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ISO/TC 176 Quality Management Standards “Meet the Family”

ISO/TC 176 Quality Management Standards “Meet the Family”. Presented by David Zimmerman Project Manager ISO/TC 176 Secretariat. Presentation Outline. TC 176 Background Review of Management Systems Standards Interpretations Sector Activities Coordination with ISO/CASCO and IAF.

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ISO/TC 176 Quality Management Standards “Meet the Family”

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

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

  3. 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! ISO TC176 Update - BIS

  4. TC 176 – Strategic Plan “Horizon 2010” • 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). ISO TC176 Update - BIS

  5. 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 ISO TC176 Update - BIS

  6. The Process Approach ISO TC176 Update - BIS

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

  8. Quality Systems StandardsCONT’D • 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 • ISO 10006:2003 – Quality Management in Projects • Guidance on applying quality management in projects • Parallel structure to ISO 9001:2000 ISO TC176 Update - BIS

  9. Quality Systems StandardsCONT’D • 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 ISO TC176 Update - BIS

  10. Supporting Tools • 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 ISO TC176 Update - BIS

  11. Supporting ToolsCONT’D • 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 • ISO TR 10014:1999 – Economics of Quality • Guidance on achieving economic benefits from the application of quality management ISO TC176 Update - BIS

  12. Supporting ToolsCONT’D • 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 • ISO TR 10017:2003 – Statistics • “what you can’t measure you can’t improve” • Guidance on the selection of appropriate statistical techniques ISO TC176 Update - BIS

  13. Supporting ToolsCONT’D • 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 • 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 ISO TC176 Update - BIS

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

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

  16. 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) • 23 External Liaisons including: AKMS, ASQ, BIPM, EFQM, IAEA, IAF, ILAC, INLAC, IQNet, etc. ISO TC176 Update - BIS

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

  18. Coordination with ISO CASCO and the International Accreditation Forum (IAF) • 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. ISO TC176 Update - BIS

  19. The Future • 23rd ISO/TC 176 annual plenary meeting in Panama 3rd 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 ISO TC176 Update - BIS

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

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