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ISO/IEC 17065:2012

Conformity assessment Requirements for bodies certifying products, processes and services

Presentation on the new standard


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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


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ISO CASCO Convenor WG 29 Christian Priller

Table of content
Importance / Impact of product certification for global trade 4

Product, Process and Service Certification


Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 Content of ISO/IEC Guide 65 to ISO/IEC 17065 Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 ISO/IEC 17065:2012 Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 Back-up slides: examples
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5
7 10 11 13 22 37 46 55

Examples - Importance and Impact of product certification for global trade


An unknown number of sectors, regulators, schemes and CBs 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 Brasil


70 accredited Certification Bodies 36 certification bodies for product certification 70 product certification schemes delivered by 36 accredited bodies

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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
2007-04 2007-09 2008-04

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

2nd WG 29 meeting 3rd DG meeting


4th DG meeting 3rd WG 29 meeting CD out for ballot Change of Convenor Mario Wittner > Christian Priller 4th WG 29 meeting

WD4 WD5
WD6 CD1

35

37 78% approval 1040 comments submitted

43

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Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065


date
2010-06 2010-08 2011-01 2011-02 2011-05 2012-01 2012-02 2012-04 2012-07 2012-09
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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

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 Results (comments/voting)

Status of ISO/IEC 17067


2010-02 2010-09 2011-02 2011-10 2011-11 2012-04 2012-06 2013-02 Q2 2013 Q3 2013
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1st WG 32 meeting definition of scope and structure of revision


2nd WG meeting 3rd WG meeting 4th WG meeting CD out for ballot 5th WG meeting DIS out for ballot 6th WG meeting FDIS out for ballot IS out

WD0 WD1 WD2 CD

12 10 15 12 88% approval

DIS

15

FDIS

Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065


ISO IEC Guide 65 ISO IEC 17065

Maintain the proven parts of Guide 65 Improve where necessary

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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)

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Content of ISO/IEC Guide 65 to ISO/IEC 17065 (2)


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
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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)


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 review evaluation

attestation
surveillance

Decision and insuance of certificate if relevant

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)


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
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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 CBs

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

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

Clause 7.1 Scheme

Clause 7.2/7.3 Application

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

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

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

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 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.

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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

Alignment with ISO PAS 17003

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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)

Process and services (Annex B)

The informative Annex B provides explanations for application of this standard for certification of processes and services.

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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 1.1/1st paragraph/competent 1.1/1st paragraph/third-party 1.1/1st paragraph/certification system 1.1/2nd paragraph/product, process, service 1.2 ISO/IEC 17065:2012 1 1 3rd sentence/3.12 3.9/7.1.1 1 1st sen./3.4/3.5/3.6/Annex B System scheme Remarks

7.1.1 Note 1 and 2 3.1 4.4.1


4.4.2/4.4.3 7.1.2 7.1.3 4.4.4 4.2

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

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)
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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Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (4)


ISO/IEC Guide 65:1996 4.2 m) 4.2 n) 4.2 o)/related bodies 4.2 o) 1) 4.2 o) 2) 4.2 o) 3) 4.2 p) 4.3/1st paragraph/1st sentence 4.3/1st paragraph/2nd sentence 4.3/2nd paragraph 4.4 4.4 Note 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

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (5)


ISO/IEC Guide 65:1996 4.4 Note 3 4.5 4.5.3 a) 4.5.3 c) ISO/IEC 17065:2012 7.4.5 Note 8 8.2.1 6.1.2.2 ISO/IEC17065 requirement applies only to individuals in the certification process Remarks

4.5.3 d) 4.5.3 e) 4.5.3 f) 4.5.3 g) 4.5.3 h) 4.5.3 i) 4.5.3 j)

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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Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (6)


ISO/IEC Guide 65:1996 4.5.3 l) 4.5.3 l) 1) 4.5.3 l) 2) 4.5.3 m) 4.5.3 n) 4.6.1 4.6.2 a) and b) 4.6.2 c) 4.7.1 4.7.2 4.8.1 b) 4.8.1 c)
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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

Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 (7)


