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 MacCurtain 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
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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 â‚Ź, about 2000 Notified Bodies 974 accredited certification bodies in Europe (source: European Co-operation
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
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 Page 4 2012-09-26
USA 120 Accredited Certification Bodies
Product, Process and Service Certification (1)
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Product, Process and Service Certification (2)
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Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 date
activity
2007-04
1st WG 29 meeting – definition of scope and structure of revision
WD1
2007-09
1st DG meeting
WD2
2008-04
2nd DG meeting
WD3
2008-04
2nd WG 29 meeting
WD4
2008-10
3rd DG meeting
WD5
2009-03
4th DG meeting
WD6
2009-06
3rd WG 29 meeting
CD1
2009-07
CD out for ballot
2010-03
Change of Convenor Mario Wittner > Christian Priller
2010-04
4th WG 29 meeting
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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
5th DG WG 29 meeting
2010-08
CD2 out for ballot for two months
2011-01
6th DG meeting
2011-02
5th WG 29 meeting in conjunction with WG 32
2011-05
DIS out for ballot
2012-01
7th DG meeting (Geneva)
2012-02
6th WG 29 meeting (Munich)
2012-04
FDIS out for vote
2012-07
FDIS approved
2012-09
Publication
Page 8 2012-09-26
Participation
Results ballot
CD2 91% approval 570 comments submitted
DIS
35 88% approval 440 comments submitted
FDIS
30
95% approval in ISO and 100% in IEC IS
Timeline of Revision ISO/IEC Guide 67 to ISO/IEC 17067 Date
Activity WG 32
Output
Participation
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
12
2011-11
CD out for ballot
2012-04
5th WG meeting
2012-06
DIS out for ballot
2013-02
6th WG meeting
Q2 2013
FDIS out for ballot
Q3 2013
IS out
Status of ISO/IEC 17067
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Results (comments/voting)
88% approval DIS
FDIS
15
Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 ISO IEC 17065
ISO IEC Guide 65
Maintain Maintainthe theproven proven parts partsof ofGuide Guide65 65 Improve Improvewhere where necessary necessary
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Content of ISO/IEC Guide 65 to ISO/IEC 17065 (1) ďƒ˜ The content is aligned with the new structural requirements decided by ISO CASCO (8 chapters instead of 15 in ISO/IEC Guide 65)
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Content of ISO/IEC Guide 65 to ISO/IEC 17065 (2) ďƒ˜ 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 Page 12 2012-09-26
Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (1)
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (2)
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (3) ďƒ˜ The definition chapter is considerably improved by definitions on
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (4)
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (5)
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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
evaluation
– review – attestation
Decision and insuance of certificate if relevant
– surveillance The functions “selection” and “determination” are in 17065 combined as function “evaluation”
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Changes of revision ISO Guide 65 to ISO/IEC 17065 (7)
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (8)
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Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (9) ďƒ˜ Detailed presentation of the most important clauses of the new ISO/IEC17065:2012
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ISO/IEC 17065:2012
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 3. Terms and definitions
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ISO/IEC 17065:2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 4.1 Legal and contractual matters
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ISO/IEC 17065:2012 4. General requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 4.2 Impartiality
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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 Clause 4.4 Non-discriminatory conditions Clause 4.5 Confidentiality Clause 4.6 Publicly available informations Page 25 2012-09-26
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
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.
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ISO/IEC 17065:2012 6. Resource requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
6.1 Personnel
6.2 Evaluation resources
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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.
ISO/IEC 17065:2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.1 Scheme
Clause 7.2/7.3 Application
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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.
ISO/IEC 17065:2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.4 Evaluation
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ISO/IEC 17065:2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.5 Review
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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
Clause 7.6 Decision
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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
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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
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.
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ISO/IEC 17065:2012 7. Process Requirements ISO/IEC 17065 and relation to ISO/IEC Guide 65
7.12 Records
7.13 Complaints / Appeals
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Alignment with ISO PAS 17003
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)
Process and services (Annex B)
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The informative Annex B provides explanations for application of this standard for certification of processes and services.
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (1)
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Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (2) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
1.1/1st paragraph/competent
1
1.1/1st paragraph/third-party
1 3rd sentence/3.12
1.1/1st paragraph/certification system 1.1/2nd paragraph/product, process, service 1.2
3.9/7.1.1
3.1
3.1
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
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Remarks
System → scheme
1 1st sen./3.4/3.5/3.6/Annex B 7.1.1 Note 1 and 2 Supplier → client
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (3) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
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Remarks
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (4) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
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Remarks
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (5) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
4.5.3 e)
5.1.2
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)
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Remarks
ISO/IEC17065 requirement applies only to individuals in the certification process
ISO/IEC17065 requirement more focused
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
4.6.2 c)
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
4.7.1
8.6
4.7.2
8.5
4.8.1 b)
4.6 a)
4.8.1 c)
4.6 a)
4.6.2 a) and b)
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Remarks
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (7) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
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Remarks
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (8) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
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Remarks
Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (9) ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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)
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Remarks
Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (1) ISO/IEC 17065:2012
ISO/IEC Guide 65:1996
1
1.1/1st 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
3.1
3.4
1.1/2nd paragraph/product, process, service
3.5
1.1/2nd paragraph/product, process, service
3.6
1.1/2nd paragraph/product, process, service
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
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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
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
4.1.2
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
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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) 1st 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)
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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) 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)
6.1.2.1
5.2.1
6.1.2.1 d)/8.2.5
5.1.2
6.1.2.2 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
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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
1.1/1st paragraph/certification system
7.1.1 Note 1 and 2
1.2
7.1.2
4.1.3/1st and 2nd sentence
7.1.2
4.3/1st paragraph/2nd sentence
7.1.3
4.1.3/3rd sentence
7.1.3
8.1.3
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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
4.3/1st paragraph/1st 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
4.8.2
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
1.1/2nd paragraph/product, process, service
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Back up slides
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History and Relationship
1990
1980 ISO Guide 40 1983
2000 ISO Guide 65 1996
ISO Guide 23 1982
ISO Guide 23 1982
ISO Guide 67 1981
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 Schemeowner owner runs runsaascheme scheme Guidelines Guidelinesfor for schemes schemesare are given giveninin ISO/IEC ISO/IEC17067 17067
Stakeholder manufactorer, operator,
Certification Body
deliverer of a
and
product, process or services
Conformity assessment
Customer Scheme owner can be the certification body, governmenal authority, trade association, group of CB‘S, ‌.. Page 57 2012-09-26
Requirements Requirements for forcertification certification bodies bodies are are given givenininISO/IEC ISO/IEC 17065 17065 ISO/IEC ISO/IEC17030 17030 for forthe thelabels labels and andtheir theiruse 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
All those examples are covered in Clause 6 of ISO/IEC 17065
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Examples: how a CB can be positioned in a bigger organisation
This shows possible position of a CB within a bigger organisation Page 60 2012-09-26
Example of possible arrangement for Organizational Control
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 Page 61 2012-09-26
Functional Approach The functional approach is described in ISO/IEC 17000 (left part of the chart below)
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 Page 62 2012-09-26
Process steps / requirements
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Maintenance group (1) Mandate
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