Presentation on the new standard ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products, processes and services Presentation on the new standard 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 ISO CASCO Convenor WG 29 Sean MacCurtain Christian Priller 2012-09-26

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 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. 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 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 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 2012-09-26

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

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

Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 date activity output Participants Results ballot 2007-04 1st WG 29 meeting – definition of scope and structure of revision  WD1 30 2007-09 1st DG meeting WD2 2008-04 2nd DG meeting WD3  2nd WG 29 meeting WD4 35 2008-10 3rd DG meeting WD5 2009-03 4th DG meeting WD6 2009-06 3rd 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 4th WG 29 meeting 43 2012-09-26

Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 date activity output Participation Results ballot 2010-06 5th DG WG 29 meeting CD2 2010-08 CD2 out for ballot for two months   91% approval 570 comments submitted 2011-01 6th DG meeting 2011-02 5th WG 29 meeting in conjunction with WG 32 DIS 35 2011-05 DIS out for ballot 88% approval 440 comments submitted 2012-01 7th DG meeting (Geneva) 2012-02 6th 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 Publication IS 2012-09-26

1st WG 32 meeting – definition of scope and structure of revision Timeline of Revision ISO/IEC Guide 67 to ISO/IEC 17067 Status of ISO/IEC 17067 Date Activity WG 32 Output Participation Results (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 3rd WG meeting WD2 15 2011-10 4th WG meeting CD 2011-11 CD out for ballot   88% approval 2012-04 5th WG meeting DIS 2012-06 DIS out for ballot 2013-02 6th WG meeting FDIS Q2 2013 FDIS out for ballot Q3 2013 IS out 2012-09-26

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

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

Content of ISO/IEC Guide 65 to ISO/IEC 17065 (2) The obligatory requirements of the ISO/PAS are included in ISO/IEC17065 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 2012-09-26

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

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

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (3) 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 certification body impartiality 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/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

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

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” evaluation Decision and insuance of certificate if relevant 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/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

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

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

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 Clause 3. Terms and definitions 2012-09-26

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: legal responsibility (4.1.1) certification agreement and use of licenses certificates (4.1.2) marks of conformity (4.1.3) Clause 4.1 Legal and contractual matters 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 4. General requirements 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 Clause 4.2 Impartiality 2012-09-26

ISO/IEC 17065:2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 4.3 Liability and financing 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 2012-09-26

ISO/IEC 17065:2012 5. Structural requirements 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 5.1 Organization 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. Clause 5.2 Safeguarding Impartiality 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 6. Resource requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO/IEC Guide 65 but partially more detailed description. 6.1 Personnel 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. 6.2 Evaluation resources 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. Process Requirements 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 7.1 Scheme 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. Clause 7.2/7.3 Application 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. Process Requirements 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 Clause 7.4 Evaluation 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 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 Clause 7.5 Review 2012-09-26

ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. Process Requirements 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). Clause 7.6 Decision 2012-09-26

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

ISO/IEC 17065 and relation to ISO/IEC Guide 65 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65 No essential changes related to ISO Guide 65 but partially more detailed description. Clause 7.9 Surveillance 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 7.10 Changes Clause 7.11 Status Improvement related to ISO Guide 65 by more detailed description of termination, reduction, suspension or withdrawal of certification. 2012-09-26

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

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. Clause 8. Management- system 2012-09-26

