PP Presentation 17065-Final1

ISO/IEC17065:2012
Conformityassessment Requirementsforbodiescertifyingproducts,
processesandservices
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

Sean MacCurtain
Page 2
2012-09-26
ISO CASCO Convenor WG 29

Christian Priller
Table of content
Importance / Impact of product certification for global trade
Product, Process and Service Certification
Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065
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
Page 3
2012-09-26
Examples - Importance and Impact of

product certification for global trade
An unknown number of sectors, regulators, schemes and CBs 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
Page 4
2012-09-26
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.
Page 5
2012-09-26
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
Page 6
2012-09-26
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
200704
1stWG29meeting definition
ofscopeandstructureofrevision
output
WD1
200709
1st DGmeeting
WD2
200804
2nd DGmeeting
WD3
200804
2nd WG29meeting
WD4
200810
3rd DGmeeting
WD5
200903
4th DGmeeting
WD6
200906
3rd WG29meeting
CD1
200907
CDoutforballot
2010-03
ChangeofConvenor Mario
Wittner>ChristianPriller
201004
4th WG29meeting
Page 7
2012-09-26
Participants
Results ballot
30
35
37
78%approval
1040comments
submitted
43

ISO/IEC 17065
date
201006
activity
output
5th DGWG29meeting
201008
CD2outforballotfortwomonths
201101
6th DGmeeting
201102
5th WG29meetinginconjunctionwithWG
32
201105
DISoutforballot
201201
7th DGmeeting(Geneva)
201202
6th WG29meeting(Munich)
201204
FDISoutforvote
201207
FDISapproved
201209
Publication
Page 8
2012-09-26
Participation
Results ballot
CD2
91%approval
570comments
submitted
DIS
35
88%approval
440comments
submitted
FDIS
30
95%approval inISO
and100% inIEC
IS

ISO/IEC 17067
Date
Activity
WG32
Participation
Output
201002
1stWG32meeting
definitionofscopeand
structureofrevision
WD0
12
201009
2ndWGmeeting
WD1
10
201102
3rd WGmeeting
WD2
15
201110
4th WGmeeting
CD
12
201111
CDoutforballot
201204
5th WGmeeting
201206
DISoutforballot
201302
6th WGmeeting
Q22013
FDISoutforballot
Q32013
ISout
Status of ISO/IEC 17067
Page 9
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 theproven
partsofGuide65
Improve where
necessary
Page 10
2012-09-26
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)
Page 11
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/PAS17001onImpartialityincludedinclause4.2
2.ISO/PAS17002onConfidentialityincludedinclause4.5
3.ISO/PAS17003onComplaintsandappealsincludedinclause7.13
4.ISO/PAS17004onDisclosureofinformationincludedinclause4.6
5.ISO/PAS17005onUseofmanagementsystemsincludedinclause8
* The PAS requirements may also be addressed in other parts of the

standards than the ones listed above
Page 12
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
Page 13
2012-09-26

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
Page 14
2012-09-26

ISO/IEC 17065 (3)
The definition chapter is considerably improved by definitions on
consultancy
evaluation
product,process,service
certificationrequirement,productrequirement
certificationscheme,certificationschemeowner
scopeofcertification
certificationbody
impartiality
Page 15
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
Page 16
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
Page 17
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 andinsuanceofcertificate ifrelevant
surveillance
The functions selection and determination are in 17065 combined as
function evaluation
Page 18
2012-09-26
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
Page 19
2012-09-26

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
Page 20
2012-09-26

ISO/IEC 17065 (9)
Detailed presentation of the most important clauses of the new
ISO/IEC17065:2012
Chapter3
Chapter4
Chapter5
Chapter6(detailed)
Chapter7(detailed)
Chapter8
Page 21
2012-09-26
ISO/IEC 17065:2012
ISO/IEC17065andrelationtoISO/IECGuide65
The definition chapter is considerably improved

by definitions based on ISO/IEC 17000
Clause 3.
Terms and
definitions
Page 22
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.Generalrequirements
No essential changes related to ISO/IEC Guide 65 but

more detailed description in:
Clause 4.1
Legal and
contractual
matters
Page 23
2012-09-26
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
Significant improvements related to ISO/IEC Guide

