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ISO/IEC 17065:2012 Conformity assessment – Requirements for bodies certifying products,

processes and

services

Presentation on the new standard

2012-09-26


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Introduction

This presentation has been developed by the Drafting Group of ISO CASCO WG 29.

The aim is to support all interested parties concerned by the implementation of thisnew standard, e.g. conformity assessment bodies, accreditation bodies, industrieswith 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 certificatesunder ISO/IEC Guide 65 / ISO/IEC 17065, if you have any please send it [email protected]

ISO CASCO Secretary ISO CASCO Convenor WG 29

Sean MacCurtain Christian Priller

2012-09-26


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Table of content

• Importance / Impact of product certification for global trade 4

• Product, Process and Service Certification 5

• Timeline of Revision ISO/IEC Guide 65 to ISO/IEC 17065 7

• Purpose of Revision ISO/IEC Guide 65 to ISO/IEC 17065 10

• Content of ISO/IEC Guide 65 to ISO/IEC 17065 11

• Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 13

• ISO/IEC 17065:2012 22

• Cross reference ISO/IEC Guide 65:1996 to ISO/IEC 17065:2012 37• Cross reference ISO/IEC 17065:2012 to ISO/IEC Guide 65:1996 46

•Back-up slides: examples 55

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Examples - Importance and Impact of

product certification for global trade An unknown number of sectors, regulators, schemes and CB‘s run their operation

under this requirements with an unknown number of certificates and products,

this shows the great importance.

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Europe:New Legilation Framework (NLF) over 20

European Directives, Trade volume 1500

mrd €, about 2000 Notified Bodies

974 accredited certification bodies in Europe(source: European Co-operation Accreditation)

International levelIEC CB Scheme:

74 National Certification Bodies

382 CB Testing Laboratories

45 Satellite Laboratories

2800 Manufacturer's Testing Laboratories

70'000 CB Test Certificates issues in 2011

Asia

Japan

JIS-mark : 25 certification bodies

JAS-mark: 142 certification bodies

PSE-mark: 10 certification bodies

PSC-mark : 9 certification bodies

PAL : 13 certification bodiesChina:

35 accredited Certification Bodies

10 Certification Bodies response for China

Compulsory Certification (CCC)

50,728 companies with 280,000 certificates

for CCC

New Zealand/Australia36 certification bodies for product certification

70 product certification schemes delivered by 36

accredited bodiesBrasil70 accredited Certification Bodies

USA120 Accredited Certification Bodies

Germany:

GS-mark

91 bodies


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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 servicefulfills specified requirements.

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

established by an impartial and competent demonstration of fulfillmentof specified requirements by a third-party.

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Product, Process and Service

Certification (2)

Parties that havean interest incertification

include, but arenot limited to:

the clients of the

certificationbodies; the customersof the

organizationswhose products,

processes or

services arecertified;

governmentalauthorities;

non-governmentalorganizations;

and

consumers andother membersof the public.

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Timeline of Revision ISO/IEC Guide 65 to

ISO/IEC 17065

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date activity output Participants Results ballot

2007‐04 1st WG 29 meeting – definition

of scope and structure of revision WD1 30

2007‐09 1st DG meeting WD2

2008‐04 2nd DG meeting WD3

2008‐04 2nd WG 29 meeting WD4 35

2008‐10 3rd DG meeting WD5

2009‐03 4th DG meeting WD6

2009‐06 3rd WG 29 meeting CD1 37

2009‐07 CD out for ballot78% approval

1040 comments

submitted

2010-03 Change of Convenor Mario

Wittner > Christian Priller

2010‐04 4th WG 29 meeting 43


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ISO/IEC 17065

date activity output Participation Results ballot

2010‐06 5th DG WG 29 meeting CD2

2010‐08 CD2 out for ballot for two months91% approval

570 comments

submitted

2011‐01 6th DG meeting

2011‐02 5th WG 29 meeting in conjunction with WG

32

DIS 35

2011‐05 DIS out for ballot88% approval

440 comments

submitted

2012‐01 7th DG meeting (Geneva)

2012‐

02 6

th

WG

29

meeting

(Munich) FDIS 30

2012‐04 FDIS out for vote

2012‐07 FDIS approved 95% approval in ISO

and 100% in IEC

2012‐09 Publication IS

2012-09-26


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ISO/IEC 17067

Status of ISO/IEC 17067

Date Activity

WG 32 Output Participation Results (comments/voting)

