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ISO 9001:2008

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Title: ISO 9001:2008


1
ISO 90012008
  • Amendments Small Changes
  • Improved language
  • Paul Palmes
  • Mexico City
  • 03/09/2007

2
Paul C Palmes, CQM CQABusiness Standards
Architects, Inc.
  • Vice Chair, Membership Chair, US TAG to TC 176
  • US Lead Delegate, ISO 10014
  • Author, Process Driven Comprehensive Auditing
    and Self Directed Work Teams A Case study of
    Courage and Culture Change
  • ANAB, Quality Review Board
  • OCEG, Steering Committee
  • IAF Conformity Assessment Group
  • The Auditor Newsletter, Editorial Board

pdcauditing.com
3
Do Least Harm
  • Five Year Revision Cycle
  • ISO 9001 Revision Process
  • TC 176 Chaired by CSA, Canada
  • SC 1 Concepts and Terminology, Chaired by AFNOR,
    France
  • SC 2 Quality Systems, Chaired by BSI, UK
  • SC 3 Chaired by Netherlands

4
Do Least Harm
  • NWIP New work item Proposal
  • Scope Purpose, etc.
  • Balloted, and if accepted, call for experts.
  • Each country sends a technical expert
  • Convener chosen Working group established
  • CD Produced.
  • 3 Month ballot for comment.
  • Most of the development work takes place here.
  • DIS Produced
  • 5 Month ballot for comment Must be accepted by
    67 of those voting (or less than 25 negative)
  • FDIS Produced
  • 2 month ballot for acceptance and editorial
    comment only.

5
Do Least Harm
  • How do you begin to address a NWI?
  • Design Specification
  • Scope, expected impact on the user community and
    rationale.
  • The WG cannot stray from the Specification
  • Do Least Harm
  • The 2000 revisions approach is still new
  • Transition to 2000 required new thinking,
    resources
  • Another major upgrade would stress the user
    community, many of whom are still at some level
    of transition to 2000.

6
When?!?
  • ISO 90012008 Release Timeline
  • DIS Released 9/1/07
  • WG to Address Comments 5/15/2008
  • FDIS Released 7/15/08
  • Publication 10/08
  • Is the Consistent Pair in jeopardy?

7
Clarifications to 2000 revision
  • ISO 90012000 Draft International Standard

8
Summary
  • Design Specification driven by review of
  • Interpretations 2000 2006
  • Consistency - Language
  • Comments
  • User Surveys
  • 2008 Amendment fulfills its primary Design
    Specifications
  • Consistency and Clarification

9
Impact and Improvement
  • Minimal operations impact
  • Refine/revise your Quality Manual
  • Examine the effect of where appropriate
    elements
  • Suggestions
  • Use the amendments to simplify your QMS
  • Eliminate or demote legacy documentation
  • Use 9008 revisions to revisit process and systems
    training for consistency and clarity

10
Thank You
11
Paul Palmes
  • Mr. Palmes received his BS in Education
    from Wittenberg University in Springfield, Ohio
    and his MA in Administration from Gonzaga
    University in Spokane, Washington.
  • President of Business Standards Architects, Inc.
    in Fargo, North Dakota, Palmes is a Senior member
    of ASQ, a Certified Quality Manager and BSI
    Certified Quality Auditor
  • For the past 20 years his work as a specialist
    in quality management and world-class quality
    systems has enabled many organizations to attain
    ISO 9001 registration and many others to improve
    profitability and culture.  As a member, now vice
    chair and membership chair of US TAG to ISO TC
    176, Palmes was actively involved in the 2000
    revision of the ISO 9001 quality standard.  He
    represented the United States as lead expert
    concerning the economics of quality, working to
    revise and upgrade international ISO guidance
    standard 10014 as a member of the national
    delegation. He also serves on the quality board
    of the ANSI-ASQ National Accreditation Board
    (ANAB), as US TC 176 Liaison to the ISO 9001
    Assessment Group (IAG) of the International
    Accreditation Forum (IAF) and on the Steering
    Committee of the Open Compliance and Ethics group
    (OCEG). Experience in corporate lifecycle
    analysis, strategic planning and leadership
    transition is also of special importance as he
    works to maximize potential and communication
    within organizations. 
  • His publications include two books, Process
    Driven Comprehensive Auditing, and The Magic of
    Self Directed Work Teams, published by ASQ Press,
    and numerous articles in Quality Progress, The
    Auditor Newsletter, and ISO Management Systems
    magazines.
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