65:
Clause4.2
Impartiality
Page 24
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
Clause4.3
Liabilityand
financing
Clause4.4
Nondiscrimi
natoryconditions
Clause4.5
Confidentiality
Clause4.6
Publicly
available
informations
Page 25
2012-09-26
NoessentialchangesrelatedtoISO/IECGuide
65butpartiallymoredetaileddescription
ISO/IEC 17065:2012
5.Structuralrequirements
Clause5.1
Organization
Clause5.2
Safeguarding
Impartiality
Page 26
2012-09-26
No essential changes related to ISO/IEC Guide 65

but partially more detailed description
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 CBs
a committee implemented by a scheme owner
a governmental authority or an equivalent party.
ISO/IEC 17065:2012
6.Resourcerequirements
6.1Personnel
NoessentialchangesrelatedtoISO/IECGuide65but
partiallymoredetaileddescription.
6.2Evaluation
resources
SignificantchangesrelatedtoISO/IECGuide65by
introducingamoredetaileddescriptionofinternaland
externalresources.InISO/IECGuide65,externalresources
iscalledsubcontracting.Internalresourcescanalsobe
resourcesunderthedirectcontroloftheCB.
Page 27
2012-09-26
ISO/IEC 17065:2012
7.ProcessRequirements
Clause7.1
Scheme
Replacementofthetermsystembythetermscheme.
Guidanceonthedevelopmentofschemeswillbegivenin
futurebyISO/IEC17067.
Clause7.2/7.3
Application
ApplicationclauseinISO/IECGuide65(8.2)isreplacedin
ISO/IEC17065byclauses7.2applicationand7.3
applicationreviewwhichprovidesamoredetailed
information.
Page 28
2012-09-26
ISO/IEC 17065:2012
Clause7.4
Evaluation
Page 29
2012-09-26
Thefunctionsselectionanddeterminationare
combinedtothefunctionevaluation.
ApartfromthatnoessentialchangesrelatedtoISO/IEC
Guide65butpartiallymoredetaileddescription
ISO/IEC 17065:2012
Clause7.5
Review
Page 30
2012-09-26
Introducingthefunctionreviewbasedonthe
functionalapproachprovidedinISO/IEC17000.
Acertificationbodymusthaveallinformationandresults
related totheevaluation tocomplete thereview
ISO/IEC 17065:2012
NoessentialchangesrelatedtoISO/IECGuide65.
Clause7.6
Decision
Newisthepossibilitytousepersonsforthedecisionwho
areundertheorganizationalcontroloftheCB.
Thefunctiondecisionisbasedonthefoureyes
principalandcannotbeoutsourced(subcontracted).
Page 31
2012-09-26
ISO/IEC 17065:2012
Clause7.7
Documentation
Clause7.8
Directory
Page 32
2012-09-26
NoessentialchangesrelatedtoISOGuide65butpartially
moredetaileddescription
ISO/IEC 17065:2012
Clause7.9
Surveillance
NoessentialchangesrelatedtoISOGuide65butpartially
moredetaileddescription.
Clause7.10
Changes
ImprovementrelatedtoISOGuide65byintroducingamore
detaileddescriptionofchangesaffectingcertification
(introducedbytheschemeorinitiatedbytheclient).
Clause7.11
Status
ImprovementrelatedtoISOGuide65bymoredetailed
descriptionoftermination,reduction,suspensionorwithdrawal
ofcertification.
Page 33
2012-09-26
ISO/IEC 17065:2012
7.12Records
7.13Complaints/
Appeals
Page 34
2012-09-26
NoessentialchangesrelatedtoISO/IECGuide65
AlignmentwithISOPAS17003
ISO/IEC 17065:2012
Clause8.
Management
system
AlignmentwithISOPAS17005,introducingtwo
alternativeoptions.
TherequirementsforoptionAarecontainedin8.2to
8.8.
OptionBisbasedonISO9001.
Page 35
2012-09-26
ISO/IEC 17065:2012
Principles
(AnnexA)
TheinformativeAnnexAcontainstheprinciples(no
requirements)forproductcertificationbodiesandtheir
activities.
Processand
services
(AnnexB)
TheinformativeAnnexBprovidesexplanationsfor
applicationofthisstandardforcertificationofprocesses
andservices.
Page 36
2012-09-26
Cross reference ISO/IEC Guide

65:1996 to ISO/IEC 17065:2012 (1)
Toproperly compareISO/IECGuide65andISO/IEC17065andbefore going
through thecrossreference tablesthat follows,we recommend reading the
documentcontextual changesinProductcertificationsince publicationof
ISO/IECGuide65that is next tothis presentation onISOOnline.
Asnotedinthisdocument,theunderlyingconceptsofconformity
assessment,andproductcertificationinparticular,advancedsignificantly
between1996(thepublicationofISO/IECGuide65)and2009(theinitial
draftingofISO/IECDIS17065). InsomecasestherequirementfromISO/IEC
Guide65hasbeenCHANGED (notsimplyrestatedorreworded)andthe
crossreferenceisintendedtohighlightthechange
Page 37
2012-09-26
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
1.1/1st 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
7.1.1 Note 1 and 2
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
Page 38
2012-09-26
Remarks
System scheme
1 1st sen./3.4/3.5/3.6/Annex B
Supplier client

