1product certification casco comms/061 2004-12-07 international organization for standardization

1 Product certificationCASCO Comms/0612004-12-07

www.iso.orgwww.iso.org

International Organization International Organization for Standardizationfor Standardization


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


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


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


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


Common characteristicsof the ISO/IEC documents

ISO/IEC documents

Not prescriptive

Not confining

Implementation requires

Statements of policy

Documentation of procedures and processes


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


ISO/IEC Guide 67:2004

Conformity assessment – Fundamentals of product certification



Outlines 7 product certification systems that combine several of the following core elements related to product certification:

Sampling

Testing

Evaluation

Decision

Licensing

Surveillance



Conformity assessment – Guidance on a third-party certification system for products



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



Provides model documents for

Checklist for selecting product requirements

Application for product certification

Contract

Factory inspection

Conformity certificate


ISO/IEC Guide 53 (2005)

Conformity assessment - An approach to the utilization of a suppliers quality system in third-party product certification



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)



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



General requirements for bodies operating certification systems



Organization

Structure

Behaviour

Activities

Certification Services

Contracting

Testing

Certification decision

Provides requirements for a body that provides product certification activities


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


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



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



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



• 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


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


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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