ISO/IEC 17065:2012
Conformity assessment – Requirements for bodies certifying products,
processes and services
Presentation on the new standard
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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
Sean MacCurtain
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2012-09-26
ISO CASCO Convenor WG 29
Christian Priller
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.
Asia
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
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
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 bodies
Brasil
70 accredited Certification Bodies
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USA
120 Accredited Certification Bodies
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;
consumers and
other members
of the public.
Parties that have
an interest in
certification
include, but are
not limited to:
nongovernmental
organizations;
and
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the customers
of the
organizations
whose products,
processes or
services are
certified;
governmental
authorities;
Timeline of Revision ISO/IEC Guide 65 to
ISO/IEC 17065
date
activity
2007-04
1st WG 29 meeting – definition of
scope and structure of revision
WD1
2007-09
1st DG meeting
WD2
2008-04
2nd DG meeting
WD3
2008-04
2nd WG 29 meeting
WD4
2008-10
3rd DG meeting
WD5
2009-03
4th DG meeting
WD6
2009-06
3rd WG 29 meeting
CD1
2009-07
CD out for ballot
2010-03
Change of Convenor Mario
Wittner > Christian Priller
2010-04
4th WG 29 meeting
Page 7
2012-09-26
output
Participants
Results ballot
30
35
37
78% approval
1040 comments
submitted
43
Timeline of Revision ISO/IEC Guide 65 to
ISO/IEC 17065
date
2010-06
activity
output
5th DG WG 29 meeting
2010-08
CD2 out for ballot for two months
2011-01
6th DG meeting
2011-02
5th WG 29 meeting in conjunction with WG
32
2011-05
DIS out for ballot
2012-01
7th DG meeting (Geneva)
2012-02
6th WG 29 meeting (Munich)
2012-04
FDIS out for vote
2012-07
FDIS approved
2012-09
Publication
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2012-09-26
Participation
Results ballot
CD2
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
Participation
Output
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
2012-04
5th WG meeting
2012-06
DIS out for ballot
2013-02
6th WG meeting
Q2 2013
FDIS out for ballot
Q3 2013
IS out
Status of ISO/IEC 17067
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2012-09-26
Results (comments/voting)
88% approval
DIS
FDIS
15
Purpose of Revision ISO/IEC Guide 65 to
ISO/IEC 17065
ISO IEC 17065
ISO IEC Guide 65
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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2012-09-26
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
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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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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Changes of revision ISO/IEC Guide 65 to
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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Changes of revision ISO/IEC Guide 65 to
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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Changes of revision ISO/IEC Guide 65 to
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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Changes of revision ISO/IEC Guide 65 to
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
– determination
evaluation
– 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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Changes of revision ISO/IEC Guide 65 to
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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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
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
Clause 3.
Terms and
definitions
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2012-09-26
•
•
•
•
•
•
•
•
•
Client
Consultancy
Evaluation
product, process, service
certification requirement, product requirement
certification scheme, certification scheme owner
scope of certification
certification body
Impartiality
ISO/IEC 17065:2012
4. General requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
No essential changes related to ISO/IEC Guide 65 but
more detailed description in:
Clause 4.1
Legal and
contractual
matters
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• legal responsibility (4.1.1)
• certification agreement and use of licenses
certificates (4.1.2)
• marks of conformity (4.1.3)
ISO/IEC 17065:2012
4. General requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Significant improvements related to ISO/IEC Guide
65:
Clause 4.2
Impartiality
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2012-09-26
• Identification of the risks to impartiality
• Impartiality in relation to other parts of the same legal
entity and entities under organizational control
• Impartiality in relation to separate legal entities
• Firewalls to organizations or personnel providing
consultancy
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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No essential changes related to ISO/IEC Guide
65 but partially more detailed description
ISO/IEC 17065:2012
5. Structural requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 5.1
Organization
No essential changes related to ISO/IEC Guide 65
but partially more detailed description
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 CB’s
a committee implemented by a scheme owner
a governmental authority or an equivalent party.
Page 26
2012-09-26
ISO/IEC 17065:2012
6. Resource requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
6.1 Personnel
No essential changes related to ISO/IEC Guide 65 but
partially more detailed description.
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.
Page 27
2012-09-26
ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.1
Scheme
Replacement of the term “system” by the term “scheme”.
Guidance on the development of schemes will be given in
future by ISO/IEC 17067.
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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2012-09-26
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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2012-09-26
The functions “selection” and “determination” are
combined to the function “evaluation”.
Apart from that no essential changes related to ISO/IEC
Guide 65 but partially more detailed description
ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.5
Review
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2012-09-26
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
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
No essential changes related to ISO/IEC Guide 65.
Clause 7.6
Decision
New is the possibility to use persons for the decision who
are under the organizational control of the CB.
The function “decision” is based on the four-eyesprincipal and can not be outsourced (subcontracted).
