1 Product certification CASCO Comms/061 2004-12-07 www.iso.org www.iso.org International Organization International Organization for Standardization for Standardization
Dec 23, 2015
1 Product certificationCASCO Comms/0612004-12-07
www.iso.orgwww.iso.org
International Organization International Organization for Standardizationfor Standardization
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ISO Standards and Guides on
product 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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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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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
ISO/IEC documents
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Common characteristicsof 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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Fu
nctio
nal ap
pro
ach
NEED TO DEMONSTRATE FULFILMENT OF SPECIFIED REQUIREMENTS
SelectionInformation on selected items
DeterminationInformation on
fulfilment of specified requirements
Review and attestation
Fulfilment of specified requirements demonstrated
Surveillance needed
Yes
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
Organization
Structure
Behaviour
Activities
Certification Services
Contracting
Testing
Certification decision
Provides requirements for a body that provides product certification activities
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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 aproduct 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 aproduct 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 aproduct 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 aproduct 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