1.3

51 Page 51 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (6) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 7.28.2 7.2 Note 28.2.1/application form 7.39.1 7.4.19.2 7.4.29.3 7.4.39.4 7.4.44.3/1 st paragraph/1 st sentence 7.4.410 7.4.54.4 Note 2 7.4.5 Note4.4 Note 3 7.4.611 b)/nonconformities

52 Page 52 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (7) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 7.4.911 7.6.14.2 b) 7.6.112.2 7.6.24.2 f) 7.6.212.1 7.712.3 7.84.8.1 g) 7.913 7.104.6.2 c) 7.106 12.4 7.1013.2

53 Page 53 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (8) 2012-09-26 ISO/IEC 17065:2012ISO/IEC Guide 65:1996 7.114.5.3 l) 1), 4.6.1; 4.6.2 a; 4.6.2 b 7.12/8.44.9 7.134.2 p) 7.134.5.3 m) 7.137 84.2 k) 8.2.44.2 l) 8.2.54.5.3 h) / 5.1.2 8.2/8.34.8.2 8.34.8.2 8.34.5.3 g)

54 Page 54 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (8) ISO/IEC 17065:2012ISO/IEC Guide 65:1996 8.34.5.3 l) 2) 8.44.9 8.54.5.3 f) 8.54.7.2 8.64.5.3 n) 8.64.7.1 8.74.5.3 k) Annex B1.1/2 nd paragraph/product, process, service 2012-09-26

55 Page 55 Back up slides The following slides are meant to complement the presentation as they give more details and provide some examples on some of the clauses and concepts of the standard These slides will be added to over time to make them more comprehensive. Any questions on the back up slides can be directed to CASCO Secretariat (charlet@iso.org) 2012-09-26

56 Page 56 History and Relationship 2012-09-26 1990 2000 2010 1980 ISO Guide 40 1983 ISO Guide 23 1982 ISO Guide 67 1981 ISO Guide 65 1996 ISO Guide 23 1982 ISO Guide 67 1981 ISO/IEC 17065 ISO/IEC 17067 2013 until than existing ISO Guide 23 and 67 2012

57 Page 57 Relation between certification body and scheme owner Scheme owner runs a scheme Guidelines for schemes are given in ISO/IEC 17067 Guidelines for schemes are given in ISO/IEC 17067 Requirements for certification bodies are given in ISO/IEC 17065 Scheme Stakeholder Scheme owner manufactorer, operator, deliverer of a product, process or services Certification Body and Conformity assessment Customer Scheme owner can be the certification body, governmenal authority, trade association, group of CB‘S, ….. ISO/IEC 17030 for the labels and their use 2012-09-26

58 Page 58 Examples of resources used for testing, inspection and auditing 2012-09-26 Testing with own ressource / equipment Use equipment from Manufacturer (under the CB control) Test reports from bodies or parties other than the CB Full outsourcing All those examples are covered in Clauses 6 of ISO/IEC 17065 Certification body

59 Page 59 Examples of Resources Personnel 2012-09-26 Certification Body Own Personnel Work Contract Free Lancer Contract related Company Agreement All those examples are covered in Clause 6 of ISO/IEC 17065

60 Page 60 Examples: how a CB can be positioned in a bigger organisation 2012-09-26 Holding Legal Entity 1 Div. 1.1 Business Area 1.1.1 Business Area. 1.1.2 Reg. 1.1Reg. 1.2 Legal Entity 2 CB Dep. 2.1 Legal Entity 3 Legal Entity 3.1 Legal Entity 3.2 Legal Entity 4 Div. 4.1 Div. 4.2 Div. 4.3 Ext. This shows possible position of a CB within a bigger organisation

61 Page 61 Example of possible arrangement for Organizational Control 2012-09-26 Certification Body Person/employee Related company Organizational Control is to supervise that the related company does not influence the person in its work for the CB Agreement to follow CB rules and procedure Work contract This relates to Clause 7.6.4 of ISO/IEC 17065. This is one possibility for organisational control among many

62 Page 62 Functional Approach 2012-09-26 … Selection … Determination … Review … Attestation … Surveillance Evaluation Insuance of a certificate after decision The right part of the chart (evaluation – Insuance of certificate) is the terminology used in ISO/IEC 17065 The functional approach is described in ISO/IEC 17000 (left part of the chart below)

63 Page 63 Process steps / requirements 2012-09-26 7.1 General7.2 Application7.3 Application review7.4Evaluation7.5Review7.6Certification decision7.7Certification documentation7.8Directory of certified products7.9Surveillance7.10Changes affecting certification7.11Termination, reduction, suspension or withdrawal of certification7.12Records7.13Complaints and appeals

64 Page 64 Maintenance group (1) Maintain a knowledge base (e.g. the reason why a requirement has been included).Assist CASCO Secretariat with queries related to the standard.Provide expertise and be available as a panel member for the interpretation process.Advise on any amendments and corrigendum between revisions.Any other function directly related to the content of the standard. 2012-09-26 The level of work is expected to be limited. There is no meeting foreseen. It is mainly required from the members to be available to fulfill the functions described above. Suggestion is that the members of the drafting group would be the members of the maintenance group. Mandate

65 Page 65 Maintenance group (2) Members 2012-09-26 Mr. Sumio AsadaJISC (Japan) Ms. Andrea Barroso Melo Monteiro de QueirozABNT (Brazil) Mr. Alister DalrympleAFNOR (France) Ms. Yunhua ChenSAC (China) Mr. Ian CleareBSI (United Kingdom) Mr. Graeme DrakeSA (Australia) Mr. Reinaldo FigueiredoANSI (USA) Mr. Steve KeelingSA (Australia) Mr. Pedro LosteAENOR (Spain) Mr. Leif MadsenDS (Denmark) Mr. Paul MoliskiIAF Mr. Keith MowryANSI (USA) Mr. Christian Priller (Convenor WG 29)DIN (Germany) Mr Jaap PrummelNEN (Netherlands) Mr. Lorenz RoggliSNV (Switzerland) – ILAC Mr. Hinrich SchaubON (Austria) Mr. Thomas FacklamIAF Mr. Hanspeter IschiSNV (Switzerland) – ILAC alternate Mr. Heribert Schorn(DIN – Germany) Mr. Alan SquirrellILAC Mr. Pierre de RuvoIEC

66 Page 66 Thank you … a great work goes to finish … After a long and intensive work with ISO CASCO WG 29 over the last years I like to say Thank you as your Convenor, hopefully not to forget somebody or something now, If so, I say sorry in advance. I like to say Thank you to ISO Secretary, to all of them, To my parent Convenor Mario Wittner, To all of you and to everybody for your great credit, support and nice and hard discussions, To the support of the Drafting Group, without them it would not be possible for me. Looking in front of, I see the result of a very well balanced new standard for the economic system and all participants in the system. And hope to see you all soon, it was a pleasure for me to work so close with you ! I wish you all good luck, health and success Yours Christian Priller, Convenor 2012-09-26


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