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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.
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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.
International level Asia
IEC CB Scheme:
74 National Certification Bodies Japan
382 CB Testing Laboratories JIS-mark : 25 certification bodies
45 Satellite Laboratories JAS-mark: 142 certification bodies
2800 Manufacturer's Testing Laboratories PSE-mark: 10 certification bodies
70'000 CB Test Certificates issues in 2011 PSC-mark : 9 certification bodies
PAL : 13 certification bodies
Europe: China:
New Legilation Framework (NLF) over 20 35 accredited Certification Bodies
European Directives, Trade volume 1500 10 Certification Bodies response for China
mrd €, about 2000 Notified Bodies Compulsory Certification (CCC)
974 accredited certification bodies in Europe 50,728 companies with 280,000 certificates
(source: European Co-operation Accreditation) for CCC
Germany:
GS-mark New Zealand/Australia
91 bodies 36 certification bodies for product certification
70 product certification schemes delivered by 36
Brasil accredited bodies
70 accredited Certification Bodies
USA
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Product, Process and Service Certification
(1)
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Product, Process and Service
Certification (2)
non-
governmental governmental
organizations; authorities;
and
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Timeline of Revision ISO/IEC Guide 65 to
ISO/IEC 17065
date activity output Participants Results ballot
1st WG 29 meeting – definition of
2007-04 WD1 30
scope and structure of revision
2007-09 1st DG meeting WD2
78% approval
2009-07 CD out for ballot 1040 comments
submitted
Change of Convenor Mario
2010-03 Wittner > Christian Priller
2010-04 4th WG 29 meeting 43
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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
91% approval
2010-08 CD2 out for ballot for two months 570 comments
submitted
2012-09 Publication IS
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Timeline of Revision ISO/IEC Guide 67 to
ISO/IEC 17067
1st WG 32 meeting –
Status of ISO/IEC 17067
2010-02 definition of scope and
structure of revision
WD0 12
Q3 2013 IS out
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Purpose of Revision ISO/IEC Guide 65 to
ISO/IEC 17065
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Content of ISO/IEC Guide 65 to ISO/IEC
17065 (1)
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
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Content of ISO/IEC Guide 65 to ISO/IEC
17065 (2)
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Changes of revision ISO/IEC Guide 65 to
ISO/IEC 17065 (1)
The scope together with Annex B gives information on the application of the
standard for processes and services
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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)
consultancy
evaluation
scope of certification
certification body
impartiality
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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
evaluation
– determination
– review
– attestation Decision and insuance of certificate if relevant
– surveillance
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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)
Chapter 3
Chapter 4
Chapter 5
Chapter 6 (detailed)
Chapter 7 (detailed)
Chapter 8
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ISO/IEC 17065:2012
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ISO/IEC 17065:2012
4. General requirements
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ISO/IEC 17065:2012
4. General requirements
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ISO/IEC 17065:2012
4. General requirements
Clause 4.3
Liability and
financing
Clause 4.5
Confidentiality
Clause 4.6
Publicly
available
informations
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ISO/IEC 17065:2012
5. Structural requirements
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ISO/IEC 17065:2012
6. Resource requirements
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ISO/IEC 17065:2012
7. Process Requirements
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ISO/IEC 17065:2012
7. Process Requirements
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ISO/IEC 17065:2012
7. Process Requirements
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ISO/IEC 17065:2012
7. Process Requirements
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ISO/IEC 17065:2012
7. Process Requirements
Clause 7.7
Documentation
No essential changes related to ISO Guide 65 but partially
more detailed description
Clause 7.8
Directory
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ISO/IEC 17065:2012
7. Process Requirements
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ISO/IEC 17065:2012
7. Process Requirements
7.13 Complaints /
Alignment with ISO PAS 17003
Appeals
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ISO/IEC 17065:2012
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ISO/IEC 17065:2012
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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.
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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
4.1.1 4.4.1
4.1.2 4.4.2/4.4.3
4.1.4 4.4.4
4.2 a) 4.2
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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) 7.6.1
4.2 c) 5.1.3
4.2 d) 4.1.1
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
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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (4)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks
4.2 n) 5.1.4
4.2 o) 1) 4.2.6 a) – c)
4.2 o) 3) 4.2.3
4.2 p) 7.13
4.4 6.2.2
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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (5)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks
4.5 8
4.5.3 a) 8.2.1
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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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (6)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks
4.5.3 l) 7
4.5.3 l) 2) 8.3
4.5.3 m) 7.13
4.5.3 n) 8.6
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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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (7)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 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
5.2.1 6.1.2.1
5.2.2 6.1.3
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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (8)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks
5.2.3 6.1.2.2
6 7.10
7 7.13
8.1.2 4.1.2.2
9.2 7.4.1
9.3 7.4.2
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Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (9)
ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 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
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)
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 b) 4.8.1 d)
4.6 c) 4.8.1 e)
4.6 d) 4.8.1 f)
5.1.2 4.2 l)
5.1.2 4.5.3 d)
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
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
6.1.3 5.2.2
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)
7.1.3 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
7.3 9.1
7.4.1 9.2
7.4.2 9.3
7.4.3 9.4
7.4.4 10
7.4.6 11 b)/nonconformities
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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
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Cross reference ISO/IEC 17065:2012 to
ISO/IEC Guide 65:1996 (8)
ISO/IEC 17065:2012 ISO/IEC Guide 65:1996
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)
8.2/8.3 4.8.2
8.3 4.8.2
8.3 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 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)
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Back up slides
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History and Relationship
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Relation between certification body and
scheme owner
Scheme owner
Scheme
runs a scheme
Guidelines for
Stakeholder Scheme owner schemes are
given in
ISO/IEC 17067
manufactorer,
operator, Certification Body Requirements
deliverer of a and for certification
product, process or Conformity bodies are
services assessment given in ISO/IEC
17065
ISO/IEC 17030
Customer
for the labels
and their use
Scheme owner can be the certification body, governmenal authority,
trade association, group of CB‘S, …..
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Examples of resources used for
testing, inspection and auditing
Certification body
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Examples of Resources Personnel
Certification Body
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Examples: how a CB can be
positioned in a bigger organisation
Holding
Legal Entity
Div. 1.1 Reg. 1.1 Reg. 1.2 CB Div. 4.1
3.1
Business
Div. 4.3
Area . 1.1.2
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Example of possible arrangement for
Organizational Control
Certification
Body
Organizational Control is to
supervise that the related Agreement to
company does not influence follow CB rules
the person in its work for the and procedure
CB
Related Person/employee
company
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)
• Selection
…
Evaluation
• Determination
…
• Review
…
Insuance of a
• Attestation certificate after
…
decision
• Surveillance
…
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
• 7.1 General
• 7.2 Application
• 7.4 Evaluation
• 7.5 Review
• 7.9 Surveillance
• 7.12 Records
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Maintenance group (1)
Mandate
Maintain a knowledge base (e.g. the reason why a requirement has been included).
Provide expertise and be available as a panel member for the interpretation process.
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 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
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Thank you … a great work goes to
finish …
After a long and intensive work with ISO CASCO WG 29 over the last years
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 !
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