International Organization for Standardization

www.iso.org
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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

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Functional approach

Selection

Information on selected items

Determination

Information on fulfilment of specified requirements

Yes Review and attestation

Fulfilment of specified requirements demonstrated

Surveillance needed

No

END
Product certification 7

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 manufacturers 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 Structure Behaviour Activities Certification Services Contracting Testing 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 markets 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, suppliers 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 drake@iso.org
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