ISO IEC 17065 2012 Conformity assessment Requirements for

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

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 Secretary Sean Mac. Curtain Page 2 2012 -09 -26 ISO CASCO Convenor WG 29 Christian Priller

Table of content • Importance / Impact of product certification for global trade 4 • Product, Process and Service Certification 5 • Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 7 • Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 10 • Content of ISO/IEC Guide 65 to ISO/IEC 17065 11 • Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 13 • ISO/IEC 17065: 2012 22 • Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 37 • Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 46 • Back-up slides: examples 55 Page 3 2012 -09 -26

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. Asia 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 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) Germany: GS-mark 91 bodies 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 Page 4 2012 -09 -26 USA 120 Accredited Certification Bodies

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. Page 5 2012 -09 -26

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

Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 date activity 2007 -04 1 st WG 29 meeting – definition of scope and structure of revision WD 1 2007 -09 1 st DG meeting WD 2 2008 -04 2 nd DG meeting WD 3 2008 -04 2 nd WG 29 meeting WD 4 2008 -10 3 rd DG meeting WD 5 2009 -03 4 th DG meeting WD 6 2009 -06 3 rd WG 29 meeting CD 1 2009 -07 CD out for ballot 2010 -03 Change of Convenor Mario Wittner > Christian Priller 2010 -04 4 th WG 29 meeting Page 7 2012 -09 -26 output Participants Results ballot 30 35 37 78% approval 1040 comments submitted 43

Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 date 2010 -06 activity output 5 th DG WG 29 meeting Participation Results ballot CD 2 91% approval 570 comments submitted 2010 -08 CD 2 out for ballot for two months 2011 -01 6 th DG meeting 2011 -02 5 th WG 29 meeting in conjunction with WG 32 DIS 2011 -05 DIS out for ballot 2012 -01 7 th DG meeting (Geneva) 2012 -02 6 th WG 29 meeting (Munich) FDIS 2012 -04 FDIS out for vote 2012 -07 FDIS approved 2012 -09 Publication IS Page 8 2012 -09 -26 35 88% approval 440 comments submitted 30 95% approval in ISO and 100% in IEC

Timeline of Revision ISO/IEC Guide 67 to ISO/IEC 17067 Date Activity WG 32 Output Participation 2010 -02 1 st WG 32 meeting – definition of scope and structure of revision WD 0 12 2010 -09 2 nd WG meeting WD 1 10 2011 -02 3 rd WG meeting WD 2 15 2011 -10 4 th WG meeting CD 12 2011 -11 CD out for ballot 2012 -04 5 th WG meeting DIS 2012 -06 DIS out for ballot 2013 -02 6 th WG meeting FDIS Q 2 2013 FDIS out for ballot Q 3 2013 IS out Results (comments/voting) Status of ISO/IEC 17067 Page 9 2012 -09 -26 88% approval 15

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

Content of ISO/IEC Guide 65 to ISO/IEC 17065 (1) Ø The content is aligned with the new structural requirements decided by ISO CASCO (8 chapters instead of 15 in ISO/IEC Guide 65) 1. 2. Normative references 3. Terms and definitions 4. General requirements 5. Structural requirements 6. Resource requirements 7. Process requirements 8. Page 11 2012 -09 -26 Scope Management system requirements

Content of ISO/IEC Guide 65 to ISO/IEC 17065 (2) Ø The obligatory requirements of the ISO/PAS are included in ISO/IEC 17065 1. ISO/PAS 17001 on Impartiality included in clause 4. 2 2. ISO/PAS 17002 on Confidentiality included in clause 4. 5 3. ISO/PAS 17003 on Complaints and appeals included in clause 7. 13 4. ISO/PAS 17004 on Disclosure of information included in clause 4. 6 5. ISO/PAS 17005 on Use of management systems included in clause 8 * The PAS requirements may also be addressed in other parts of the standards than the ones listed above Page 12 2012 -09 -26

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (1) The scope in ISO/IEC 17065 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 Page 13 2012 -09 -26

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (2) Certification schemes are mandatory part of product certification (ISO/IEC 17065). 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” Page 14 2012 -09 -26

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (3) Ø The definition chapter is considerably improved by definitions on consultancy evaluation product, process, service certification requirement, product requirement certification scheme, certification scheme owner scope of certification body impartiality Page 15 2012 -09 -26

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/IEC 17065 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 Page 16 2012 -09 -26

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/IEC 17065, 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 Page 17 2012 -09 -26

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

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/IEC 17065 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 Page 19 2012 -09 -26

