ISO 9001_2008-ok

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ISO 9001:2008 : 

ISO 9001:2008 Amendments: Small Changes Improved language Paul Palmes Mexico City 03/09/2007

Paul C Palmes, CQM; CQABusiness Standards Architects, Inc. : 

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

Do Least Harm : 

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

Do Least Harm : 

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.

Do Least Harm : 

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 revision’s 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.

When?!? : 

When?!? ISO 9001:2008 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?

Clarifications to 2000 revision : 

Clarifications to 2000 revision ISO 9001:2000 Draft International Standard

Summary : 

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

Impact and Improvement : 

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”

Thank You : 

Thank You

Paul Palmes : 

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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