Ppt presentation 17065

Page 1
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
charlet@iso.org
ISO CASCO Secretary ISO CASCO Convenor WG 29
Sean 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
2012-09-26

Examples - Importance and Impact
of product certification for global
tradeAn 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.
2012-09-26
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 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
New Zealand/Australia
36 certification bodies for product certification
70 product certification schemes delivered by 36
accredited bodiesBrasil
70 accredited Certification Bodies
USA
120 Accredited Certification Bodies
Germany:
GS-mark
91 bodies

Product, Process and Service
Certification (1)
2012-09-26

Product, Process and Service
Certification (2)
2012-09-26

Timeline of Revision ISO/IEC Guide 65
to ISO/IEC 17065
2012-09-26
date activity output Participants Results ballot
2007-04
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% approval
1040 comments
submitted
2010-03
Change of Convenor Mario
Wittner > Christian Priller
2010-04 4th
WG 29 meeting 43

to ISO/IEC 17065
date activity output Participation Results ballot
2010-06 5th
DG WG 29 meeting CD2
2010-08 CD2 out for ballot for two months
91% approval
570 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% approval
440 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
2012-09-26

to ISO/IEC 17067
Status of ISO/IEC 17067
Date Activity WG 32 Output Participation Results (comments/voting)
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 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
2012-09-26

Purpose of Revision ISO/IEC Guide 65
to ISO/IEC 17065
2012-09-26
Maintain the proven
parts of Guide 65
Improve where
necessary
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)
2012-09-26
 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)
2012-09-26
 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)
2012-09-26

2012-09-26

2012-09-26
 The definition chapter is considerably improved by definitions on

2012-09-26

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”
2012-09-26
evaluation
Decision and insuance of certificate if relevant

Changes of revision ISO Guide 65 to
ISO/IEC 17065 (7)
2012-09-26

2012-09-26

2012-09-26
 Detailed presentation of the most important clauses of the new
ISO/IEC17065:2012

ISO/IEC 17065:2012
2012-09-26
Clause 3.
Terms and
definitions
ISO/IEC 17065 and relation to ISO/IEC Guide 65

ISO/IEC 17065:2012
2012-09-26
Clause 4.1
Legal and
contractual
matters
4. General requirements

ISO/IEC 17065:2012
2012-09-26
Clause 4.2
Impartiality

ISO/IEC 17065:2012
2012-09-26
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
2012-09-26
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 be
a committee established by one or more CB’s
a committee implemented by a scheme owner
a governmental authority or an equivalent party.

ISO/IEC 17065:2012
2012-09-26
6.1 Personnel
6.2 Evaluation
resources
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
2012-09-26
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
2012-09-26
Clause 7.4
Evaluation

ISO/IEC 17065:2012
2012-09-26
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
2012-09-26
Clause 7.6
Decision

ISO/IEC 17065:2012
2012-09-26
Clause 7.7
Documentation
Clause 7.8
Directory

ISO/IEC 17065:2012
2012-09-26
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
2012-09-26
7.12 Records
7.13 Complaints /
Appeals
Alignment with ISO PAS 17003

ISO/IEC 17065:2012
2012-09-26
Clause 8.
Management-
system

ISO/IEC 17065:2012
2012-09-26
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)
2012-09-26

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
2012-09-26

65:1996 to ISO/IEC 17065:2012 (3)
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
2012-09-26

65:1996 to ISO/IEC 17065:2012 (4)
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
2012-09-26

65:1996 to ISO/IEC 17065:2012 (5)
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)
2012-09-26

65:1996 to ISO/IEC 17065:2012 (6)
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)
2012-09-26

65:1996 to ISO/IEC 17065:2012 (7)
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
2012-09-26

65:1996 to ISO/IEC 17065:2012 (8)
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
2012-09-26

65:1996 to ISO/IEC 17065:2012 (9)
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)
2012-09-26

Cross reference ISO/IEC 17065:2012
to ISO/IEC Guide 65:1996 (1)
2012-09-26
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
3.5 1.1/2nd
3.6 1.1/2nd
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

2012-09-26
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

2012-09-26
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)

2012-09-26
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

2012-09-26
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

2012-09-26
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

2012-09-26
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

2012-09-26
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
2012-09-26

Back up slides
2012-09-26

History and Relationship
2012-09-26
1990 2000 20101980
ISO Guide 40
1983
ISO Guide 23
1982
ISO Guide 67
1981
ISO Guide 65
1996
ISO Guide 23
1982
ISO Guide 67
1981
ISO/IEC 17065
ISO/IEC 17067
2013
until than
existing ISO
Guide 23
and 67
2012

Relation between certification body
and scheme owner
Scheme owner
runs a scheme
Scheme owner
runs a scheme
Guidelines for
schemes are
given in
ISO/IEC 17067
Guidelines for
schemes are
given in
ISO/IEC 17067
Requirements
for certification
bodies are
given in ISO/IEC
17065
Requirements
for certification
bodies are
given in ISO/IEC
17065
Stakeholder
manufactorer,
operator,
deliverer of a
product, process or
services
Certification Body
and
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
ISO/IEC 17030
for the labels
and their use
2012-09-26

Examples of resources used for
testing, inspection and auditing
2012-09-26
All those examples are covered in Clauses 6 of ISO/IEC 17065
Certification body

Examples of Resources Personnel
2012-09-26
All those examples are covered in Clause 6 of ISO/IEC 17065

Examples: how a CB can be
positioned in a bigger organisation
2012-09-26
This shows possible position of a CB within a bigger organisation

Example of possible arrangement
for Organizational Control
2012-09-26
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
2012-09-26
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
2012-09-26

Maintenance group (1)
2012-09-26
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
2012-09-26
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

Ppt presentation 17065

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