CASCO Comms/58 2004-11-24

International Organization for Standardization www.iso.org

International standards and conformity assessment 1

International Standards and Conformity Assessment

by Mr. Graeme Drake, Head of Conformity Assessment ISO Central Secretariat

UNECE WP6 on Regulatory Cooperation and Standardization Policies

CASCO Comms/58 2004-11-24

Geneva, Switzerland 24 November, 2004

International standards and conformity assessment 2

The technical infrastructure

Corporate, Public and Trade Policy

Industry association, Government Ministry or Department Require technical infrastructure to:  manage risk;   be economically efficient; incorporate ‘externalities’ and protect against market failure;  ensure the public's confidence in the economy; and  participate in the free trade of goods and service UN and WTO CASCO Comms/58 2004-11-24

Metrology (measurement and physical standards) Legal metrology

(weights and measures)

Scientific measurement

(microbiological, chemical and non legal physical properties) -

Documentary standards

A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative Generally a mixture of government owned or private laboratories and research interests In some sectors government Ministries or Departments make and define documentary standards International organisations (BIPM and OIML) Regional bodies Regional bodies

Claims of conformity and certification

This is the process by which a person or company claims a good or service conforms with a standard or technical specification  1st party  2nd party  3rd party After a claim of conformity or certification, at any level, marks of conformity can be issued to the product or service Testing and inspection activities

Accreditation and peer assessment services

Further activity to ensure confidence, consistency and competence Often government or quasi-government bodies These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes) Basis for MRAs Regional bodies International standards and conformity assessment 3

Standardization in the model

Policy Metrology (measurement and physical standards) Documentary standards Claims of conformity and certification

•

Accreditation

•

Peer Assessment Over 200 technical committees in various sectors, over 2000 subcommittees and working groups One of the international standardising bodies (IEC, ITU-T, CODEX etc) Technical committees and standards development managed by individual ISO member bodies in accordance with the ISO/IEC Directives through consensus Number of possible publications New work proposal (NP) Working Draft (WD) Committee Draft (CD) Draft International Standard (DIS) ISO 9001:2000 one of its biggest standards Final DIS Increasing adoption and usage of international standards due to WTO agreements Published General adherence by national bodies to rules for standards

CASCO Comms/58 2004-11-24 International standards and conformity assessment 4

Conformity assessment

Policy Metrology (measurement and physical standards) Documentary standards Claims of conformity and certification

•

Accreditation

•

Peer Assessment

Developing technical requirements in regulations or standards is ½ the story After that, mandatory or voluntary testing, inspection and assessment of the product, system or service may be required, and sometimes this results in a lable or a mark of conformity This has the potential to affect production costs, economic efficiency, and international trade Conformity assessment ISO and IEC jointly produce international guides and standards that set the agreed requirements on how the international conformity assessment operates.

This is done through the ISO

Committee on conformity assessment

(CASCO) which has 99 countries represented CASCO Comms/58 2004-11-24 International standards and conformity assessment 5

ISO and its structure

ISO is a international technical NGO 148 countries, a mixture of government, semi-government and private bodies Each national member body is to represent its government, industry and consumer views Develops international policy and reflects this in international standards and guides Based on consensus through application of the ISO/IEC Directives Recognition with related bodies include IEC, ITU and sector specific standardising bodies Liaison with a number of international bodies

CASCO Comms/58 2004-11-24 International standards and conformity assessment 6

ISO and the WTO/TBT

Fully compliant with the

six WTO/TBT criteria

standards for international WTO TBT 3 rd Triennial Review:

Good Regulatory Practices “… minimizing the use of mandatory technical regulations and utilizing voluntary international standards opportunities” , where appropriate, could reduce the regulatory burden and open up market access “… avoidance of unnecesary obstacles to trade in the preparation, adoption and application of technical regulations (including associated standards) and conformity assessment procedures , including those related to labelling”

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ISO and the WTO/TBT Article 5

“… Sets out (for government bodies) … the use of international guides or recommendations …” and “… the importance of Members procedures …” using … and playing a full part … in the preparation by appropriate international standardizing bodies of guides and recommendations for conformity assessment “... Moreover the Committee (TBT) notes the increasing development of international standards for conformity assessment procedures ”.

