12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan

The international technical infrastructure and the

International Organization for Standardization (ISO)

12-14 November 2002, Hyatt Regency Hotel

Bishkek, Kyrgyzstan

Graeme Drake, ISO Central Secretariat, Geneva

5 topics…

Technical infrastructure modelThe model at various levels – an exampleReasons why we need itThe role of ISO in the modelStandards and conformity assessment practices

Technical infrastructure modelPolicy

Government Ministry or Department

Technical infrastructures affect: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

WTO AgreementsRegional groupings

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

International standardisation bodies (ISO, IEC,ITU,CODEX etc)

Regional bodies

Certification and claims of conformity This is the process by which a person or company claims a good or service is in compliance with a standard or technical specification 1st party2nd party3rd party After certification or a claim of conformity, at any level, marks of conformity can be issued to the product or service

Testing and inspection activities

Peer assessment and accreditation services Backup level of check.

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

Many levels to the technical infrastructure

METROLOGY(PHYSICAL STANDARDS)

SCIENTIFIC LEGAL

DOCUMENTARYSTANDARDS

CERTIFICATIONAND CLAIMS OF

CONFORMITY

PEER ASSESSMENTAND

ACCREDITATIONPOLICY

Trading Standards Service(Legal weights and measures)

MeasurementStandardsLaboratory

Certification bodies

Agreement onTechnical Barriers to Trade

APLMF

Aus

tral

ia

New

Zea

land

Reg

iona

lIn

tern

atio

nal

Regulators

Certification bodies

IQNet, IIOC

IECITU-TCODEX

http://www.iso.ch/

http://www.standards.co.nz/

The basics… why we need a technical infrastructure?

Internal reasons - Efficient and sustainable domestic economies

Economic development and poverty alleviation – technology transfer

Good regulatory practice (GRP) - OECD, APEC and the European ‘New Approach’ – from prescriptive to performance based laws

Level of government intervention and economic efficiency

Risk management

Address market failure – social, health and safety, environment

Allowing for innovation

Interoperability and interconnectivity – the knowledge economy

The basics… why we need a technical infrastructure?

External reasons - Trade – A nation’s competitive advantage

Economic efficiency through competitionInternational commitments – WTO - NotificationGlobalisation and competitive advantage

Private sector requirementsManagerial, owner (shareholder) and consumer confidenceContractual specificationsMarketing and brand differentiation

ISO and its structureISO is a international technical NGO140 countries, a mixture of government, semi-government and private bodiesEach national member body is to represent its government, industry and consumer viewsDevelops international policy and reflects this in international standards and guidesRecognition with related bodies include IEC, ITU and sector specific standardising bodiesLiaison with a number of international bodiesIts special because it produces both sector and horizontal standards and guides

ISO standardization in the model

Published

Final DIS

Draft International Standard (DIS)

Com m ittee Draft (CD)

W orking Draft (W D)

New w ork proposal (NP)Over 200 technical committees in various sectors, over 2000 subcommitees and working groupsOne 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 consensusNumber of possible publicationsISO 9001:2000 one of its biggest standardsIncreasing adoption and usage of international standards due to WTO agreements

Policy

Metrology (measurement and physical standards)

Documentary standards

Certification and claims of

conformity

• Accreditation• Peer Assessment

ISO conformity assessment in the model

Developing the technical requirements, including the publishing of a standard, is ½ the storyAfter that, mandatory or voluntary assessment of the product, system or service may be required, and sometimes a mark of conformity as wellThis has the potential to either increase or decrease costs, or enhance or retard international tradeISO/CASCO has developed international guides and standards on how to undertake this assessment function – i.e. assessment of conformity – conformity assessment

Policy

Metrology (measurement and physical standards)

Documentary standards

Certification and claims of

conformity

• Accreditation• Peer Assessment

Conformityassessment

Types of assessment of conformityDeclaration of conformity by 1st party

Suppliers declaration of conformity (SDoC)CASCO future standards 17050 and 17049

Assessment of conformity by 2nd partyProcurement chain contractsGovernment purchasing

