Transcript Having confidence in certification, Graeme Drake

International Organization
for Standardization
www.iso.org
CASCO Comms/060
2004-12-07
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Having confidence in
certification
by Mr. Graeme Drake
Head of Conformity Assessment
ISO Central Secretariat
ISO CASCO/DEVCO – BIS
Regional workshop on Certification
New 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 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
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
Claims of conformity
and certification
A range of
organisations
may develop
documentary
standards. In the
ISO system each
country has one
national
standards
representative
This is the process by
which a person or
company claims a
good or service
conforms with a
standard or technical
specification
In some sectors
government
Ministries or
Departments
make and define
documentary
standards
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
Regional bodies
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
WTO Agreements
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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
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