1 Having confidence in certificationCASCO Comms/0602004-12-07

www.iso.orgwww.iso.org

International Organization International Organization for Standardizationfor Standardization

2 Having confidence in certificationCASCO Comms/0602004-12-07

Having confidence in certification

by Mr. Graeme Drakeby Mr. Graeme DrakeHead of Conformity AssessmentHead of Conformity Assessment

ISO Central SecretariatISO Central Secretariat

ISO CASCO/DEVCO – BISRegional workshop on CertificationNew Delhi, India, 7 December 2004

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Outline

Added confidence in the technical infrastructure

Accreditation

Peer assessment

ISO position

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Added confidence in thetechnical 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

WTO Agreements

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

Peer assessment and accreditation 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

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Accreditation

is a third-party assessment and decision that a conformity assessment body formally demonstrates its competence to carry out specific conformity assessment tasks

accreditation bodies are authorative, having broad industry and government backing

There is one new International Standard for accreditation – ISO/IEC 17011:2004

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ISO/IEC 17011:2004

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

Has replaced:

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

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Accreditation

ISO supports accreditation that:

takes place in accordance with ISO/IEC 17011:2004; and

applies the relevant ISO/IEC Standards and Guides for the activities being accredited (ISO/IEC Guide 65 for product certification bodies , ISO/IEC Guides 62 and 66 for management system certification bodies (to become ISO/IEC 17021), ISO/IEC 17024 for personal certification

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Accreditation

Accreditation is a maturing method to add confidence to the technical infrastructure

It has two recognised international bodies

International Accreditation Forum (IAF) - www.iaf.nu

International Laboratory Accreditation Cooperation (ILAC) – www.ilac.org

IAF-ILAC-ISO Memorandum of Understanding

IAF and ILAC members are improving consistency and have developed mechanisms such as the Joint Developing Countries Committee and the Cross Frontier Policy

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Peer assessment

assessment of a body against specified requirements by representatives of other bodies in, or candidates for, an agreement group

Successful examples include:

the IEC Schemes

the International Certification Network (IQNet) www.iqnet-certification.com

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Peer assessment

A new International Standard – ISO/IEC 17040

It is a process standard covering:

Human resource requirements for peer assessors

Information and documentation

Peer assessment applications

Appointment of a peer assessment team

Documentation review

On-site assessment

Reporting and review

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Other uses

Apart from providing methods to provide added confidence in certification results, accreditation and peer assessment assist in:

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

Avoiding duplicate product assessments

Providing internationally recognised management system certification

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ISO’s position

ISO is a International Standards and Guides writer

It does not undertake implementation activities

It is concerned when poor certification practice damages the reputation of ISO and its standards

In some cases added confidence through accreditation, peer assessment, or both, is appropriate

If the market place sees value in accreditation and peer assessment to provide added confidence then ISO recommends it is done in accordance with:

ISO/IEC 17011 Accreditation

ISO/IEC 17040 Peer assessment

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ISO’s position

ISO provides further guidance to ensure confidence:

ISO member’s Code of Ethics

ISO brochure on publicising your ISO 9001 and ISO 14001 certifications

The ISO 9001 ‘Auditing Kit’ at:

http://isotc176sc2.elysium-ltd.net/APG_index.html