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 Page 20 2012 -09 -26

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

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

ISO/IEC 17065: 2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but more detailed description in: Clause 4. 1 Legal and contractual matters Page 23 2012 -09 -26 • legal responsibility (4. 1. 1) • certification agreement and use of licenses certificates (4. 1. 2) • marks of conformity (4. 1. 3)

ISO/IEC 17065: 2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Significant improvements related to ISO/IEC Guide 65: Clause 4. 2 Impartiality Page 24 2012 -09 -26 • 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

ISO/IEC 17065: 2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 4. 3 Liability and financing Clause 4. 4 Non-discriminatory conditions Clause 4. 5 Confidentiality Clause 4. 6 Publicly available informations Page 25 2012 -09 -26 No essential changes related to ISO/IEC Guide 65 but partially more detailed description

ISO/IEC 17065: 2012 5. Structural requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 5. 1 Organization Clause 5. 2 Safeguarding Impartiality No essential changes related to ISO/IEC Guide 65 but partially more detailed description 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. Page 26 2012 -09 -26

ISO/IEC 17065: 2012 6. Resource requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 6. 1 Personnel No essential changes related to ISO/IEC Guide 65 but partially more detailed description. 6. 2 Evaluation resources 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. Page 27 2012 -09 -26

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7. 1 Scheme 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 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. Page 28 2012 -09 -26

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7. 4 Evaluation Page 29 2012 -09 -26 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

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7. 5 Review Page 30 2012 -09 -26 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

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65. Clause 7. 6 Decision Page 31 2012 -09 -26 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-eyesprincipal and can not be outsourced (subcontracted).

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7. 7 Documentation Clause 7. 8 Directory Page 32 2012 -09 -26 No essential changes related to ISO Guide 65 but partially more detailed description

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 7. 9 Surveillance No essential changes related to ISO Guide 65 but partially more detailed description. Clause 7. 10 Changes 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). Clause 7. 11 Status Improvement related to ISO Guide 65 by more detailed description of termination, reduction, suspension or withdrawal of certification. Page 33 2012 -09 -26

ISO/IEC 17065: 2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. 12 Records 7. 13 Complaints / Appeals Page 34 2012 -09 -26 No essential changes related to ISO/IEC Guide 65 Alignment with ISO PAS 17003

ISO/IEC 17065: 2012 ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 8. Managementsystem Page 35 2012 -09 -26 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.

ISO/IEC 17065: 2012 ISO/IEC 17065 and relation to ISO/IEC Guide 65 Principles (Annex A) 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. Page 36 2012 -09 -26

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 Page 37 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (2) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 1. 1/1 st paragraph/competent 1 1. 1/1 st paragraph/third-party 1 3 rd sentence/3. 12 1. 1/1 st paragraph/certification system 1. 1/2 nd paragraph/product, process, service 1. 2 3. 9/7. 1. 1 System → scheme 1 1 st sen. /3. 4/3. 5/3. 6/Annex B 7. 1. 1 Note 1 and 2 3. 1 Supplier → client 4. 1. 1 4. 4. 1. 2 4. 4. 2/4. 4. 3 4. 1. 3/1 st and 2 nd sentence 7. 1. 2 4. 1. 3/3 rd sentence 7. 1. 3 4. 1. 4 4. 4. 4 4. 2 a) 4. 2 Page 38 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (3) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 4. 2 b) 7. 6. 1 4. 2 c) 5. 1. 3 4. 2 d) 4. 1. 1 4. 2 e) 1 st sentence 5. 1. 1 4. 2 e) 2 nd sentence 4. 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 Page 39 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (4) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 4. 2 m) 4. 2. 2, 4. 2. 5 4. 2 n) 5. 1. 4 4. 2 o)/related bodies 4. 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 sentence 7. 4. 4 4. 3/1 st paragraph/2 nd sentence 7. 1. 2 4. 3/2 nd paragraph 6. 2. 1 4. 4 6. 2. 2 4. 4 Note 2 7. 4. 5 Page 40 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (5) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 4. 4 Note 3 7. 4. 5 Note 4. 5 8 4. 5. 3 a) 8. 2. 1 4. 5. 3 c) 6. 1. 2. 2 4. 5. 3 d) 5. 1. 2 ISO/IEC 17065 requirement applies only to individuals in the certification process 4. 5. 3 e) 5. 1. 2 4. 5. 3 f) 8. 5 ISO/IEC 17065 requirement more focused 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) Page 41 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (6) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 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. 1 17000 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. 1 8. 6 4. 7. 2 8. 5 4. 8. 1 b) 4. 6 a) 4. 8. 1 c) 4. 6 a) Page 42 2012 -09 -26 Remarks