CASCO Comms/58 2004-11-24 International standards and conformity assessment 8

ISO and the WTO/TBT

“ … Article 6.1.1 Accreditataion “identifies accreditation as a possible tool for Members to verify the technical competence of CA bodies”.

“When operated according to relevant international standards , … accreditation offers a mechanism which could promote confidence”.

“This could reduce trade barriers when governmental … authorities accept the results of accredited bodies”.

“Members ensuring that accreditation bodies follow … provisions on transparence and openess”.

CASCO Comms/58 2004-11-24 International standards and conformity assessment 9

ISO/CASCO

99 members of ISO are members of CASCO CASCO undertakes both policy and technical work At present it is undertaking a major revision of most of its documents, converting some of them (those specifying requirements) from guides to standards There are four areas of focus: Study and policy Technical work (the tool box) Promotion and advice Market feedback CASCO Comms/58 2004-11-24 International standards and conformity assessment 10

CASCO Comms/58 2004-11-24 Market Feedback Panel (MFP)

Study and policy

Chairman's Policy and Coordinati on Group (CPC)

CASCO

WG5 WG12 WG14 WG18 WG19 WG21 WG22 WG23 WG24 WG25 WG26 Promoti on and Support Group (CAPS) Regulat ors Interfac e Group

Promotion and support

International standards and conformity assessment 11

Principle 1 – the functional approach

Accepted by CASCO in 2002, the functional or process approach sets out the generic framework for all conformity assessment activities This forms the basis for the new international standard on conformity assessment vocabulary (17000) Need to demostrate fulfilment of specified requirements

Selection Determination

Information on selected items Information on fulfilment of specified requirements CASCO Comms/58 2004-11-24

Review and attestation

Fulfilment of specified requirements demonstrated

Yes

Surveillance needed

No END

International standards and conformity assessment 12

Principle 2 – International agreements

WTO Agreements ISO/IEC Guide 60:2004,

Code of good practice

CASCO Comms/58 2004-11-24 International standards and conformity assessment 13

Principle 3 – Common elements

Internally focused exercise to ensure international documents on conformity assessment approach the following elements in a common way for consistency: Impartiality Confidentiality and public disclosure Complaints and appeals Management systems CASCO Comms/58 2004-11-24 International standards and conformity assessment 14

General CASCO documents

ISO/IEC 17000:2004

Vocabulary and general principles and ISO/IEC Guide 2:2004

ISO/IEC Guide 60:2004

Code of good practice Common elements Impartiality (will be PAS 17001)

ISO PAS 17002:2004

Confidentiality

ISO PAS 17003:2004

Complaints and appeals Disclosure of information (will be PAS 17004) Use of management systems in conformity assessment (will be PAS 17005) CASCO Comms/58 2004-11-24 International standards and conformity assessment 15

CASCO documents for claims of conformity - general

Testing and calibration laboratories ISO/IEC FDAM 17025 – to become

ISO/IEC 17025:2005

Proficiency testing ISO/IEC Guide 43:1997 Inspection bodies ISO/IEC 17020:1998 CASCO Comms/58 2004-11-24 International standards and conformity assessment 16

CASCO documents for claims of conformity

1 st party – conformity

ISO/IEC 17050:2004

Supplier’s declaration of 3 rd party – Product certification

ISO/IEC Guide 67:2004

Fundamentals of product certification

ISO/IEC Guide 28:2004

‘System 5’

ISO/IEC Guide 53:2005

Use of the suppliers QMS in product certification ISO/IEC Guide 65:1996 for product certification bodies 3 rd party – Management systems certification (ISO/IEC Guides 62 and 66 to be replaced by

