1. ISO/TC 176 Quality Management Standards “Meet the Family” Presented by David Zimmerman Project Manager Project Manager ISO/TC 176 Secretariat

2. ISO TC176 Update - BIS Presentation Outline  TC 176 Background  Review of Management Systems Standards  Interpretations  Sector Activities  Coordination with ISO/CASCO and IAF

3. ISO TC176 Update - BIS TC 176 Background  Scope: Generic quality management systems and tools.  Vision: Facilitate world trade and contribute to the improvement of individuals and organizations.  Membership (95): 75 Participating Countries, 21 Observing Countries, 36 Liaison organizations –ISO’s largest committee!

4. ISO TC176 Update - BIS TC 176 – Strategic Plan “Horizon 2010” t Mission: -Identify and understand the needs of society, users, and of their customers. -Develop, support and improve generic or sector QMS standards. -Safeguard the integrity of its standards in their use, including conformity assessment activities. -Minimize proliferation of QMS standards. -Contribute to the compatibility of management system standards (MSS).

5. ISO TC176 Update - BIS ISO/TC 176 Management System Standards ISO 9000 – Fundamentals + Vocabulary - Sets the stage for the other standards in the TC 176 family - Fundamentals – rationale & process approach - Definitions – provides a clear understanding of terms used in our quality management system standards

6. ISO TC176 Update - BIS The Process Approach

7. ISO TC176 Update - BIS Quality Systems Standards The “Consistent Pair” t ISO 9001:2000 – Requirements  Forms the basis for 3 rd party certification t ISO 9004:2000 – Guidelines for Performance Improvements  Includes the requirements cited in ISO 9001 plus supporting guidance for improvements  Often overlooked by users

8. ISO TC176 Update - BIS Quality Systems Standards Quality Systems Standards CONT’D t ISO 10005:1995 – Quality Plans  Guidance on the use of quality plans throughout the quality system  Includes sample formats  New edition available by mid 2005 t ISO 10006:2003 – Quality Management in Projects  Guidance on applying quality management in projects  Parallel structure to ISO 9001:2000

9. ISO TC176 Update - BIS Quality Systems Standards Quality Systems Standards CONT’D t ISO 10007:2003 – Guidelines for Configuration Management  can be used to meet the product identification and traceability requirements specified in ISO 9001  applies over the life cycle of a product, its configuration items, and related product configuration information

10. ISO TC176 Update - BIS Supporting Tools t ISO 10012 – Measurement management systems  Includes requirements and guidance on how to manage measurement processes and metrological confirmation of measuring equipment.  Highlights the quality management requirements of a measurement management system to ensure that metrological requirements are met

11. ISO TC176 Update - BIS Supporting Tools Supporting Tools CONT’D t ISO TR 10013:2001 – Documentation  Guidelines for managing the documentation needed in an effective QMS  Including examples of document hierarchy  Can also be use for other management systems – eg, Environment, OHS t ISO TR 10014:1999 – Economics of Quality  Guidance on achieving economic benefits from the application of quality management

12. ISO TC176 Update - BIS Supporting Tools Supporting Tools CONT’D t ISO TR 10015:2000 – Training  Guidelines cover the development, implementation, and improvement of training systems that affect the quality of products and services supplied by an organization t ISO TR 10017:2003 – Statistics  “what you can’t measure you can’t improve”  Guidance on the selection of appropriate statistical techniques

13. ISO TC176 Update - BIS Supporting Tools Supporting Tools CONT’D t ISO 19011:2003 – Auditing  A critical part of the implementation of a management system, these guidelines cover auditing principles, audit activities and development of suitable criteria for auditor competence t ISO 10002:2004 – Complaints Handling  New initiative in the area of customer satisfaction, a key feature of the ISO 9000  Forms part of a package of customer satisfaction guidance

14. ISO TC176 Update - BIS Supporting Tools Supporting Tools CONT’D Customer Satisfaction Standards Under Development … t ISO 10001 – Market-Based Codes of Conduct  To prevent customer dissatisfaction by encouraging organizations to operate fairly in its dealings with its customers t ISO 10003 – External Dispute Resolution Systems  Focus on how to handle customer complaints when internal system is not successful

15. ISO TC176 Update - BIS TC 176 – Interpretations Working Group t Purpose is to provide interpretations on ISO 9001 using ISO member body input t WGI Convenor and Secretariat – Brazil t Over 40 requests have been processed by the WGI t An operational entity – results are posted on the TC 176 website for public use

16. ISO TC176 Update - BIS TC 176 Sector Activities  TC 176 encourages effective liaisons to improve the uptake of TC 176 products  12 Internal Liaisons including: IEC (JTC/SC7 and TC 56), CASCO, TC 69 (statistics), TC 207 (environment), TC 210 (medical devices), TC 212 (labs) IEC (JTC/SC7 and TC 56), CASCO, TC 69 (statistics), TC 207 (environment), TC 210 (medical devices), TC 212 (labs)  23 External Liaisons including: AKMS, ASQ, BIPM, EFQM, IAEA, IAF, ILAC, INLAC, IQNet, etc. AKMS, ASQ, BIPM, EFQM, IAEA, IAF, ILAC, INLAC, IQNet, etc.

17. ISO TC176 Update - BIS Current Sector Applications t ISO 13485 and ISO 13488 (medical) t ISO IWA 1(health care) t ISO IWA 2 (education) t ISO TS 16949 (automotive) t TE-9000 (tools) t TL 9000 (telecommunications) t AS 9000 and AS 9001(aerospace) t FS 9000 (financial) t & More !

18. ISO TC176 Update - BIS Coordination with ISO CASCO and the International Accreditation Forum (IAF) t TC 176 formed a Conformity Assessment Liaison Group to facilitate our liaison relationships with IAF and CASCO.  Joint Frameworks for Cooperation have been established with both of these bodies, and this group will be instrumental in coordinating TC 176 input into their work.

19. ISO TC176 Update - BIS The Future  23 rd ISO/TC 176 annual plenary meeting in Panama 3 rd Quarter 2005  Improve implementation tools  Increased Coordination with ISO TC 207 (environment) on the development of management systems standards in the ISO community  Management of issues related the credibility of the ISO 9001 standard

20. ISO TC176 Update - BIS For More Information... David Zimmerman Project Manager TC 176 Secretariat Canadian Standards Association david.zimmerman@csa.ca tel +1 416-747-2479 Thank You!