ISO/IEC 17065:2012 Conformity assessment ... - ISEAL Alliance

ISO/IEC 17065:2012

Conformity assessment – Requirements for bodies certifying products, processes and services

Presentation on the new standard Page 1 2012-09-26

Introduction This presentation has been developed by the Drafting Group of ISO CASCO WG 29. The aim is to support all interested parties concerned by the implementation of this new standard, e.g. conformity assessment bodies, accreditation bodies, industries with general information and contribute to an harmonized transition. This is an open presentation without any copyrights and can be used by anyone. We welcome any information about product certification in your region, country, e. g. number of schemes, number of accredited certification bodies, number of certificates under ISO/IEC Guide 65 / ISO/IEC 17065, if you have any please send it to [email protected]

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

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 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.

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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 Page 6 2012-09-26

the customers of the organizations whose products, processes or services are certified;

governmental authorities;

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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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 Page 8 2012-09-26

Changes of revision ISO/IEC Guide 65 to ISO/IEC 17065 (1) The scope in ISO/IEC17065 specifies as in ISO/IEC Guide 65 three objects of conformity assessment: product, process and service. New are the definitions of these three terms based on the definitions in ISO 9000 but as service certification is increasingly used there is a stand alone definition of “service”

The scope together with Annex B gives information on the application of the standard for processes and services

The scope clarifies that certification of products, processes and services is a third-party activity. The scope is to be read in connection with the definition of “certification body” in clause 3.12: third-party conformity assessment body operating certification schemes

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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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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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• • • • • • • • •

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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• 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 Page 14 2012-09-26

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.

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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.

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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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Clause 7.4 Evaluation

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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


Clause 7.5 Review

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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


No essential changes related to ISO/IEC Guide 65. Clause 7.6 Decision

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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).


Clause 7.7 Documentation Clause 7.8 Directory

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


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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7.12 Records

7.13 Complaints / Appeals

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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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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 Page 26 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 ([email protected])

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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

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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, ….. Page 29 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

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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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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 Page 32 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 33 2012-09-26

Functional Approach The functional approach is described in ISO/IEC 17000 (left part of the chart below)

… … … … …

• Selection • Determination

Evaluation

• 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 Page 34 2012-09-26