Iso Iec 17065 Acreditacion

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 ISO CASCO Convenor WG 29

Sean MacCurtain Christian Priller
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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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2012-09-26
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
Page 4 120 Accredited Certification Bodies
2012-09-26
Product, Process and Service Certification
(1)
The overall aim of certifying products, processes or services is to give

confidence to all interested parties that a product, process or service
fulfills specified requirements.
The value of certification is the degree of confidence and trust that is

established by an impartial and competent demonstration of fulfillment
of specified requirements by a third-party.
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Product, Process and Service
Certification (2)
the clients of the

certification
bodies; the customers
of the
consumers and organizations
other members whose products,
of the public. processes or
services are
Parties that have certified;
an interest in
certification
include, but are
not limited to:
non-
governmental governmental
organizations; authorities;
and
Page 6
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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
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
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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2012-09-26
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
2011-01 6th DG meeting

5th WG 29 meeting in conjunction with WG 35
2011-02 DIS
32
88% approval
2011-05 DIS out for ballot 440 comments
submitted
2012-01 7th DG meeting (Geneva)
2012-02 6th WG 29 meeting (Munich) FDIS 30
2012-04 FDIS out for vote
95% approval in ISO

2012-07 FDIS approved
and 100% in IEC
2012-09 Publication IS
Page 8
2012-09-26
ISO/IEC 17067
Date Activity WG 32 Output Participation Results (comments/voting)
1st WG 32 meeting –
Status of ISO/IEC 17067
2010-02 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
Page 9
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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)
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)
 The obligatory requirements of the ISO/PAS are included in

ISO/IEC17065
1. ISO/PAS 17001 on Impartiality included in clause 4.2
2. ISO/PAS 17002 on Confidentiality included in clause 4.5
3. ISO/PAS 17003 on Complaints and appeals included in clause 7.13
4. ISO/PAS 17004 on Disclosure of information included in clause 4.6
5. ISO/PAS 17005 on Use of management systems included in clause 8
* The PAS requirements may also be addressed in other parts of the

standards than the ones listed above
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2012-09-26
Changes of revision ISO/IEC Guide 65 to
ISO/IEC 17065 (1)
The scope in ISO/IEC17065 specifies as in ISO/IEC Guide 65 three objects of

conformity assessment: product, process and service. New are the definitions
of these three terms based on the definitions in ISO 9000 but as service
certification is increasingly used there is a stand alone definition of “service”
The scope together with Annex B gives information on the application of the
standard for processes and services
The scope clarifies that certification of products, processes and services is a

third-party activity. The scope is to be read in connection with the definition of
“certification body” in clause 3.12: third-party conformity assessment body
operating certification schemes
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ISO/IEC 17065 (2)
Certification schemes are mandatory part of product certification

(ISO/IEC17065). The requirement to operate one or more certification
schemes is contained in clause 7.1.1. The term “scheme” replaces the term
“system” used in ISO/IEC Guide 65
ISO/IEC 17065 does not contain detailed requirements on certification

schemes. Guidelines for understanding, developing, establishing, maintaining
or comparing certification schemes for products, processes and services will
be provided in the future ISO/IEC 17067 “Fundamentals of product certification
and product certification schemes”
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ISO/IEC 17065 (3)
 The definition chapter is considerably improved by definitions on
consultancy
evaluation
product, process, service
certification requirement, product requirement
certification scheme, certification scheme owner
scope of certification
certification body
impartiality
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2012-09-26
ISO/IEC 17065 (4)
The requirements on impartiality in clause 4.2 have significantly been improved

compared with the requirements in clause 4.2 o) of ISO/IEC Guide 65. The
obligatory requirements of PAS 17001 are incorporated in clause 4.2. Clause 4.2
clarifies in detail what activities can be performed by the certification body and any
part of the legal entity it belongs to and what activities can be performed by
organizations with which the certification body has relationships
Supplementing the impartiality requirements, a mechanism for safeguarding

