Guia De Implementacion Iso 9001:2008

ISO - ISO 9001:2008 - Implementation guidance for ISO 9001:2008

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ISO Standards

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ISO 9000 / ISO 14000

ISO 9001:2008

Implementation_guidance_for_ISO_9001:2008

Introduction and support package: Implementation guidance for ISO 9001:2008
Document: ISO/TC 176/SC 2/N836 October 2008

1.

Introduction

This Implementation Guidance hasbeen developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008. While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed. Note: To reflect the limited scope of the changes the term “implementation” isnow being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard. A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008. ISO 9001:2008 has been developed in order to introduceclarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have alreadyreceived a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS

2.

Background to the ISO9001:2008 revision process

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development. Prior to the commencement of a revision (or amendment) to a managementsystem standard, ISO/Guide 72:2001, Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following: the resultsof a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC

http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/impleme...

26/11/2008

ISO - ISO 9001:2008 - Implementation guidance for ISO 9001:2008

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176/SC2 during 2003-2004 feedback from the ISO/TC 176/Working Group on “Interpretations” the resultsof an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004” by ISO/TC 176/SC 2/WG 18 and similar national surveys. The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users. The key focuses of the ISO 9001:2008 amendment were to enhance the clarityof ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004. A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied: 1. 2. 3. No changes with...