ISO/IEC 17021

) 3 rd party – Marks of conformity (ISO/IEC 17030:2003) CASCO Comms/58 2004-11-24 International standards and conformity assessment 17

ISO/IEC Guide 67:2004

Outlines 7 product certification systems that combine several of the following core elements related to product certification: Sampling Testing Evaluation Decision Licensing Surveillance CASCO Comms/58 2004-11-24 International standards and conformity assessment 18

ISO/IEC Guide 28:2004

General description of one organizational and operating approach to product certification based on system 5 in ISO/IEC Guide 67 ISO/IEC Guide 28 covers: Contracting Sampling Testing Evaluation Surveillance Certification decision CASCO Comms/58 2004-11-24 International standards and conformity assessment 19

ISO/IEC Guide 28:2004

Provides model documents Checklist for selecting product requirements Application for product certification Contract Factory inspection Conformity certificate CASCO Comms/58 2004-11-24 International standards and conformity assessment 20

CASCO documents for confidence and mutual recognition

ISO/IEC 17011:2004

Accreditation

ISO/IEC 17040:2005

Peer assessment ISO/IEC Guide 68:2002 Mutual recognition of conformity assessment results (MRAs) CASCO Comms/58 2004-11-24 International standards and conformity assessment 21

ISO/IEC 17011:2004

ISO/IEC 17011:2004,

assessment bodies Conformity assessment - General requirements for accreditation bodies accrediting conformity

Will replace: ISO/IEC Guide 58:1993,

Calibration and testing laboratory accreditation systems -- General requirements for operation and recognition

ISO/IEC Guide 61:1996,

General requirements for assessment and accreditation of certification/registration bodies

ISO/IEC TR 17010:1998,

General requirements for bodies providing accreditation of inspection bodies

CASCO Comms/58 2004-11-24 International standards and conformity assessment 22

ISO/IEC 17011 contd.

1.

Scope 2.

Normative references 3.

Terms and definitions 4.

Accreditation body 5.

Management 6.

Human resources 7.

Accreditation process 8.

Responsibilities of the accreditation body and the conformity assessment body CASCO Comms/58 2004-11-24 International standards and conformity assessment 23

ISO/IEC 17011 contd.

inclusion of ‘impartiality’ prohibition on directly undertaking other conformity assessment services or consultancy; bodies related to the accreditation body may do this but must have: different top management different people no influence distinctly different name, logos and symbols deliberate identification and management of relationships that have the potential for a conflict of interest; CASCO Comms/58 2004-11-24 International standards and conformity assessment 24

CASCO Comms/58 2004-11-24 Market Feedback Panel (MFP)

Study and policy

Chairman's Policy and Coordinati on Group (CPC)

CASCO

WG5 WG12 WG14 WG18 WG19 WG21 WG22 WG23 WG24 WG25 WG26 Promoti on and Support Group (CAPS) Regulat ors Interfac e Group

Promotion and support

International standards and conformity assessment 25

Promotion and Support

Help in writing

International Standards

so that they may be

used in conformity assessment Promote CASCO ‘tool box’

to end users Provide advice on establishment of conformity assessment systems Have a specific focus on the use of CASCO documents by regulators ISO Brochure on

Publicising your ISO 9001 and ISO 14001 certification

CASCO Comms/58 2004-11-24 International standards and conformity assessment 26

Market feedback

Gives

interpretations

on CASCO documents Undertakes

market research and surveys

find out how widely are the CACSO documents used and what people think of them to Regulators survey 2004 Triennial comprehensive survey of use and national adoption of CACSO documents Advises CASCO on new documents and timing of revisions based on market feedback CASCO Comms/58 2004-11-24 International standards and conformity assessment 27

CASCO Comms/58 2004-11-24

Thank you for your attention

Please ask questions!

Mr. Graeme Drake, ([email protected])

International standards and conformity assessment 28