ISO/IEC 17065:2012 (3)
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)
4.2 l)
8.2.4,5.1.2
Page 39
2012-09-26
Remarks

ISO/IEC 17065:2012 (4)
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
Page 40
2012-09-26
Remarks

ISO/IEC 17065:2012 (5)
ISO/IEC 17065:2012
4.4 Note 3
7.4.5 Note
4.5
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

ISO/IEC 17065:2012 (6)
ISO/IEC 17065:2012
4.5.3 l)
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

ISO/IEC 17065:2012 (7)
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

ISO/IEC 17065:2012 (8)
ISO/IEC 17065:2012
5.2.3
6.1.2.2
7.10
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
Page 44
2012-09-26
Remarks

ISO/IEC 17065:2012 (9)
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
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
3.5
3.6
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
Page 46
2012-09-26

ISO/IEC 17065:2012
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

ISO/IEC 17065:2012
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

ISO/IEC 17065:2012
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

ISO/IEC 17065:2012
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

ISO/IEC 17065:2012
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

ISO/IEC 17065:2012
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
7.10
12.4
7.10
13.2
Page 52
2012-09-26

ISO/IEC 17065:2012
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
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

ISO/IEC 17065:2012
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
Page 54
2012-09-26
Back up slides
Thefollowing slides aremeant tocomplement the
presentation asthey give moredetails andprovide some
examples onsome oftheclausesandconceptsofthe
standard
These slides will be added toovertimetomake them more
comprehensive.Any questionsonthebackupslides can be
directed toCASCOSecretariat(charlet@iso.org)
Page 55
2012-09-26
History and Relationship
1990
1980
ISOGuide40
1983
2000
ISOGuide65
1996
ISOGuide23
1982
ISOGuide23
1982
ISOGuide67
1981
ISOGuide67
1981
Page 56
2012-09-26
2010
2012
ISO/IEC17065
ISO/IEC17067
2013
until than
existing ISO
Guide23
and 67
Relation between certification body and

scheme owner
Schemeowner
runsascheme
Scheme
Stakeholder
Scheme owner
manufactorer,
operator,
deliverer ofa
product,process or
services
CertificationBody
and
Conformity
assessment
Customer
Scheme owner can be the certification body,governmenal authority,
trade association,group of CBS,..
Page 57
2012-09-26
Guidelinesfor
schemesare
givenin
ISO/IEC17067
Requirements
forcertification
bodiesare
giveninISO/IEC
17065
ISO/IEC17030
forthelabels
andtheiruse
Examples of resources used for

testing, inspection and auditing
Certificationbody
Testing with
own ressource/
equipment
Useequipment from
Manufacturer(under
theCBcontrol)
Testreportsfrom
bodiesorparties
other than theCB
Full
outsourcing
Allthose examples arecovered inClauses6ofISO/IEC17065
Page 58
2012-09-26
Examples of Resources Personnel
CertificationBody
Own Personnel
Work Contract
FreeLancer
related Company
Contract
Allthose examples arecovered inClause6ofISO/IEC17065
Page 59
2012-09-26
Agreement
Examples: how a CB can be

positioned in a bigger organisation
Holding
LegalEntity
2
LegalEntity1
Div.1.1
Business
Area1.1.1
Reg.1.1
Reg.1.2
LegalEntity
3
LegalEntity
4
CB
LegalEntity
3.1
Div.4.1
Dep.2.1
LegalEntity
3.2
Div.4.2
Business
Area.1.1.2
ThisshowspossiblepositionofaCBwithin abigger organisation

Page 60
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
ThisrelatestoClause7.6.4ofISO/IEC17065.Thisis onepossibility for

organisational controlamong many
Page 61
2012-09-26
Functional Approach
Thefunctional approach is described inISO/IEC17000(left partofthechart below)
Selection
Evaluation
Determination
Review
Attestation
Surveillance
Insuance of a
certificate after
decision
Therightpartofthechart (evaluation Insuance ofcertificate)is theterminology

used inISO/IEC17065
Page 62
2012-09-26
Process steps / requirements

7.1
General
7.2
Application
7.3
Applicationreview
7.4
Evaluation
7.5
Review
7.6
Certificationdecision
7.7
Certificationdocumentation
7.8
Directoryofcertifiedproducts
7.9
Surveillance
7.10 Changesaffectingcertification
7.11 Termination,reduction,suspensionorwithdrawalofcertification
7.12 Records
7.13 Complaintsandappeals
Page 63
2012-09-26
Maintenance group (1)

