1. 1Product certification CASCO Comms/061 2004-12-07 www.iso.org International Organization for Standardization

2. 2Product certification CASCO Comms/061 2004-12-07 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

3. 3Product certification 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

4. 4Product certification 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

5. 5Product certification CASCO Comms/061 2004-12-07 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

6. 6Product certification 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

7. 7Product certification CASCO Comms/061 2004-12-07 Functional approach

8. 8Product certification CASCO Comms/061 2004-12-07 ISO/IEC Guide 67:2004 Conformity assessment – Fundamentals of product certification

9. 9Product certification CASCO Comms/061 2004-12-07 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

10. 10Product certification CASCO Comms/061 2004-12-07 ISO/IEC Guide 28:2004 Conformity assessment – Guidance on a third-party certification system for products

11. 11Product certification CASCO Comms/061 2004-12-07 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

12. 12Product certification CASCO Comms/061 2004-12-07 ISO/IEC Guide 28:2004 Provides model documents for Checklist for selecting product requirements Application for product certification Contract Factory inspection Conformity certificate

13. 13Product certification CASCO Comms/061 2004-12-07 ISO/IEC Guide 53 (2005) Conformity assessment - An approach to the utilization of a suppliers quality system in third-party product certification

14. 14Product certification CASCO Comms/061 2004-12-07 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)

15. 15Product certification CASCO Comms/061 2004-12-07 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

16. 16Product certification CASCO Comms/061 2004-12-07 ISO/IEC Guide 65:1996 General requirements for bodies operating certification systems

17. 17Product certification CASCO Comms/061 2004-12-07 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

18. 18Product certification CASCO Comms/061 2004-12-07 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

19. 19Product certification CASCO Comms/061 2004-12-07 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

20. 20Product certification CASCO Comms/061 2004-12-07 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

21. 21Product certification CASCO Comms/061 2004-12-07 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

22. 22Product certification CASCO Comms/061 2004-12-07 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

23. 23Product certification CASCO Comms/061 2004-12-07 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

24. 24Product certification CASCO Comms/061 2004-12-07 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