ISO/IEC Toolbox for Conformity Assessment

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ISO/IEC Toolbox for
Conformity Assessment
Mr. Adrian O’Connell
ISO representative
General Manager, Operations
Standards Australia
Regional ITU Consultation on Conformance Assessment
and Interoperability for the Asia-Pacific Region
Sydney (Australia), 16-17 September 2010
Agenda
9 September 2010
1
What is the ISO/IEC Toolbox for Conformity Assessment?
2
Where does conformity assessment fit in?
3
The ISO contribution to conformity assessment
4
ISO/CASCO
5
Specific standards and guides
6
Conclusion
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What is the
ISO/IEC Toolbox
for Conformity
Assessment?

A suite of International Standards and Guides that set out
general requirements for conformity assessment activities,
such as:
–
–
–
–
–
–
–

Product testing
Inspection
Self-declaration of conformity
Product certification
Management system auditing and certification
Accreditation and peer assessment
Mutual recognition of test and inspection results
Produced by ISO’s policy committee on conformity
assessment (ISO/CASCO)

Recognised as the accepted international standards for
conformity assessment by the WTO Technical Barriers to
Trade (TBT) Committee

Adopted in most countries and used widely in many sectors,
including telecommunications
9 September 2010
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Where does
conformity
assessment fit
in?
Conformity assessment
1st party
•
After standards publication
•
Various determination methods
– Calibrate
– Test
– Inspect
– Audit
– Examine
– Evaluate
THE TECHNICAL
INFRASTRUCTURE
Policy
Measurement
Documentary standards
Claims of conformity
•
Determination of whether a
product conforms
•
Can result in conformity marking
of the product
Accreditation and peer
assessment
•
9 September 2010
Supplier’s
declaration of
conformity
2nd party
Purchaser
audits the
supplier
3rd party
Independent
certification
ISO/IEC Standards and Guides
written by ISO
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Australia’s
Technical
Infrastructure
Bodies
Policy and regulation
Measurement
Documentary standards
Various government owned and
private testing, inspection and
certification facilities
Conformity assessment bodies
Accreditation bodies
9 September 2010
5
The ISO
contribution to
conformity
assessment
9 September 2010

World Standards Cooperation (WSC) - leading international
standards bodies

Multi-discipline and cross-sector,
including conformity assessment

For electrotechnology

For telecommunications

Collaborate to meet the challenges of converging technologies

Use of common conformity assessment standards
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ISO’s structure
Notes
 Members from 163
countries, covering
98% of world GNI
and 97% of world
population
 Over 18,000
international
standards based on
consensus
 195 active technical
committees with
3,238 technical
groups, 50,000
experts
 Central Secretariat
in Geneva with 153
FTE staff
9 September 2010
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ISO/CASCO
Notes
 111 ISO members are
represented in
CASCO
 18 international
organizations are
liaison members,
including ITU and
IEC
 Undertake policy and
technical work, and
internal and external
engagement and
promotion
 Structured as a
continual
improvement cycle
9 September 2010
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ISO/CASCO
Standards and
Guides

Fundamentals of global conformity assessment
− Vocabulary and general principles (ISO/IEC 17000)
− Functional approach to conformity assessment
•
Selection
•
Determination
•
Review and decision
•
Attestation
•
Surveillance
− Common elements to ensure consistent approaches
(Impartiality, Confidentiality, Complaints and appeals,
Disclosure of information; and Management systems –
ISO/PAS 17001-5)
− Code of good practice for conformity assessment
(ISO/IEC Guide 60)
9 September 2010
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ISO/CASCO
Standards and
Guides
 Conformity assessment determination methods
− Testing and calibration (ISO/IEC 17025)
− Inspection (ISO/IEC 17020)
− Other methods including in standards below
 Claims of conformity
− Self or suppliers declaration (ISO/IEC 17050)
− Product, process and service certification (ISO/IEC
Guides 28, 53, 65 and 67)
− Management systems audit and certification (ISO/IEC
17021)
− Personnel examination and certification (ISO/IEC
17024)
− Marks of conformity (ISO/IEC 17030)
9 September 2010
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ISO/CASCO
Standards and
Guides
 Assurance of claims of conformity
− Accreditation (ISO/IEC 17011)
− Peer assessment (ISO/IEC 17040)
− Proficiency testing (ISO/IEC 17043)
 Mutual recognition of conformity assessment results and
other guidance
− Mutual recognition of conformity assessment results
(ISO/IEC Guide 62)
− How to write technical regulations and standards for use
in conformity assessment (ISO/IEC 17007)
9 September 2010
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Other ISO/CASCO
activities

Advice and input into the development of sector
applications of conformity assessment standards by ISO
and IEC Technical Committees through the CASCO
Technical Interface Group (TIG)

Outreach to industry and regulatory groups (e.g.
automotive, aerospace, railways) through their participation
in CASCO Strategic Alliance and Regulatory Group (STAR)

Electronic newsletter
(www.iso.org/sites/eNewsletters/CASCO/archive.html)

Annual survey of management system certificates
(currently in excess of 1 million certificates world wide)

Annual workshops – 2010 will be on conformity
assessment and risk management
9 September 2010

Development of information on market surveillance

Training and capability building in developing countries
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Conclusion

ISO/CASCO standards and guides on conformity
assessment are the accepted basis for testing, inspection
and claims of conformity around the world

Adoption and use of these standards and guides will
− Enable compliance with WTO obligations and show a
commitment to good conformity assessment practice
− Provide a common basis on which to compare products
and make investment decisions
− Provide a traceable path for testing and inspection
results and claims of conformity, whether those claims
be 1st party (suppliers declarations of conformity), 2nd
party, or 3rd party (product certifications)
− Increase consumer and regulator confidence and
acceptance of products
− Be a mechanism to facilitate development and trade
9 September 2010
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