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (7) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 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. 2/8. 3 4. 9 7. 12/8. 4 4. 10 4. 5 4. 10. 1 6. 1. 1. 3 5. 1. 1 6. 1. 1. 2 5. 1. 2 6. 1. 2. 1 d)/8. 2. 5 5. 2. 1 6. 1. 2. 1 5. 2. 2 6. 1. 3 Page 43 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (8) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 5. 2. 3 6. 1. 2. 2 6 7. 10 7 7. 13 8. 1. 1 4. 6 a), 4. 6 c 8. 1. 2 4. 1. 2. 2 8. 1. 3 4. 6 a)/7. 1. 3 8. 2 7. 2, 7. 3 8. 2. 1/application form 7. 2 Note 2 9. 1 7. 3. 1 – 7. 3. 4 9. 2 7. 4. 1 9. 3 7. 4. 2 Page 44 2012 -09 -26

Cross reference ISO/IEC Guide 65: 1996 to ISO/IEC 17065: 2012 (9) ISO/IEC Guide 65: 1996 ISO/IEC 17065: 2012 Remarks 9. 4 7. 4. 3 10 7. 4. 4 11 7. 4. 9 11 b)/nonconformities 7. 4. 6 12. 1 7. 6. 2 12. 2 7. 6. 1 12. 3 7. 7 12. 4 7. 10 13 7. 9 13. 2 4. 1. 2. 2 k)/7. 10 14 4. 1. 3 15 4. 1. 2. 2 j) Page 45 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (1) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 1 1. 1/1 st paragraph/competent 1 1 st sen. /3. 4/3. 5/3. 6/Annex B 1. 1/2 nd paragraph/product, process, service 1 3 rd sentence/3. 12 1. 1/1 st paragraph/third-party 3. 1 3. 4 1. 1/2 nd paragraph/product, process, service 3. 5 1. 1/2 nd paragraph/product, process, service 3. 6 1. 1/2 nd paragraph/product, process, service 3. 9/7. 1. 1/1 st paragraph/certification system 4. 1. 1 4. 2 d) 4. 1. 2. 1 4. 2 g 4. 1. 2. 2 8. 1. 2, 8. 2. 1 Page 46 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (2) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 4. 1. 3 14 4. 2 a; 4. 2 e; 4. 2 m; 4. 2 o 4. 3. 1 4. 2 h 4. 3. 2 4. 2 i) 4. 4. 1. 1 4. 4. 2/4. 4. 3 4. 1. 2 4. 4. 4 4. 1. 4 4. 5 4. 10 4. 6 a) 4. 8. 1 b) 4. 6 a) 4. 8. 1 c) 4. 6 a) 8. 1. 1 Page 47 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (3) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 4. 6 a)/7. 1. 3 8. 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. 1 4. 2 e) 1 st sentence 5. 1. 2 4. 2 l) 5. 1. 2 4. 5. 3 d) 5. 1. 2 4. 5. 3 e) 17065 requirement more focused 5. 1. 3 4. 2 c) 5. 1. 4 4. 2 n) Page 48 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (4) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 5. 2 4. 2 e) 2 nd sentence 6. 1. 1. 1/6. 1. 1. 2 4. 2 j) 6. 1. 1. 2 5. 1. 1 6. 1. 1. 3 4. 10. 1 6. 1. 2. 1 4. 5. 3 i) 6. 1. 2. 1 5. 2. 1 6. 1. 2. 1 d)/8. 2. 5 5. 1. 2 6. 1. 2. 2 4. 5. 3 c) 17065 requirement applies only to individuals in the certification process 5. 2. 3 6. 1. 3 5. 2. 2 6. 2. 1 4. 3/2 nd paragraph 6. 2. 2 4. 4 Page 49 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (5) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 6. 2. 2. 4 d) 4. 5. 3 j) 7. 1. 1/1 st paragraph/certification system 7. 1. 1 Note 1 and 2 1. 2 7. 1. 2 4. 1. 3/1 st and 2 nd sentence 7. 1. 2 4. 3/1 st paragraph/2 nd sentence 7. 1. 3 4. 1. 3/3 rd sentence 7. 1. 3 8. 1. 3 Page 50 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (6) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 7. 2 8. 2 7. 2 Note 2 8. 2. 1/application form 7. 3 9. 1 7. 4. 1 9. 2 7. 4. 2 9. 3 7. 4. 3 9. 4 7. 4. 4 4. 3/1 st paragraph/1 st sentence 7. 4. 4 10 7. 4. 5 4. 4 Note 2 7. 4. 5 Note 4. 4 Note 3 7. 4. 6 11 b)/nonconformities Page 51 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (7) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 7. 4. 9 11 7. 6. 1 4. 2 b) 7. 6. 1 12. 2 7. 6. 2 4. 2 f) 7. 6. 2 12. 1 7. 7 12. 3 7. 8 4. 8. 1 g) 7. 9 13 7. 10 4. 6. 2 c) 7. 10 6 7. 10 12. 4 7. 10 13. 2 Page 52 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (8) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 7. 11 4. 5. 3 l) 1), 4. 6. 1; 4. 6. 2 a; 4. 6. 2 b 7. 12/8. 4 4. 9 7. 13 4. 2 p) 7. 13 4. 5. 3 m) 7. 13 7 8 4. 2 k) 8. 2. 4 4. 2 l) 8. 2. 5 4. 5. 3 h) / 5. 1. 2 8. 2/8. 3 4. 8. 2 8. 3 4. 5. 3 g) Page 53 2012 -09 -26

