ISO/TC 176 Quality Management Standards

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ISO/TC 176 Quality Management StandardsMeet the
Family

• Presented by
• David Zimmerman
• Project Manager
• ISO/TC 176 Secretariat

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Presentation Outline

• TC 176 Background
• Review of Management Systems Standards
• Interpretations
• Sector Activities
• Coordination with ISO/CASCO and IAF

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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
• ISOs largest committee!

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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).

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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

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The Process Approach
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Quality Systems Standards

• The Consistent Pair
• ISO 90012000 Requirements
• Forms the basis for 3rd party certification
• ISO 90042000 Guidelines for Performance
  Improvements
• Includes the requirements cited in ISO 9001 plus
  supporting guidance for improvements
• Often overlooked by users

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Quality Systems Standards CONTD

• ISO 100051995 Quality Plans
• Guidance on the use of quality plans throughout
  the quality system
• Includes sample formats
• New edition available by mid 2005
• ISO 100062003 Quality Management in Projects
• Guidance on applying quality management in
  projects
• Parallel structure to ISO 90012000

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Quality Systems Standards CONTD

• ISO 100072003 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

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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

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Supporting Tools CONTD

• ISO TR 100132001 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 100141999 Economics of Quality
• Guidance on achieving economic benefits from the
  application of quality management

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Supporting Tools CONTD

• ISO TR 100152000 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 100172003 Statistics
• what you cant measure you cant improve
• Guidance on the selection of appropriate
  statistical techniques

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Supporting Tools CONTD

• ISO 190112003 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 100022004 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

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Supporting Tools CONTD

• 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

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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

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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.

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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 !

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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.

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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

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For More Information ...

• David Zimmerman
• Project Manager
• TC 176 Secretariat
• Canadian Standards Association
• david.zimmerman_at_csa.ca
• tel [phone]
• Thank You!