Ppt presentation 17065

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 [email protected]

ISO CASCO Secretary ISO CASCO Convenor WG 29Sean 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

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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.

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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)

International levelIEC CB Scheme:74 National Certification Bodies382 CB Testing Laboratories45 Satellite Laboratories2800 Manufacturer's Testing Laboratories70'000 CB Test Certificates issues in 2011

Asia

JapanJIS-mark : 25 certification bodiesJAS-mark: 142 certification bodiesPSE-mark: 10 certification bodiesPSC-mark : 9 certification bodiesPAL : 13 certification bodiesChina:35 accredited Certification Bodies10 Certification Bodies response for China Compulsory Certification (CCC)50,728 companies with 280,000 certificates for CCC

New Zealand/Australia36 certification bodies for product certification70 product certification schemes delivered by 36 accredited bodiesBrasil

70 accredited Certification Bodies

USA120 Accredited Certification Bodies

Germany:GS-mark91 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

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date activity output Participants Results ballot2007-04 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

2008-04 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% approval1040 comments submitted

2010-03 Change of Convenor Mario Wittner > Christian Priller

2010-04 4th WG 29 meeting 43


date activity output Participation Results ballot2010-06 5th DG WG 29 meeting CD2

2010-08 CD2 out for ballot for two months 91% approval570 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% approval440 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

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Status of ISO/IEC 17067Date Activity WG 32 Output Participation Results (comments/voting)

2010-021st 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 88% approval

2012-04 5th WG meeting DIS 15

2012-06 DIS out for ballot

2013-02 6th WG meeting FDIS

Q2 2013 FDIS out for ballot

Q3 2013 IS out

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

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Maintain the proven parts of Guide 65

Improve where necessary

ISO IEC Guide 65 ISO IEC 17065

Content of ISO/IEC Guide 65 to ISO/IEC 17065 (1)

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The content is aligned with the new structural requirements decided by ISO CASCO (8 chapters instead of 15 in ISO/IEC Guide 65)

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

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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

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (1)

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The definition chapter is considerably improved by definitions on


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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– attestation– surveillance

The functions “selection” and “determination” are in 17065 combined as function “evaluation”

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evaluation

Decision and insuance of certificate if relevant

Changes of revision ISO Guide 65 to ISO/IEC 17065 (7)

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Detailed presentation of the most important clauses of the new ISO/IEC17065:2012

ISO/IEC 17065:2012

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Clause 3. Terms anddefinitions

ISO/IEC 17065 and relation to ISO/IEC Guide 65

ISO/IEC 17065:2012

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Clause 4.1 Legal and

contractual matters


4. General requirements

ISO/IEC 17065:2012

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Clause 4.2 Impartiality



ISO/IEC 17065:2012

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Clause 4.3 Liability and

financing


Clause 4.4 Non-discrimi-

natory conditions

Clause 4.5 Confidentiality

Clause 4.6 Publicly

available informations


ISO/IEC 17065:2012

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Clause 5.1 Organization


Clause 5.2 Safeguarding Impartiality

5. Structural requirements

Significant changes related to ISO/IEC Guide 65 by introducing a mechanism for safeguarding impartiality which can bea committee established by one or more CB’sa committee implemented by a scheme ownera governmental authority or an equivalent party.

ISO/IEC 17065:2012

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6.1 Personnel


6.2 Evaluationresources

6. Resource requirements

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

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Clause 7.1 Scheme


Clause 7.2/7.3 Application

7. Process Requirements

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

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Clause 7.4 Evaluation



ISO/IEC 17065:2012

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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

ISO/IEC 17065:2012

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Clause 7.6 Decision



ISO/IEC 17065:2012

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Clause 7.7 Documentation


Clause 7.8 Directory


ISO/IEC 17065:2012

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Clause 7.9 Surveillance


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.

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).

ISO/IEC 17065:2012

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7.12 Records


7.13 Complaints / Appeals


Alignment with ISO PAS 17003

ISO/IEC 17065:2012

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Clause 8. Management-

system


ISO/IEC 17065:2012

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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.

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 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 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

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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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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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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) 5.1.2 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)

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ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 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) 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)

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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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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

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

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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



3.9/7.1.1 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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4.1.3 144.2 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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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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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 4.5.3 c) 17065 requirement applies only to individuals in the certification process

6.1.2.2 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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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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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


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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


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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)



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

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1990 2000 20101980

ISO Guide 401983

ISO Guide 231982

ISO Guide 671981

ISO Guide 651996

ISO Guide 231982

ISO Guide 671981

ISO/IEC 17065

ISO/IEC 170672013

until than existing ISO

Guide 23 and 67

2012

Relation between certification body and scheme owner

Scheme owner runs a scheme

Guidelines for schemes are

given inISO/IEC 17067

Requirements for certification

bodies are given in ISO/IEC

17065

Stakeholder

manufactorer,operator,

deliverer of aproduct, process or

services

Certification Bodyand

Conformity assessment

Customer

Scheme owner can be the certification body, governmenal authority,trade association, group of CB‘S, …..

ISO/IEC 17030 for the labels and their use

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Examples of resources used for testing, inspection and auditing

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

Certification body

Examples of Resources Personnel

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

Examples: how a CB can be positioned in a bigger organisation

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This shows possible position of a CB within a bigger organisation

Example of possible arrangement for Organizational Control

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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

Functional Approach

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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

The functional approach is described in ISO/IEC 17000 (left part of the chart below)

Process steps / requirements

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Maintenance group (1)

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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.

Mandate

Maintenance group (2) Members

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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

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

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