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. Principles (Annex A) Process and services (Annex B) The informative Annex B provides explanations for application of this standard for certification of processes and services. 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 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (2) Remarks 1.1/1st paragraph/competent 1   1.1/1st paragraph/third-party 1 3rd sentence/3.12 1.1/1st paragraph/certification system 3.9/7.1.1 System → scheme 1.1/2nd paragraph/product, process, service 1 1st sen./3.4/3.5/3.6/Annex B 1.2 7.1.1 Note 1 and 2 3.1 Supplier → client 4.1.1 4.4.1 4.1.2 4.4.2/4.4.3 4.1.3/1st and 2nd sentence 7.1.2 4.1.3/3rd sentence 7.1.3 4.1.4 4.4.4 4.2 a) 4.2 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (3) Remarks 4.2 b) 7.6.1   4.2 c) 5.1.3 4.2 d) 4.1.1 4.2 e) 1st sentence 5.1.1 4.2 e) 2nd 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 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (4) 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 4.3/1st paragraph/1st sentence 7.4.4 4.3/1st paragraph/2nd sentence 7.1.2 4.3/2nd paragraph 6.2.1 4.4 6.2.2 4.4 Note 2 7.4.5 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (5) 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  ISO/IEC17065 requirement applies only to individuals in the certification process 4.5.3 d) 5.1.2 4.5.3 e)  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

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (6) Remarks 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) 4.6.2 c) 7.10 4.7.1 4.7.2 8.5 4.8.1 b) 4.6 a) 4.8.1 c) 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (7) 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 8.2/8.3 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 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (8) 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 2012-09-26

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (9) 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) 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (1) 1.1/1st paragraph/competent 1 1st sen./3.4/3.5/3.6/Annex B 1.1/2nd paragraph/product, process, service 1 3rd sentence/3.12 1.1/1st paragraph/third-party 3.1 3.4 3.5 3.6 3.9/7.1.1 1.1/1st 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 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (2) 4.1.3 14 4.2 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 4.1.1 4.4.2/4.4.3 4.1.2 4.4.3 4.4.4 4.1.4 4.5 4.10 4.6 a) 4.8.1 b) 4.8.1 c) 8.1.1 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (3) 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) 1st sentence 5.1.2 4.2 l) 4.5.3 d) 4.5.3 e) 17065 requirement more focused 5.1.3 4.2 c) 5.1.4 4.2 n) 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (4) 5.2 4.2 e) 2nd 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) 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 4.3/2nd paragraph 6.2.2 4.4 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (5) 4.5.3 j) 7.1.1 1.1/1st paragraph/certification system 7.1.1 Note 1 and 2 1.2 7.1.2 4.1.3/1st and 2nd sentence 4.3/1st paragraph/2nd sentence 7.1.3 4.1.3/3rd sentence 8.1.3 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (6) 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 4.3/1st paragraph/1st sentence 10 7.4.5 4.4 Note 2 7.4.5 Note 4.4 Note 3 7.4.6 11 b)/nonconformities 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (7) 7.4.9 11 7.6.1 4.2 b) 12.2 7.6.2 4.2 f) 12.1 7.7 12.3 7.8 4.8.1 g) 7.9 13 7.10 4.6.2 c) 6 12.4 13.2 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (8) 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) 4.5.3 m) 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) 2012-09-26

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (8) 8.3 4.5.3 l) 2) 8.4 4.9 8.5 4.5.3 f) 4.7.2 8.6 4.5.3 n) 4.7.1 8.7 4.5.3 k) Annex B 1.1/2nd paragraph/product, process, service 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) 2012-09-26

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

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

Examples of resources used for testing, inspection and auditing Certification body 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 2012-09-26

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

Examples: how a CB can be positioned in a bigger organisation Holding Legal Entity 1 Div. 1.1 Business Area 1.1.1 Business Area . 1.1.2 Reg. 1.1 Reg. 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 2012-09-26

Example of possible arrangement for Organizational Control 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 2012-09-26

Insuance of a certificate after decision Functional Approach The functional approach is described in ISO/IEC 17000 (left part of the chart below) … 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 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 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. 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 Mr. Pedro Loste AENOR (Spain) Mr. Leif Madsen DS (Denmark) Mr. Paul Moliski IAF Mr. Keith Mowry 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 Mr. Hanspeter Ischi SNV (Switzerland) – ILAC alternate Mr. Heribert Schorn (DIN – Germany) Mr. Alan Squirrell ILAC Mr. Pierre de Ruvo IEC 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 2012-09-26