International Organization For Standardization: 1 Product Certification

International Organization for Standardization
www.iso.org
CASCO Comms/061 2004-12-07
Product certification
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
CASCO Comms/061 2004-12-07
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
CASCO Comms/061 2004-12-07
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
CASCO Comms/061 2004-12-07
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
CASCO Comms/061 2004-12-07
Common characteristics of the ISO/IEC documents

ISO/IEC documents Not prescriptive Not confining
Implementation requires
Statements of policy
Documentation of procedures and processes
CASCO Comms/061 2004-12-07
NEED TO DEMONSTRATE FULFILMENT OF SPECIFIED REQUIREMENTS
CASCO Comms/061 2004-12-07
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
CASCO Comms/061 2004-12-07

Outlines 7 product certification systems that combine several of the following core elements related to product certification: Sampling
Testing
Evaluation Decision Licensing Surveillance
CASCO Comms/061 2004-12-07
Conformity assessment Guidance on a third-party certification system for products
CASCO Comms/061 2004-12-07
10

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
CASCO Comms/061 2004-12-07
11

Provides model documents for Checklist for selecting product requirements Application for product certification Contract Factory inspection Conformity certificate
CASCO Comms/061 2004-12-07
12
ISO/IEC Guide 53 (2005)
Conformity assessment - An approach to the utilization of a suppliers quality system in third-party product certification
CASCO Comms/061 2004-12-07
13

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)
CASCO Comms/061 2004-12-07
14

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
CASCO Comms/061 2004-12-07
15
General requirements for bodies operating certification systems
CASCO Comms/061 2004-12-07
16

Provides requirements for a body that provides product certification activities
Organization Structure Behaviour Activities Certification Services Contracting Testing Certification decision
CASCO Comms/061 2004-12-07
17
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
CASCO Comms/061 2004-12-07
18
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
CASCO Comms/061 2004-12-07
19

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
CASCO Comms/061 2004-12-07
20

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
CASCO Comms/061 2004-12-07
21

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
CASCO Comms/061 2004-12-07
22
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
CASCO Comms/061 2004-12-07
23
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
CASCO Comms/061 2004-12-07
24

International Organization For Standardization: 1 Product Certification

Uploaded by

Copyright:

Available Formats

International Organization For Standardization: 1 Product Certification

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

International Organization For Standardization: 1 Product Certification

Uploaded by

Copyright:

Available Formats

International Organization for Standardization

ISO Standards and Guides on

CASCO Comms/061 2004-12-07

ISO/IEC documents on product certification

Background to ISO/IEC documents

Then practices, systems and organizations developed to fulfil the need

CASCO Comms/061 2004-12-07

CASCO Comms/061 2004-12-07

Common characteristics of the ISO/IEC documents

Documentation of procedures and processes

CASCO Comms/061 2004-12-07

NEED TO DEMONSTRATE FULFILMENT OF SPECIFIED REQUIREMENTS

CASCO Comms/061 2004-12-07

Information on selected items

Information on fulfilment of specified requirements

Yes Review and attestation

ISO/IEC Guide 67:2004

Conformity assessment Fundamentals of product certification

CASCO Comms/061 2004-12-07

ISO/IEC Guide 67:2004

ISO/IEC Guide 28:2004

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

CASCO Comms/061 2004-12-07

ISO/IEC Guide 28:2004

ISO/IEC Guide 28:2004

CASCO Comms/061 2004-12-07

ISO/IEC Guide 53 (2005)

CASCO Comms/061 2004-12-07

ISO/IEC Guide 53 (2005)

CASCO Comms/061 2004-12-07

ISO/IEC Guide 53 (2005)

Product testing/examination of product

ISO/IEC Guide 65:1996

General requirements for bodies operating certification systems

CASCO Comms/061 2004-12-07

ISO/IEC Guide 65:1996

CASCO Comms/061 2004-12-07

Monitoring the use of marks

CASCO Comms/061 2004-12-07

Establishing a product certification scheme (1)

CASCO Comms/061 2004-12-07

Establishing a product certification scheme (2)

Establishing a product certification scheme (3)

Establishing a product certification scheme (4)

CASCO Comms/061 2004-12-07

provide recognized alternatives

support trade in products

CASCO Comms/061 2004-12-07

You might also like