2010‐021st WG 32 meeting –

definition of scope and

structure of revision

WD0 12

2010‐09 2nd WG meeting WD1 10

2011‐02 3rd WG meeting WD2 15

2011‐10 4th WG meeting CD 12

2011‐11 CD out for ballot 88% approval

2012‐04 5th WG meeting DIS 15

2012‐06 DIS

out

for

ballot

2013‐02 6th WG meeting FDIS

Q2 2013 FDIS out for ballot

Q3 2013 IS out

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Content of ISO/IEC Guide 65 to ISO/IEC

17065 (1)

1. Scope

2. Normative references

3. Terms and definitions

4. General requirements

5. Structural requirements

6. Resource requirements

7. Process requirements

8. Management system requirements

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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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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 ofconformity assessment: product, process and service. New are the definitionsof these three terms based on the definitions in ISO 9000 but as servicecertification is increasingly used there is a stand alone definition of “service”

The scope together with Annex B gives information on the application of thestandard 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 bodyoperating 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 certificationschemes 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 certificationschemes. Guidelines for understanding, developing, establishing, maintainingor comparing certification schemes for products, processes and services will

be provided in the future ISO/IEC 17067 “Fundamentals of product certificationand product certification schemes”

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ISO/IEC 17065 (3)

consultancy

evaluation

product, process, service

certification requirement, product requirement

certification scheme, certification scheme owner

scope of certification

certification body

impartiality

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The definition chapter is considerably improved by definitions on


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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. Theobligatory requirements of PAS 17001 are incorporated in clause 4.2. Clause 4.2clarifies in detail what activities can be performed by the certification body and anypart of the legal entity it belongs to and what activities can be performed byorganizations with which the certification body has relationships

Supplementing the impartiality requirements, a mechanism for safeguardingimpartiality is specified in clause 5.2. This mechanism is based on therecommended requirements in PAS 17001. It clarifies and details the provisions inclause 4.2 e) of ISO/IEC Guide 65 to enable the participation of partiessignificantly concerned. According to ISO/IEC17065 a possible mechanism can bea committee established by one or more certification bodies, a committeeimplemented by a scheme owner, a governmental authority or an equivalent party

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ISO/IEC 17065 (5)

The clause 6.2 on resources for evaluation is separated in internal

resources and external resources (outsourcing). According to thedefinition in clause 3.3 of ISO/IEC17065, evaluation is a combinationof selection and determination functions of a conformity assessmentactivity. Determination functions are normally testing, inspection andauditing.

Internal and external resources shall meet the applicable requirementsof the relevant International Standards and other documents as

specified by the certification scheme. The relevant InternationalStandards include for testing ISO/IEC 17025, for inspection ISO/IEC17020 and for management system auditing ISO/IEC 17021

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Changes of revision ISO/IEC Guide 65

to ISO/IEC 17065 (6) The process chapter 7 follows the functional approach provided in

ISO/IEC 17000 which consists of

– selection

– determination

– review

– attestation – surveillance

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

function “evaluation”

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evaluation

Decision and insuance

of

certificate if

relevant


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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 inISO/IEC17065 by clarifying that the review and decision has to be performed byperson(s) different from those who carried out the evaluation whereas review anddecision 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 thatsubcontracting or otherwise delegating the certification decision is not allowed. Thepossibility 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 forexample whole or majority ownership regarding the legal entity that employs orcontracts 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 establishand maintain a management system that is capable of achieving theconsistent fulfillment of the requirements of ISO/IEC 17065. Therequirements of option A are provided in detail in chapter 8. Option Bgives the possibility to use ISO 9001 as an alternative to fulfill therequirements contained in chapter 8

An informative Annex A contains principles for certification bodies andtheir certification activities which are not requirements. The listed

principles are those inspiring confidence in the certification activities. Keywords are impartiality, competence, confidentiality and openness,responsiveness to complaints and appeals and responsibility

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ISO/IEC 17065 (9)

Chapter 3

Chapter 4

Chapter 5

Chapter 6 (detailed)

Chapter

7

(detailed)

Chapter 8

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Detailed presentation of the most important clauses of the new

ISO/IEC17065:2012


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ISO/IEC 17065:2012

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Clause 3.