Assessment of conformity by 3rd partyProduct certificationManagement systems certification

Mandatory or voluntary conformity assessment

Specific CASCO documents

Current document New document Group Date

1st

Party

ISO/IEC Guide 22:1996

General criteria for supplier’s declaration of conformity

ISO/IEC 17050 and 17049

WG 24

SDoC

Aug

2004

2nd Party

No specific documents

3rd Party


Methods for indicating conformity with standards for third-party certification systems

Systematic review

2003


General rules for a model third-party certification system for products

ISO/IEC

Guide 28

WG14 Apr 2005


An approach to the utilization of a supplier's quality system in third party product certification

ISO/IEC

Guide 53

Adhoc Group on Guide 53

May 2004

Specific CASCO documents (2)3rd

PartyISO/IEC Guide 65:1996

General requirements for bodies operating product certification systems


General requirements for bodies operating assessment and certification/registration of quality systems

ISO/IEC 17021

General requirements for bodies operating assessment and

certification of management systems

WG 21

Management systems

2005


General requirements for bodies operating assessment and certification/registration of environmental management systems (EMS)

ISO/IEC Guide 67

Fundamentals of product certification

WG 14

Product certification

April 2005

ISO/IEC 17024

General requirements for bodies operating

certification of persons

WG 17

Personnel certification

July 2003

Supporting processesRegardless of what type of assessment of conformity is being employed there are some fundamental process steps

Current document New document Group Date

Testing Methods of test stipulated by TCs

ISO/IEC 17025:1999

General requirements for the competence of testing and calibration laboratories

ISO/IEC 17025:1999 AMD1

General requirements for the competence of testing and

calibration laboratories

WG 25 Jun 2004

Inspection ISO/IEC 17020:1998

General criteria for the operation of various types of bodies performing inspection

Auditing ISO/IEC 19011:2002

Guidelines for quality and/or environmental management systems auditing

Accreditation and Peer AssessmentCurrent document New document Group Date

Accreditation ISO/IEC Guide 53:1993

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

ISO/IEC 17011

General requirements for bodies providing assessment

and accreditation of conformity assessment

bodies

WG 18 Feb

2004


General requirements for assessment and accreditation of certification/registration bodies

ISO/IEC TR 17010:1998

General requirements for bodies providing accreditation of inspection bodies

Peer Assessment ISO/IEC Guide 43:1997

Parts 1 and 2, Proficiency testing by interlaboratory comparisons

ISO/IEC 17040

General requirements for peer assessment of

conformity assessment bodies

WG 19 Dec 2004

Marks of conformity assessment

CASCO WG 12 is developing ISO/IEC 17030 Third party marks of conformity and their useProducts cannot carry systems related compliance marksSystematic review will take place of ISO/IEC Guide 27:1983 Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity in 2003Implications for the discussion of labelling at the WTO TBT

Mutual recognition arrangements

Management System / Product/Personnel/

laboratories and tests

CERTIFICATION BODIES

ISO/IECGuides

and Standards

ISO/IEC Guide 68 MRAs –

Dec 2002

Management System / Product/Personnel/

laboratories and tests

CERTIFICATION BODIES

DESIGNATES

ACCREDITS

CERTIFIES CERTIFIES

ACCREDITATION BODY B

ACCREDITATION BODY A

CO

NF

IDE

NC

E

CO

NF

IDE

NC

E

VOLUNTARY MUTUAL

RECOGNITION

REGULATOR G2G MUTUAL RECOGNITION

REGULATOR

ACCREDITS

DESIGNATES

Further information on conformity assessment can be found at the following link:

http://www.iso.org/

or email Graeme Drake, Head of Conformity Assessment

and Secretary of ISO/CASCO at

[email protected]

12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan

Documents

Transcript of 12-14 November 2002, Hyatt Regency Hotel Bishkek, Kyrgyzstan