impartiality is specified in clause 5.2. This mechanism is based on the
recommended requirements in PAS 17001. It clarifies and details the provisions in
clause 4.2 e) of ISO/IEC Guide 65 to enable the participation of parties
significantly concerned. According to ISO/IEC17065 a possible mechanism can be
a committee established by one or more certification bodies, a committee
implemented by a scheme owner, a governmental authority or an equivalent party
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2012-09-26
ISO/IEC 17065 (5)
The clause 6.2 on resources for evaluation is separated in internal

resources and external resources (outsourcing). According to the
definition in clause 3.3 of ISO/IEC17065, evaluation is a combination
of selection and determination functions of a conformity assessment
activity. Determination functions are normally testing, inspection and
auditing.
Internal and external resources shall meet the applicable requirements

of the relevant International Standards and other documents as
specified by the certification scheme. The relevant International
Standards include for testing ISO/IEC 17025, for inspection ISO/IEC
17020 and for management system auditing ISO/IEC 17021
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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
evaluation
– determination
– 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)
The four-eyes principle contained in clause 4.2 f of ISO Guide 65 is kept in

ISO/IEC17065 by clarifying that the review and decision has to be performed by
person(s) different from those who carried out the evaluation whereas review and
decision can be done by the same person(s)
As in ISO/IEC Guide 65 the certification decision shall be made by person(s)

employed by or under contract with the certification body meaning that
subcontracting or otherwise delegating the certification decision is not allowed. The
possibility to use person(s) for the decision who are under the organizational
control (clause 7.6.4) of the certification body is new. Organizational control is for
example whole or majority ownership regarding the legal entity that employs or
contracts the person(s) who make the certification decision
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ISO/IEC 17065 (8)
The management system requirements are concentrated in chapter 8.

According to PAS 17005 the certification body has two options to establish
and maintain a management system that is capable of achieving the
consistent fulfillment of the requirements of ISO/IEC 17065. The
requirements of option A are provided in detail in chapter 8. Option B
gives the possibility to use ISO 9001 as an alternative to fulfill the
requirements contained in chapter 8
An informative Annex A contains principles for certification bodies and

their certification activities which are not requirements. The listed
principles are those inspiring confidence in the certification activities. Key
words are impartiality, competence, confidentiality and openness,
responsiveness to complaints and appeals and responsibility
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ISO/IEC 17065 (9)
 Detailed presentation of the most important clauses of the new

ISO/IEC17065:2012
Chapter 3
Chapter 4
Chapter 5
Chapter 6 (detailed)
Chapter 7 (detailed)
Chapter 8
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ISO/IEC 17065:2012
ISO/IEC 17065 and relation to ISO/IEC Guide 65
The definition chapter is considerably improved

by definitions based on ISO/IEC 17000
• Client
• Consultancy
Clause 3. • Evaluation
Terms and • product, process, service
definitions • certification requirement, product requirement
• certification scheme, certification scheme owner
• scope of certification
• certification body
• Impartiality
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ISO/IEC 17065:2012
No essential changes related to ISO/IEC Guide 65 but

more detailed description in:
Clause 4.1
Legal and • legal responsibility (4.1.1)
contractual • certification agreement and use of licenses
matters certificates (4.1.2)
• marks of conformity (4.1.3)
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ISO/IEC 17065:2012
Significant improvements related to ISO/IEC Guide

65:
• Identification of the risks to impartiality

Clause 4.2 • Impartiality in relation to other parts of the same legal
Impartiality entity and entities under organizational control
• Impartiality in relation to separate legal entities
• Firewalls to organizations or personnel providing
consultancy
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ISO/IEC 17065:2012
Clause 4.3
Liability and
financing
Clause 4.4 No essential changes related to ISO/IEC Guide

Non-discrimi- 65 but partially more detailed description
natory conditions
Clause 4.5
Confidentiality
Clause 4.6
Publicly
available
informations
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ISO/IEC 17065:2012
5. Structural requirements
Clause 5.1 No essential changes related to ISO/IEC Guide 65

Organization but partially more detailed description
Significant changes related to ISO/IEC Guide 65 by

introducing a mechanism for safeguarding impartiality
Clause 5.2 which can be
Safeguarding a committee established by one or more CB’s
Impartiality
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
No essential changes related to ISO/IEC Guide 65 but

6.1 Personnel
partially more detailed description.
Significant changes related to ISO/IEC Guide 65 by

6.2 Evaluation introducing a more detailed description of internal and
resources 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
Replacement of the term “system” by the term “scheme”.