ISO/IEC Guide 65:1996 4.8.1 d) 4.8.1 e) 4.8.1 f) 4.8.1 g) 4.8.2 4.9 4.10 ISO/IEC 17065:2012 4.6 b) 4.6 c) 4.6 d) 7.8 8.2/8.3 7.12/8.4 4.5 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

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


ISO/IEC Guide 65:1996 5.2.3 6 7 8.1.1 8.1.2 8.1.3 8.2 8.2.1/application form 9.1 9.2 9.3 ISO/IEC 17065:2012 6.1.2.2 7.10 7.13 4.6 a), 4.6 c 4.1.2.2 4.6 a)/7.1.3 7.2, 7.3 7.2 Note 2 7.3.1 7.3.4 7.4.1 7.4.2 Remarks

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


ISO/IEC Guide 65:1996 9.4 10 11 11 b)/nonconformities 12.1 12.2 12.3 12.4 13 13.2 14 15
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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

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (1)


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

4.1.1 4.1.2.1 4.1.2.2


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4.2 d) 4.2 g 8.1.2, 8.2.1

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (2)


ISO/IEC 17065:2012 4.1.3 4.2 4.3.1 4.3.2 4.4.1 4.4.2/4.4.3 4.4.3 4.4.4 4.5 4.6 a) 4.6 a) 4.6 a)
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ISO/IEC Guide 65:1996

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

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (3)


ISO/IEC 17065:2012 4.6 a)/7.1.3 ISO/IEC Guide 65:1996 8.1.3

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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Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (4)


ISO/IEC 17065:2012 5.2 6.1.1.1/6.1.1.2 6.1.1.2 6.1.1.3 6.1.2.1 6.1.2.1 6.1.2.1 d)/8.2.5 6.1.2.2 6.1.2.2 6.1.3 6.2.1 6.2.2
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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

Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (5)


ISO/IEC 17065:2012 6.2.2.4 d) ISO/IEC Guide 65:1996 4.5.3 j)

7.1.1 7.1.1 Note 1 and 2


7.1.2 7.1.2 7.1.3 7.1.3

1.1/1st paragraph/certification system 1.2


4.1.3/1st and 2nd sentence 4.3/1st paragraph/2nd sentence 4.1.3/3rd sentence 8.1.3

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Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (6)


ISO/IEC 17065:2012 7.2 ISO/IEC Guide 65:1996 8.2

7.2 Note 2 7.3


7.4.1 7.4.2 7.4.3 7.4.4 7.4.4 7.4.5 7.4.5 Note 7.4.6

8.2.1/application form 9.1


9.2 9.3 9.4 4.3/1st paragraph/1st sentence 10 4.4 Note 2 4.4 Note 3 11 b)/nonconformities

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Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 (7)


ISO/IEC 17065:2012 7.4.9 7.6.1 7.6.1 7.6.2 7.6.2 7.7 7.8 7.9 7.10 7.10 7.10 7.10
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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

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


ISO/IEC 17065:2012 7.11 ISO/IEC Guide 65:1996 4.5.3 l) 1), 4.6.1; 4.6.2 a; 4.6.2 b

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


ISO/IEC 17065:2012 8.3 ISO/IEC Guide 65:1996 4.5.3 l) 2)

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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History and Relationship

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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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

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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Examples of resources used for testing, inspection and auditing


Certification body

All those examples are covered in Clauses 6 of ISO/IEC 17065

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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


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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
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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
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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.
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Maintenance group (2) Members


Mr. Sumio Asada Ms. Andrea Barroso Melo Monteiro de Queiroz Mr. Alister Dalrymple JISC (Japan) ABNT (Brazil) AFNOR (France)

Ms. Yunhua Chen


Mr. Ian Cleare Mr. Graeme Drake Mr. Reinaldo Figueiredo Mr. Steve Keeling Mr. Pedro Loste Mr. Leif Madsen Mr. Paul Moliski Mr. Keith Mowry Mr. Christian Priller (Convenor WG 29) Mr Jaap Prummel Mr. Lorenz Roggli Mr. Hinrich Schaub Mr. Thomas Facklam Mr. Hanspeter Ischi Mr. Heribert Schorn Mr. Alan Squirrell Mr. Pierre de Ruvo Page 65 2012-09-26

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

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
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