Terms and

definitions

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

The definition chapter is considerably improvedby definitions based on ISO/IEC 17000

• Client• Consultancy

• Evaluation

• product, process, service

• certification requirement, product requirement

• certification scheme, certification scheme owner • scope of certification

• certification body

• Impartiality


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ISO/IEC 17065:2012

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Clause 4.1

Legal and

contractual

matters


No essential changes related to ISO/IEC Guide 65 butmore detailed description in:

• legal responsibility (4.1.1)

• certification agreement and use of licenses

certificates (4.1.2)• marks of conformity (4.1.3)



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ISO/IEC 17065:2012

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Clause 4.2

Impartiality


Significant improvements related to ISO/IEC Guide65:

• Identification of the risks to impartiality

• Impartiality in relation to other parts of the same legalentity and entities under organizational control

• Impartiality in relation to separate legal entities

• Firewalls to organizations or personnel providingconsultancy



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ISO/IEC 17065:2012

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Clause 4.3

Liability and

financing


No essential changes related to ISO/IEC Guide

65 but

partially

more

detailed

description

Clause 4.4

Non‐discrimi

‐natory conditions

Clause 4.5

Confidentiality

Clause 4.6

Publicly

available

informations



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ISO/IEC 17065:2012

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Clause 5.1

Organization


No essential changes related to ISO/IEC Guide 65but partially more detailed description

Clause 5.2

SafeguardingImpartiality

5. Structural

requirements

Significant changes related to ISO/IEC Guide 65 byintroducing a mechanism for safeguarding impartialitywhich 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.


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ISO/IEC 17065:2012

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6.1 Personnel


No essential changes related to ISO/IEC Guide 65 but partially more detailed description.

6.2 Evaluation

resources

6. Resource

requirements

Significant changes related to ISO/IEC Guide 65 by introducing a more detailed description of internal and

external resources.

In

ISO/IEC

Guide

65,

external

resources

is called subcontracting. Internal resources can also be resources under the direct control of the CB.


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ISO/IEC 17065:2012

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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

7. Process

Requirements

Application clause in ISO/IEC Guide 65 (8.2) is replaced in ISO/IEC 17065 by clauses 7.2 “application” and 7.3

“application review”

which

provides

a more

detailed

information.


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ISO/IEC 17065:2012

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Clause 7.4

Evaluation


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

7. Process

Requirements


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ISO/IEC 17065:2012

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Clause 7.5

Review

7. Process

Requirements

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


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ISO/IEC 17065:2012

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Clause 7.6

Decision


No essential changes related to ISO/IEC Guide 65.

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‐eyes‐principal and can not be outsourced (subcontracted).

7. Process

Requirements


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ISO/IEC 17065:2012

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Clause 7.7

Documentation


No

essential

changes

related

to

ISO

Guide

65

but

partially

more detailed description

Clause 7.8

Directory

7. Process

Requirements


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ISO/IEC 17065:2012

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Clause 7.9

Surveillance


No essential changes related to ISO Guide 65 but partially more detailed description.

Clause 7.10

Changes

7. Process

Requirements

Clause 7.11

Status

Improvement related to ISO Guide 65 by more detailed description of termination, reduction, suspension or withdrawal of certification.

Improvement related to ISO Guide 65 by introducing a more detailed description of changes affecting certification (introduced by the scheme or initiated by the client).


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ISO/IEC 17065:2012

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7.12 Records


No essential changes related to ISO/IEC Guide 65

7.13 Complaints /

Appeals

7. Process

Requirements

Alignment with ISO PAS 17003

ISO/IEC 17065 2012


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ISO/IEC 17065:2012

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Clause 8.

Management‐

system


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.

ISO/IEC 17065 2012


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ISO/IEC 17065:2012

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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.

C f ISO/IEC G id


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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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C f ISO/IEC G id 65 1996 t


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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 Remarks1.1/1st paragraph/competent 1

1.1/1st paragraph/third-party 1 3rd sentence/3.12

1.1/1st paragraph/certificationsystem

3.9/7.1.1 System→ scheme

1.1/2nd paragraph/product,

process, service

1 1st sen./3.4/3.5/3.6/Annex B

1.2 7.1.1 Note 1 and 2

3.1 3.1 Supplier→

client

4.1.1 4.4.1

4.1.2 4.4.2/4.4.3

4.1.3/1st and 2nd sentence 7.1.2

4.1.3/3rd sentence 7.1.3

4.1.4 4.4.4

4.2 a) 4.2

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ISO/IEC 17065:2012 (3)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks4.2 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)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks4.2 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)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks4.4 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)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks

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 (8)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks

5.2.3 6.1.2.2

6 7.10

7 7.13

8.1.1 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)ISO/IEC Guide 65:1996 ISO/IEC 17065:2012 Remarks9.4 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


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ISO/IEC Guide 65:1996 (1)

