iso

1 International standards and conformity assessmentCASCO Comms/582004-11-24

www.iso.orgwww.iso.org

International Organization International Organization for Standardizationfor Standardization


International Standards andInternational Standards and

Conformity AssessmentConformity Assessment

by Mr. Graeme Drake, Head of Conformity Assessmentby Mr. Graeme Drake, Head of Conformity Assessment

ISO Central SecretariatISO Central Secretariat

UNECE WP6 onUNECE WP6 onRegulatory Cooperation and Standardization Policies Regulatory Cooperation and Standardization Policies

Geneva, SwitzerlandGeneva, Switzerland24 November, 200424 November, 2004


The technical infrastructureThe 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; andparticipate in the free trade of goods and service

UN and WTO

Metrology (measurement and physical standards) Legal metrology(weights and measures) Scientific measurement (microbiological, chemical and non legal physical properties) -

Generally a mixture of government owned or private laboratories and research interests International organisations (BIPM and OIML)

Regional bodies

Documentary standards A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative In some sectors government Ministries or Departments make and define documentary standards

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 party2nd party3rd 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


Standardization in the modelStandardization in the model

Published

Final DIS

Draft International Standard (DIS)

Committee Draft (CD)

Working Draft (WD)

New work proposal (NP)

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

ISO 9001:2000 one of its biggest standards

Increasing adoption and usage of international standards due to WTO agreements

General adherence by national bodies to rules for standards

PolicyMetrology

(measurement and physical standards)

Documentary standards

Claims of conformity and

certification

• Accreditation• Peer Assessment


Conformity assessmentConformity 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

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

Policy

Metrology (measurement and physical standards)

Documentary standards

Claims of conformity and

certification

• Accreditation• Peer Assessment

Conformityassessment


ISO and its structureISO 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


ISO and the WTO/TBTISO and the WTO/TBT

Fully compliant with the six WTO/TBT criteria for international standards

WTO TBT 3rd Triennial Review:

Good Regulatory PracticesGood Regulatory Practices

“… minimizing the use of mandatory technical regulations and utilizing voluntary international standards, where appropriate, could reduce the regulatory burden and open up market access opportunities”

“… 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”



Article 5

“… Sets out (for government bodies) … the use of international guides or recommendations …” and

“… the importance of Members using … and playing a full part … in the preparation by appropriate international standardizing bodies of guides and recommendations for conformity assessment procedures …”

“... Moreover the Committee (TBT) notes the increasing development of international standards for conformity assessment procedures”.



“ … “ … Article 6.1.1Article 6.1.1 Accreditataion 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”.


ISO/CASCOISO/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


Pro

cess and

structu

reP

rocess an

d stru

cture

Market Feedback

Panel(MFP)

Promotion and Support Group

(CAPS)

CASCO

WG5

WG12

WG14

WG18

WG19

WG21

WG22

WG23

WG24

WG25

WG26

Chairman's Policy and Coordinatio

n Group (CPC)

Regulators

Interface Group

Technical work

Use and feedback

Study and policy

Promotion and support


Principle 1 – the functional approachPrinciple 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

SelectionInformation on selected items

DeterminationInformation on

fulfilment of specified requirements

Review and attestation

Fulfilment of specified requirements demonstrated

Surveillance needed

Yes

No

END


Principle 2 – International agreementsPrinciple 2 – International agreements

WTO Agreements

ISO/IEC Guide 60:2004, Code of good practice


Principle 3 – Common elementsPrinciple 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


General CASCO documentsGeneral 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 documentsCASCO documentsfor claims of conformity - generalfor 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 documentsCASCO documentsfor claims of conformityfor claims of conformity

1st party – ISO/IEC 17050:2004 Supplier’s declaration of conformity

3rd 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

3rd party – Management systems certification (ISO/IEC Guides 62 and 66 to be replaced by ISO/IEC 17021)

3rd party – Marks of conformity (ISO/IEC 17030:2003)


ISO/IEC Guide 67:2004ISO/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



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



Provides model documents

Checklist for selecting product requirements

Application for product certification

Contract

Factory inspection

Conformity certificate


CASCO documents for confidence and CASCO documents for confidence and mutual recognitionmutual recognition

ISO/IEC 17011:2004 Accreditation

ISO/IEC 17040:2005 Peer assessment

ISO/IEC Guide 68:2002 Mutual recognition of conformity assessment results (MRAs)


ISO/IEC 17011:2004ISO/IEC 17011:2004

ISO/IEC 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies

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


ISO/IEC 17011 contd.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


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;

ISO/IEC 17011 contd.ISO/IEC 17011 contd.


Pro

cess and

structu

reP

rocess an

d stru

cture

Market Feedback

Panel(MFP)

Promotion and Support Group

(CAPS)

CASCO

WG5

WG12

WG14

WG18

WG19

WG21

WG22

WG23

WG24

WG25

WG26

Chairman's Policy and Coordinatio

n Group (CPC)

Regulators

Interface Group

Technical work

Use and feedback

Study and policy

Promotion and support


Promotion and SupportPromotion 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


Market feedbackMarket feedback

Gives interpretations on CASCO documents

Undertakes market research and surveys to find out how widely are the CACSO documents used and what people think of them

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


Thank you for your attention

Please ask questions!

Mr. Graeme Drake, ([email protected])

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