ISO TC 176 Quality Management Standards Meet the Family

ISO/TC 176 Quality Management Standards “Meet the Family” ISO TC 176 Update - BIS Presented by David Zimmerman Project Manager ISO/TC 176 Secretariat

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

TC 176 Background t Scope: Generic quality management systems and tools. t Vision: Facilitate world trade and contribute to the improvement of individuals and organizations. t Membership (95): 75 Participating Countries, 21 Observing Countries, 36 Liaison organizations – ISO’s largest committee! ISO TC 176 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). ISO TC 176 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 ISO TC 176 Update - BIS

The Process Approach ISO TC 176 Update - BIS

Quality Systems Standards The “Consistent Pair” t ISO 9001: 2000 – Requirements Ø Forms the basis for 3 rd party certification t ISO 9004: 2000 – Guidelines for Performance Improvements Ø Includes the requirements cited in ISO 9001 plus supporting guidance for improvements Ø Often overlooked by users ISO TC 176 Update - BIS

Quality Systems Standards t CONT’D ISO 10005: 1995 – Quality Plans Ø Guidance on the use of quality plans throughout the quality system Ø Includes sample formats Ø New edition available by mid 2005 t ISO 10006: 2003 – Quality Management in Projects Ø Guidance on applying quality management in projects Ø Parallel structure to ISO 9001: 2000 ISO TC 176 Update - BIS

Quality Systems Standards t CONT’D ISO 10007: 2003 – Guidelines for Configuration Management Ø can be used to meet the product identification and traceability requirements specified in ISO 9001 Ø applies over the life cycle of a product, its configuration items, and related product configuration information ISO TC 176 Update - BIS

Supporting Tools t ISO 10012 – Measurement management systems Ø Includes requirements and guidance on how to manage measurement processes and metrological confirmation of measuring equipment. Ø Highlights the quality management requirements of a measurement management system to ensure that metrological requirements are met ISO TC 176 Update - BIS

Supporting Tools t CONT’D ISO TR 10013: 2001 – Documentation Ø Guidelines for managing the documentation needed in an effective QMS Ø Including examples of document hierarchy Ø Can also be use for other management systems – eg, Environment, OHS t ISO TR 10014: 1999 – Economics of Quality Ø Guidance on achieving economic benefits from the application of quality management ISO TC 176 Update - BIS

Supporting Tools t CONT’D ISO TR 10015: 2000 – Training Ø 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 Ø “what you can’t measure you can’t improve” Ø Guidance on the selection of appropriate statistical techniques ISO TC 176 Update - BIS

Supporting Tools t CONT’D ISO 19011: 2003 – Auditing Ø 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 Ø New initiative in the area of customer satisfaction, a key feature of the ISO 9000 Ø Forms part of a package of customer satisfaction guidance ISO TC 176 Update - BIS

Supporting Tools CONT’D Customer Satisfaction Standards Under Development … t ISO 10001 – Market-Based Codes of Conduct Ø To prevent customer dissatisfaction by encouraging organizations to operate fairly in its dealings with its customers t ISO 10003 – External Dispute Resolution Systems Ø Focus on how to handle customer complaints when internal system is not successful ISO TC 176 Update - BIS

TC 176 – Interpretations Working Group t t 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 TC 176 Update - BIS

TC 176 Sector Activities TC 176 encourages effective liaisons to improve the uptake of TC 176 products t 12 Internal Liaisons including: IEC (JTC/SC 7 and TC 56), CASCO, TC 69 (statistics), TC 207 (environment), TC 210 (medical devices), TC 212 (labs) t 23 External Liaisons including: AKMS, ASQ, BIPM, EFQM, IAEA, IAF, ILAC, INLAC, IQNet, etc. t ISO TC 176 Update - BIS

Current Sector Applications t 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) t & More ! t t t t ISO TC 176 Update - BIS

Coordination with ISO CASCO and the International Accreditation Forum (IAF) t 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. ISO TC 176 Update - BIS

The Future t t 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 ISO TC 176 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! ISO TC 176 Update - BIS