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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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Cross reference ISO/IEC 17065:2012 toISO/IEC Guide 65:1996 (3)

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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


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p

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 bedirected to CASCO Secretariat ([email protected])

2012-09-26

History and Relationship


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Page 56

y p

2012-09-26

1990 2000 2010

1980

ISO Guide 40

1983

ISO

Guide

23

1982

ISO Guide 67

1981

ISO Guide 65

1996

ISO

Guide

23

1982

ISO Guide 67

1981

ISO/IEC 17065

ISO/IEC 17067

2013until than

existing ISO

Guide 23

and 67

2012

Relation between certification body and


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y

scheme owner Scheme owner

runs a scheme

Guidelines

for

schemes are

given in

ISO/IEC 17067

Requirements

for certification

bodies are

given in ISO/IEC

17065

Scheme

Stakeholder Scheme owner

manufactorer,

operator,

deliverer of

a

product,

process or

services

Certification Body

and

Conformityassessment

Customer

Scheme owner can be the certification body, governmenal authority,

trade association, group of CB‘S, …..

ISO/IEC 17030

for the labels

and their use

2012-09-26

Examples of resources used fort ti i ti d diti


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testing, inspection and auditing

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Testing with

own ressource

/ equipment

Use equipment from

Manufacturer

(underthe 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

Certification body

Examples of Resources Personnel


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Certification Body

Own Personnel

Work Contract

Free Lancer

Contract

related Company

Agreement

All those examples are

covered in

Clause

6 of

ISO/IEC

17065

Examples: how a CB can beiti d i bi i ti


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positioned in a bigger organisation

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Holding

Legal Entity 1

Div. 1.1

Business Area 1.1.1

Business Area . 1.1.2

Reg. 1.1 Reg. 1.2

Legal Entity 2

CB

Dep. 2.1

Legal Entity 3

Legal Entity 3.1

Legal Entity 3.2

Legal Entity 4

Div. 4.1

Div. 4.2

Div. 4.3

Ext.

This shows possible position of a CB within a bigger organisation

Example of possible arrangement forO i ti l C t l


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Organizational Control

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Certification

Body

Person/employeeRelatedcompany

Organizational Control is to

supervise that the related

company does not influence

the person in its work for the

CB

Agreement to

follow CB rules

and procedure

Work contract

This relates to Clause 7.6.4 of ISO/IEC 17065. This is one possibility for

organisational control among many

Functional Approach


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… • Selection

… • Determination

… • Review

… • Attestation

… • Surveillance

Evaluation

Insuance of a

certificate afterdecision

The right part of the chart (evaluation – Insuance of certificate) is the terminology

used in ISO/IEC 17065

The functional approach is described in

ISO/IEC

17000

(left part

of

the

chart below)

Process steps / requirements


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• 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

Maintenance group (1)


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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.

2012-09-26

The level of work is expected to be limited. There is no meeting foreseen. It

is mainly required from the members to be available to fulfill the functions

described above.

Suggestion is that the members of the drafting group would be the members

of the maintenance group.

Mandate

Maintenance group (2) Members


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2012-09-26

Mr. Sumio Asada JISC (Japan)

Ms. Andrea Barroso Melo Monteiro de Queiroz ABNT (Brazil)

Mr. Alister Dalrymple AFNOR (France)

Ms. Yunhua Chen SAC (China)

Mr. Ian Cleare BSI (United Kingdom)

Mr. Graeme Drake SA (Australia)

Mr.

Reinaldo Figueiredo ANSI

(USA)

Mr. Steve Keeling SA (Australia)

Mr. Pedro Loste AENOR (Spain)

Mr. Leif Madsen DS (Denmark)

Mr.

Paul

Moliski IAF

Mr.

Keith

Mowry ANSI

(USA)Mr. Christian Priller (Convenor WG 29) DIN (Germany)

Mr Jaap Prummel NEN

(Netherlands)

Mr. Lorenz Roggli SNV (Switzerland) – ILAC

Mr. Hinrich Schaub ON (Austria)

Mr. Thomas Facklam IAF

Mr. Hanspeter Ischi SNV (Switzerland) – ILAC alternate

Mr. Heribert Schorn (DIN – Germany)

Mr. Alan Squirrell ILAC

Mr. Pierre de Ruvo IEC

Thank you … a great work goes tofinish


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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 systemand all participants in the system.

And hope to see you all soon, it was a pleasure for me to work so close with you !

I wish you all good luck, health and success

Yours Christian Priller, Convenor

2012-09-26

PP+presentation+17065-final1

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