Transcript Document

International Organization
for Standardization
www.iso.org
CASCO Comms/061
2004-12-07
Product certification
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ISO Standards and Guides on
product 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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ISO/IEC documents on product certification
ISO/IEC Guide 67
ISO/IEC Guide 28
ISO/IEC Guide 53
ISO/IEC Guide 65
ISO/IEC 17030
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Background to ISO/IEC documents
Product certification activities, organizations and
systems predate ISO Standards and Guides
An identifiable need came first
Then practices, systems and organizations
developed to fulfil the need
ISO members agreed to establish international
guides that would provide general guidance for
product certification in the 1970s
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ISO/IEC documents
Reflect actual practices
Have common characteristics
Are based on a series of recognized alternative
systems
Are prepared by ISO/IEC, using a process that
fulfils the requirements of the WTO for
development of international standards and
guides
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Common characteristics
of the ISO/IEC documents
ISO/IEC documents
Not prescriptive
Not confining
Implementation requires
Statements of policy
Documentation of procedures and processes
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NEED TO DEMONSTRATE FULFILMENT OF SPECIFIED REQUIREMENTS
Functional approach
Selection
Determination
Information on
selected items
Information on
fulfilment of specified
requirements
Yes
Review and
attestation
Fulfilment of specified
requirements
demonstrated
Surveillance
needed
No
END
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ISO/IEC Guide 67:2004
Conformity assessment – Fundamentals
of product certification
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ISO/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
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ISO/IEC Guide 28:2004
Conformity assessment – Guidance on a
third-party certification system for
products
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ISO/IEC Guide 28:2004
General description of one organizational and operating
approach to product certification based on system 5 in
ISO/IEC Guide 67
ISO/IEC Guide 28:2004 covers:
Contracting
Sampling
Testing
Evaluation
Surveillance
Certification decision
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ISO/IEC Guide 28:2004
Provides model documents for
Checklist for selecting product requirements
Application for product certification
Contract
Factory inspection
Conformity certificate
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ISO/IEC Guide 53 (2005)
Conformity assessment - An approach to
the utilization of a suppliers quality system
in third-party product certification
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ISO/IEC Guide 53 (2005)
Uses a system 5 approach to product
certification and makes use of the
organizations QMS in determining the
product certification decision
Further background is given in the ISO
book – Certification and related activities
(1992)
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ISO/IEC Guide 53 (2005)
Assessment relies on:
Product testing/examination of product
At the production line
From the market; and
Ongoing conformity (not necessarily
certification/registration) with Quality
Management System (QMS) requirements
Assessment and ongoing audit of
manufacturer’s supplier quality
management system
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ISO/IEC Guide 65:1996
General requirements for bodies
operating certification systems
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ISO/IEC Guide 65:1996
Provides requirements for a body that provides
product certification activities
Organization
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Certification Services
Structure
Contracting
Behaviour
Testing
Activities
Certification decision
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ISO/IEC 17030:2003
ISO/IEC 17030:2003, Conformity assessment —
General requirements for third-party marks of
conformity
Design and application
Ownership and control
Process of issuing marks
Monitoring the use of marks
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Establishing a
product certification scheme (1)
First, determine whether there is a market
need?
Find out as much as you can about
the market’s expectations for the
product and what are the main risks
or customers expectations that
need to be met
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Establishing a
product certification scheme (2)
Second, consider alternative approaches
For example product certification, supplier’s declaration of
conformity (SDoC), etc.
Take into account the following characteristics of each option:
How well will the risk and customers’ expectations be managed
Cost/benefits, affect on final price of the product
Acceptance by the market and contribution to achieving
national legal compliance, and regional/international trade
obligations
Selecting the right alternative will contribute to the overall
competitiveness and economy efficiency of the organizations and
sector which are the subject of certification
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Establishing a
product certification scheme (3)
Third, if a product certification scheme is considered to be the best
option the following characteristics should be considered:
The business model – finance, ownership, governance, target
customers of the scheme, control, copyright of the scheme and
its mark, confidence measures (accreditation and peer
assessment), and partnerships
Do the products have identical design, assembly and are made
up of stable materials – type testing approach
The degree of risk, safety, interoperatability, reliability and
environmental performance need to be assessed for the product
– the degree of surveillance needed
What is the degree of flexibility in sourcing new and different
components and material for the product
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Establishing a
product certification scheme (4)
Finally, the scheme and certification bodies within
it should conform and employ the relevant
international product certification documents to
ensure international acceptability
In ISO these are ISO/IEC Guides 28, 53, 65, 67
and ISO/IEC 17030
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Summary
ISO/IEC documents for product certification are:
an excellent resource documents
credible – reflect actual experience
provide recognized alternatives
facilitate public confidence
support trade in products
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Further information
Thank you for your attention
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]
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