Clause 7.1 Guidance on the development of schemes will be given in
Scheme future by ISO/IEC 17067.
Application clause in ISO/IEC Guide 65 (8.2) is replaced in

Clause 7.2/7.3 ISO/IEC 17065 by clauses 7.2 “application” and 7.3
Application “application review” which provides a more detailed
information.
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ISO/IEC 17065:2012
The functions “selection” and “determination” are

Clause 7.4 combined to the function “evaluation”.
Evaluation Apart from that no essential changes related to ISO/IEC
Guide 65 but partially more detailed description
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ISO/IEC 17065:2012
Introducing the function „review“ based on the

Clause 7.5 functional approach provided in ISO/IEC 17000.
Review A certification body must have all information and results
related to the evaluation to complete the review
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2012-09-26
ISO/IEC 17065:2012
No essential changes related to ISO/IEC Guide 65.

Clause 7.6
New is the possibility to use persons for the decision who
Decision
are under the organizational control of the CB.
The function “decision” is based on the four-eyes-
principal and can not be outsourced (subcontracted).
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ISO/IEC 17065:2012
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
No essential changes related to ISO Guide 65 but partially

Clause 7.9
more detailed description.
Surveillance
Improvement related to ISO Guide 65 by introducing a more

Clause 7.10
detailed description of changes affecting certification
Changes (introduced by the scheme or initiated by the client).
Clause 7.11 Improvement related to ISO Guide 65 by more detailed

Status description of termination, reduction, suspension or withdrawal
of certification.
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ISO/IEC 17065:2012
7.12 Records No essential changes related to ISO/IEC Guide 65
7.13 Complaints /
Alignment with ISO PAS 17003
Appeals
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ISO/IEC 17065:2012
Clause 8. Alignment with ISO PAS 17005, introducing two

Management- alternative options.
system
The requirements for option A are contained in 8.2 to
8.8.
Option B is based on ISO 9001.
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ISO/IEC 17065:2012
The informative Annex A contains the principles (no

Principles requirements) for product certification bodies and their
(Annex A) activities.
Process and The informative Annex B provides explanations for

services application of this standard for certification of processes
(Annex B) and services.
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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.
As noted in this document, the underlying concepts of conformity

assessment, and product certification in particular, advanced significantly
between 1996 (the publication of ISO/IEC Guide 65) and 2009 (the initial
drafting of ISO/IEC DIS 17065). In some cases the requirement from ISO/IEC
Guide 65 has been CHANGED (not simply restated or reworded) and the
cross reference is intended to highlight the change
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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 3.9/7.1.1 System → scheme

system
1.1/2nd paragraph/product, 1 1st sen./3.4/3.5/3.6/Annex B
process, service
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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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
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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
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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)
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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)
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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
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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
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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)
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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
3.9/7.1.1 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 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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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)
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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
The following slides are meant to complement the

presentation as they give more details and provide some
examples on some of the clauses and concepts of the
standard
These slides will be added to over time to make them more

comprehensive. Any questions on the back up slides can be
directed to CASCO Secretariat (charlet@iso.org)
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History and Relationship
1980 1990 2000 2010 2012
ISO Guide 40 ISO Guide 65 ISO/IEC 17065