Cross reference ISO/IEC 17065: 2012 to ISO/IEC Guide 65: 1996 (8) ISO/IEC 17065: 2012 ISO/IEC Guide 65: 1996 8. 3 4. 5. 3 l) 2) 8. 4 4. 9 8. 5 4. 5. 3 f) 8. 5 4. 7. 2 8. 6 4. 5. 3 n) 8. 6 4. 7. 1 8. 7 4. 5. 3 k) Annex B 1. 1/2 nd paragraph/product, process, service Page 54 2012 -09 -26

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) Page 55 2012 -09 -26

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

Relation between certification body and scheme owner Scheme owner runs a scheme Guidelines for schemes are given in ISO/IEC 17067 Stakeholder 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, …. . Page 57 2012 -09 -26 Requirements for certification bodies are given in ISO/IEC 17065 ISO/IEC 17030 for the labels and their use

Examples of resources used for testing, inspection and auditing Certification body All those examples are covered in Clauses 6 of ISO/IEC 17065 Page 58 2012 -09 -26

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

Examples: how a CB can be positioned in a bigger organisation Holding Legal Entity 1 Div. 1. 1 Business Area 1. 1. 1 Reg. 1. 1 Legal Entity 2 Reg. 1. 2 Legal Entity 3 Legal Entity 4 CB Legal Entity 3. 1 Div. 4. 1 Dep. 2. 1 Legal Entity 3. 2 Div. 4. 2 Business Area. 1. 1. 2 This shows possible position of a CB within a bigger organisation Page 60 2012 -09 -26 Div. 4. 3 Ext.

Example of possible arrangement for Organizational Control Certification Body 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 Related company Person/employee Work contract This relates to Clause 7. 6. 4 of ISO/IEC 17065. This is one possibility for organisational control among many Page 61 2012 -09 -26

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

Process steps / requirements • 7. 1 General • 7. 2 Application • 7. 3 Application review • 7. 4 Evaluation • 7. 5 Review • 7. 6 Certification decision • 7. 7 Certification documentation • 7. 8 Directory of certified products • 7. 9 Surveillance • 7. 10 Changes affecting certification • 7. 11 Termination, reduction, suspension or withdrawal of certification • 7. 12 Records • 7. 13 Complaints and appeals Page 63 2012 -09 -26

Maintenance group (1) Mandate 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. 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. Page 64 2012 -09 -26

Maintenance group (2) Members Mr. Sumio Asada JISC (Japan) Ms. Andrea Barroso Melo Monteiro de Queiroz ABNT (Brazil) Mr. Alister Dalrymple AFNOR (France) Ms. Yunhua Chen SAC (China) Mr. Ian Cleare BSI (United Kingdom) Mr. Graeme Drake SA (Australia) Mr. Reinaldo Figueiredo ANSI (USA) Mr. Steve Keeling SA (Australia) Mr. Pedro Loste AENOR (Spain) Mr. Leif Madsen DS (Denmark) Mr. Paul Moliski IAF Mr. Keith Mowry ANSI (USA) Mr. Christian Priller (Convenor WG 29) DIN (Germany) Mr Jaap Prummel NEN (Netherlands) Mr. Lorenz Roggli SNV (Switzerland) – ILAC Mr. Hinrich Schaub ON (Austria) Mr. Thomas Facklam IAF Mr. Hanspeter Ischi SNV (Switzerland) – ILAC alternate Mr. Heribert Schorn (DIN – Germany) Mr. Alan Squirrell ILAC Mr. Pierre de Ruvo IEC Page 65 2012 -09 -26

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 Page 66 2012 -09 -26