Mandate
Maintainaknowledgebase(e.g.thereasonwhyarequirementhasbeenincluded).
AssistCASCOSecretariatwithqueriesrelatedtothestandard.
Provideexpertiseandbeavailableasapanelmemberfortheinterpretationprocess.
Adviseonanyamendmentsandcorrigendumbetweenrevisions.
Anyotherfunctiondirectlyrelatedtothecontentofthestandard.
Thelevel ofwork is expected tobe limited.Thereis nomeetingforeseen.It

is mainly required from themembers tobe available tofulfill thefunctions
described above.
Suggestionis that themembers ofthedrafting groupwould be themembers
ofthemaintenancegroup.
Page 64
2012-09-26
Maintenance group (2) Members

Mr.SumioAsada
JISC(Japan)
Ms.AndreaBarrosoMeloMonteiro deQueiroz
ABNT(Brazil)
Mr.Alister Dalrymple
AFNOR(France)
Ms.Yunhua Chen
SAC(China)
Mr.IanCleare
BSI(UnitedKingdom)
Mr.GraemeDrake
SA(Australia)
Mr.Reinaldo Figueiredo
ANSI(USA)
Mr.SteveKeeling
SA(Australia)
Mr.PedroLoste
AENOR(Spain)
Mr.LeifMadsen
DS(Denmark)
Mr.PaulMoliski
IAF
Mr.KeithMowry
ANSI(USA)
Mr.ChristianPriller(Convenor WG29)
DIN(Germany)
Mr Jaap Prummel
NEN(Netherlands)
Mr. LorenzRoggli
SNV(Switzerland) ILAC
Mr.HinrichSchaub
ON(Austria)
Mr.ThomasFacklam
IAF
Mr.Hanspeter Ischi
SNV(Switzerland) ILACalternate
Mr.Heribert Schorn
(DIN Germany)
Mr.AlanSquirrell
ILAC
Mr.PierredeRuvo
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

PP Presentation 17065-Final1

Enviado por

Dados do documento

Descrição original:

Título original

Direitos autorais

Formatos disponíveis

Compartilhar este documento

Compartilhar ou incorporar documento

Opções de compartilhamento

Você considera este documento útil?

Este conteúdo é inapropriado?

Direitos autorais:

Formatos disponíveis

PP Presentation 17065-Final1

Enviado por

Direitos autorais:

Formatos disponíveis

ISO/IEC17065:2012

Presentation on the new standard

ISO CASCO Secretary

ISO CASCO Convenor WG 29

Product, Process and Service Certification

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

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

Content of ISO/IEC Guide 65 to ISO/IEC 17065

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065

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

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

Back-up slides: examples

Examples - Importance and Impact of

Product, Process and Service Certification

Product, Process and Service

Parties that have

Timeline of Revision ISO/IEC Guide 65 to

Timeline of Revision ISO/IEC Guide 65 to

Timeline of Revision ISO/IEC Guide 67 to

Status of ISO/IEC 17067

Purpose of Revision ISO/IEC Guide 65 to

ISO IEC Guide 65

Content of ISO/IEC Guide 65 to ISO/IEC

Terms and definitions

Management system requirements

Content of ISO/IEC Guide 65 to ISO/IEC

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

Changes of revision ISO/IEC Guide 65 to

Changes of revision ISO/IEC Guide 65 to

Certification schemes are mandatory part of product certification

ISO/IEC 17065 does not contain detailed requirements on certification

Changes of revision ISO/IEC Guide 65 to

Changes of revision ISO/IEC Guide 65 to

Supplementing the impartiality requirements, a mechanism for safeguarding

Changes of revision ISO/IEC Guide 65 to

Internal and external resources shall meet the applicable requirements

Changes of revision ISO/IEC Guide 65

Decision andinsuanceofcertificate ifrelevant

Changes of revision ISO Guide 65 to

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)

Changes of revision ISO/IEC Guide 65 to

An informative Annex A contains principles for certification bodies and

Changes of revision ISO/IEC Guide 65 to

The definition chapter is considerably improved

No essential changes related to ISO/IEC Guide 65 but

legal responsibility (4.1.1)

Significant improvements related to ISO/IEC Guide

Identification of the risks to impartiality

No essential changes related to ISO/IEC Guide 65

Significant changes related to ISO/IEC Guide 65 by

Cross reference ISO/IEC Guide

Cross reference ISO/IEC Guide 65:1996 to

7.1.1 Note 1 and 2

4.1.3/1st and 2nd sentence

Cross reference ISO/IEC Guide 65:1996 to

4.2 e) 1st sentence

4.2 e) 2nd sentence

Cross reference ISO/IEC Guide 65:1996 to

4.2 o)/related bodies

4.3/1st paragraph/1st sentence

4.3/1st paragraph/2nd sentence