1983 1996
ISO/IEC 17067
ISO Guide 23 ISO Guide 23 2013
1982 1982 until than
existing ISO
ISO Guide 67 ISO Guide 67 Guide 23
1981 1981 and 67
Page 56
2012-09-26
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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2012-09-26
Examples of resources used for
testing, inspection and auditing
Certification body
Testing with Use equipment from Test reports from

own ressource / Manufacturer (under bodies or parties Full
equipment the CB control) other than the CB outsourcing
All those examples are covered in Clauses 6 of ISO/IEC 17065
Page 58
2012-09-26
Examples of Resources Personnel
Certification Body
Own Personnel Free Lancer related Company
Work Contract Contract Agreement
All those examples are covered in Clause 6 of ISO/IEC 17065
Page 59
2012-09-26
Examples: how a CB can be
positioned in a bigger organisation
Holding
Legal Entity Legal Entity Legal Entity

Legal Entity 1 Ext.
2 3 4
Legal Entity
Div. 1.1 Reg. 1.1 Reg. 1.2 CB Div. 4.1
3.1
Business Legal Entity

Dep. 2.1 Div. 4.2
Area 1.1.1 3.2
Business
Div. 4.3
Area . 1.1.2
This shows possible position of a CB within a bigger organisation
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2012-09-26
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
Page 61
2012-09-26
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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2012-09-26
Process steps / requirements
• 7.1 General
• 7.2 Application
• 7.3 Application review
• 7.4 Evaluation
• 7.5 Review
• 7.6 Certification decision
• 7.7 Certification documentation
• 7.8 Directory of certified products
• 7.9 Surveillance
• 7.10 Changes affecting certification
• 7.11 Termination, reduction, suspension or withdrawal of certification
• 7.12 Records
• 7.13 Complaints and appeals
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Maintenance group (1)
Mandate
Maintain a knowledge base (e.g. the reason why a requirement has been included).
Assist CASCO Secretariat with queries related to the standard.
Provide expertise and be available as a panel member for the interpretation process.
Advise on any amendments and corrigendum between revisions.
Any other function directly related to the content of the standard.
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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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

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ISO/IEC 17065:2012

Conformity assessment – Requirements for bodies certifying products,

Presentation on the new standard

We welcome any information about product certification in your region, country, e. g.

ISO CASCO Secretary ISO CASCO Convenor WG 29

The overall aim of certifying products, processes or services is to give

The value of certification is the degree of confidence and trust that is

the clients of the

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

2011-01 6th DG meeting

2012-01 7th DG meeting (Geneva)

2012-02 6th WG 29 meeting (Munich) FDIS 30

2012-04 FDIS out for vote

95% approval in ISO

Date Activity WG 32 Output Participation Results (comments/voting)

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

ISO IEC Guide 65 ISO IEC 17065

Maintain the proven

 The content is aligned with the new structural requirements decided by

 The obligatory requirements of the ISO/PAS are included in

1. ISO/PAS 17001 on Impartiality included in clause 4.2

2. ISO/PAS 17002 on Confidentiality included in clause 4.5

3. ISO/PAS 17003 on Complaints and appeals included in clause 7.13

4. ISO/PAS 17004 on Disclosure of information included in clause 4.6

5. ISO/PAS 17005 on Use of management systems included in clause 8

* The PAS requirements may also be addressed in other parts of the

The scope in ISO/IEC17065 specifies as in ISO/IEC Guide 65 three objects of

The scope clarifies that certification of products, processes and services is a

Certification schemes are mandatory part of product certification

ISO/IEC 17065 does not contain detailed requirements on certification

 The definition chapter is considerably improved by definitions on

product, process, service

certification requirement, product requirement

certification scheme, certification scheme owner

The requirements on impartiality in clause 4.2 have significantly been improved

Supplementing the impartiality requirements, a mechanism for safeguarding

The clause 6.2 on resources for evaluation is separated in internal

Internal and external resources shall meet the applicable requirements

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

The four-eyes principle contained in clause 4.2 f of ISO Guide 65 is kept in

As in ISO/IEC Guide 65 the certification decision shall be made by person(s)

The management system requirements are concentrated in chapter 8.

An informative Annex A contains principles for certification bodies and

 Detailed presentation of the most important clauses of the new

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

The definition chapter is considerably improved

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

No essential changes related to ISO/IEC Guide 65 but

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

Significant improvements related to ISO/IEC Guide

• Identification of the risks to impartiality

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