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Conformity assessment Requirements for bodies certifying products, processes and services
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
Table of content
Importance / Impact of product certification for global trade 4
5
7 10 11 13 22 37 46 55
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)
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USA
120 Accredited Certification Bodies
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activity
1st WG 29 meeting definition of scope and structure of revision 1st DG meeting 2nd DG meeting
output
WD1 WD2 WD3
Participants
30
Results ballot
2008-04 2008-10
2009-03 2009-06 2009-07 2010-03 2010-04
WD4 WD5
WD6 CD1
35
43
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activity
5th DG WG 29 meeting CD2 out for ballot for two months 6th DG meeting 5th WG 29 meeting in conjunction with WG 32 DIS out for ballot 7th DG meeting (Geneva) 6th WG 29 meeting (Munich) FDIS out for vote FDIS approved Publication
output
CD2
Participation
Results ballot
91% approval 570 comments submitted
DIS
FDIS
30
12 10 15 12 88% approval
DIS
15
FDIS
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attestation
surveillance
The functions selection and determination are in 17065 combined as function evaluation
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ISO/IEC 17065:2012
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ISO/IEC 17065:2012
4. General requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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ISO/IEC 17065:2012
4. General requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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ISO/IEC 17065:2012
4. General requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65 Clause 4.3 Liability and financing
ISO/IEC 17065:2012
5. Structural requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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 CBs
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ISO/IEC 17065:2012
6. Resource requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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.
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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.
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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ISO/IEC 17065:2012
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
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
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).
Improvement related to ISO Guide 65 by more detailed description of termination, reduction, suspension or withdrawal of certification.
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ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
7.12 Records
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ISO/IEC 17065:2012
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 8. Managementsystem
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ISO/IEC 17065:2012
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Principles (Annex A)
The informative Annex B provides explanations for application of this standard for certification of processes and services.
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3.1 4.1.1
4.1.2 4.1.3/1st and 2nd sentence 4.1.3/3rd sentence 4.1.4 4.2 a)
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Supplier client
4.2 b)
4.2 c) 4.2 d) 4.2 e) 1st sentence 4.2 e) 2nd sentence 4.2 f) 4.2 g) 4.2 h) 4.2 i) 4.2 j) 4.2 k)
7.6.1
5.1.3 4.1.1 5.1.1 4.2.4/5.2 7.6.2 4.1.2.1 4.3.1 4.3.2 6.1.1.1 8
4.2 l)
8.2.4 , 5.1.2
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ISO/IEC 17065:2012 4.2.2, 4.2.5 5.1.4 4.2.7/4.2.8 4.2.6 a) c) 4.2.6 d) and e) 4.2.3 7.13 7.4.4 7.1.2 6.2.1 6.2.2 7.4.5
Remarks
5.1.2 5.1.2 8.5 8.3 8.2.5 6.1.2.1 6.2.2.4 d) ISO/IEC17065 requirement more focused
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ISO/IEC 17065:2012 7 7.11, 7.7.3 8.3 7.13 8.6 17000 5.1; 17000 5.2; 7.6.2; 7.9.2; 7.11 17000 5.1; 17000 5.2; 7.6.2; 7.9.2; 7.11 7.10 8.6 8.5 4.6 a) 4.6 a)
Remarks
4.10.1 5.1.1
5.1.2 5.2.1 5.2.2
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6.1.1.3 6.1.1.2
6.1.2.1 d)/8.2.5 6.1.2.1 6.1.3
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ISO/IEC 17065:2012 7.4.3 7.4.4 7.4.9 7.4.6 7.6.2 7.6.1 7.7 7.10 7.9 4.1.2.2 k)/7.10 4.1.3 4.1.2.2 j)
Remarks
14
4.2 a; 4.2 e; 4.2 m; 4.2 o 4.2 h 4.2 i) 4.1.1 4.1.2 4.1.2 4.1.4 4.10 4.8.1 b) 4.8.1 c) 8.1.1
4.6 b) 4.6 c)
4.6 d) 5.1.1 5.1.2 5.1.2 5.1.2 5.1.3 5.1.4
4.8.1 d) 4.8.1 e)
4.8.1 f) 4.2 e) 1st sentence 4.2 l) 4.5.3 d) 4.5.3 e) 17065 requirement more focused 4.2 c) 4.2 n)
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ISO/IEC Guide 65:1996 4.2 e) 2nd sentence 4.2 j) 5.1.1 4.10.1 4.5.3 i) 5.2.1 5.1.2 4.5.3 c) 17065 requirement applies only to individuals in the certification process 5.2.3 5.2.2 4.3/2nd paragraph 4.4
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ISO/IEC Guide 65:1996 11 4.2 b) 12.2 4.2 f) 12.1 12.3 4.8.1 g) 13 4.6.2 c) 6 12.4 13.2
7.12/8.4 7.13
7.13 7.13 8 8.2.4 8.2.5 8.2/8.3 8.3 8.3
4.9 4.2 p)
4.5.3 m) 7 4.2 k) 4.2 l) 4.5.3 h) / 5.1.2 4.8.2 4.8.2 4.5.3 g)
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8.4 8.5
8.5 8.6 8.6 8.7 Annex B
4.9 4.5.3 f)
4.7.2 4.5.3 n) 4.7.1 4.5.3 k) 1.1/2nd paragraph/product, process, service
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Back up slides
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1980
ISO Guide 40 1983 ISO Guide 23 1982 ISO Guide 67 1981
1990
2000 ISO Guide 65 1996 ISO Guide 23 1982 ISO Guide 67 1981
2010
2012
ISO/IEC 17065 ISO/IEC 17067 2013 until than existing ISO Guide 23 and 67
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Stakeholder
manufactorer, operator, deliverer of a product, process or services
Certification Body
and Conformity assessment
Requirements for certification bodies are given in ISO/IEC 17065 ISO/IEC 17030 for the labels and their use
Customer Scheme owner can be the certification body, governmenal authority, trade association, group of CBS, ..
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Organizational Control is to supervise that the related company does not influence the person in its work for the CB
Work contract
This relates to Clause 7.6.4 of ISO/IEC 17065. This is one possibility for organisational control among many
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Functional Approach
The functional approach is described in ISO/IEC 17000 (left part of the chart below)
Evaluation
The right part of the chart (evaluation Insuance of certificate) is the terminology used in ISO/IEC 17065
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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.
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SAC (China)
BSI (United Kingdom) SA (Australia) ANSI (USA) SA (Australia) AENOR (Spain) DS (Denmark) IAF ANSI (USA) DIN (Germany) NEN (Netherlands) SNV (Switzerland) ILAC ON (Austria) IAF SNV (Switzerland) ILAC alternate (DIN Germany) ILAC IEC
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
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