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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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2012-09-26
No essential changes related to ISO Guide 65 but partially
more detailed description
ISO/IEC 17065:2012
7. Process Requirements
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 7.9
Surveillance
No essential changes related to ISO Guide 65 but partially
more detailed description.
Clause 7.10
Changes
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 7.11
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
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2012-09-26
No essential changes related to ISO/IEC Guide 65
Alignment with ISO PAS 17003
ISO/IEC 17065:2012
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Clause 8.
Managementsystem
Alignment with ISO PAS 17005, introducing two
alternative options.
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
ISO/IEC 17065 and relation to ISO/IEC Guide 65
Principles
(Annex A)
The informative Annex A contains the principles (no
requirements) for product certification bodies and their
activities.
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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2012-09-26
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
1.1/1st paragraph/competent
1
1.1/1st paragraph/third-party
1 3rd sentence/3.12
1.1/1st paragraph/certification
system
1.1/2nd paragraph/product,
process, service
1.2
3.9/7.1.1
3.1
3.1
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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Remarks
System → scheme
1 1st sen./3.4/3.5/3.6/Annex B
7.1.1 Note 1 and 2
Supplier → client
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (3)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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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2012-09-26
Remarks
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (4)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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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2012-09-26
Remarks
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (5)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
4.5.3 d)
5.1.2
4.5.3 e)
5.1.2
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)
Page 41
2012-09-26
Remarks
ISO/IEC17065 requirement
applies only to individuals in the
certification process
ISO/IEC17065 requirement
more focused
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (6)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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)
Page 42
2012-09-26
Remarks
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (7)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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
Page 43
2012-09-26
Remarks
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (8)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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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2012-09-26
Remarks
Cross reference ISO/IEC Guide 65:1996 to
ISO/IEC 17065:2012 (9)
ISO/IEC Guide 65:1996
ISO/IEC 17065:2012
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)
Page 45
2012-09-26
Remarks
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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2012-09-26
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
Page 47
2012-09-26
Cross reference ISO/IEC 17065:2012 to
ISO/IEC Guide 65:1996 (3)
ISO/IEC 17065:2012
ISO/IEC Guide 65:1996
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)
Page 48
2012-09-26
Cross reference ISO/IEC 17065:2012 to
ISO/IEC Guide 65:1996 (4)
ISO/IEC 17065:2012
ISO/IEC Guide 65:1996
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
6.1.2.2
4.5.3 c) 17065 requirement applies only to
individuals in the certification process
5.2.3
6.1.3
5.2.2
6.2.1
4.3/2nd paragraph
6.2.2
4.4
Page 49
2012-09-26
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)
7.1.1
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
Page 50
2012-09-26
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
7.2 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
Page 51
2012-09-26
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
Page 52
2012-09-26
Cross reference ISO/IEC 17065:2012 to
ISO/IEC Guide 65:1996 (8)
ISO/IEC 17065:2012
ISO/IEC Guide 65:1996
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)
Page 53
2012-09-26
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)
Annex B
1.1/2nd paragraph/product, process, service
Page 54
2012-09-26
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)
Page 55
2012-09-26
History and Relationship
1990
1980
ISO Guide 40
1983
2000
ISO Guide 65
1996
ISO Guide 23
1982
ISO Guide 23
1982
ISO Guide 67
1981
ISO Guide 67
1981
Page 56
2012-09-26
2010
2012
ISO/IEC 17065
ISO/IEC 17067
2013
until than
existing ISO
Guide 23
and 67
Relation between certification body and
scheme owner
Scheme owner
runs a scheme
Scheme
Stakeholder
Guidelines for
schemes are
given in
ISO/IEC 17067
Scheme owner
manufactorer,
operator,
Certification Body
deliverer of a
and
product, process or
services
Conformity
assessment
Customer
Scheme owner can be the certification body, governmenal authority,
trade association, group of CB‘S, …..
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2012-09-26
Requirements
for certification
bodies are
given in ISO/IEC
17065
ISO/IEC 17030
for the labels
and their use
Examples of resources used for
testing, inspection and auditing
Certification body
Testing with
own ressource /
equipment
Use equipment from
Manufacturer (under
the CB control)
Test reports from
bodies or parties
other than the CB
Full
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
Work Contract
Free Lancer
related Company
Contract
All those examples are covered in Clause 6 of ISO/IEC 17065
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2012-09-26
Agreement
Examples: how a CB can be
positioned in a bigger organisation
Holding
Legal Entity
2
Legal Entity 1
Div. 1.1
Business
Area 1.1.1
Reg. 1.1
Reg. 1.2
Legal Entity
3
Legal Entity
4
CB
Legal Entity
3.1
Div. 4.1
Dep. 2.1
Legal Entity
3.2
Div. 4.2
Business
Area . 1.1.2
This shows possible position of a CB within a bigger organisation
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2012-09-26
Div. 4.3
Ext.
Example of possible arrangement for
Organizational Control
Certification
Body
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
Related
company
Person/employee
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
• Attestation
• Surveillance
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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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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2012-09-26
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