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FDA Compliance

New ISO 9001 This Fall

Published: Monday, July 7, 2008 - 19:24

(ISO: Geneva) -- A new edition of ISO 9001 is being submitted for voting as a final draft international standard. Subject to formal approval by the ISO membership, the publication of the revised version is expected to be published this fall.

The proposed ISO 9001:2008 doesn’t introduce additional requirements compared to the last edition in 2000 and doesn’t change the intent of ISO 9001:2000.

The draft international standard was approved at the May 19–23, 2008, meeting of ISO technical committee ISO/TC 176—“Quality management and quality assurance,” held in Novi Sad, Serbia, and hosted by ISS, the Serbian national standards body. ISO 9001 will be circulated in July as a final draft, on which ISO’s national member bodies as a whole may vote.

ISO 9001 provides the requirements for a quality management system (QMS), which is a framework for an organization to control its processes to achieve objectives including customer satisfaction, regulatory compliance, and continual improvement. Organizations that implement the standard can choose to have their QMS independently certified as conforming to the requirements of ISO 9001, as a means of increasing the confidence of their business partners, customers, and regulators in their products and services.

Although certification isn’t compulsory, it’s estimated that more than one million ISO 9001 certificates have been issued to organizations in 170 countries. The new edition will not require any specific reassessment for certification.

ISO 9001:2008 will be the fourth edition of the standard, which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO’s rules for the development of standards require their periodic review. Compared to the 2000 revision, ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 standard for environmental management systems.

To accompany the publication of the new versions, ISO is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to frequently asked questions. ISO is collaborating with the International Accreditation Forum (IAF) concerning accredited certification.

ISO 9001 is one of 17 standards (plus a corrigendum) developed by ISO/TC 176 on quality management supporting tools. These include ISO 9004:2000—“Quality management systems—Guidelines for performance improvements,” which is undergoing revision and expected to be published as a new edition in 2009.

For more information, visit www.iso.org/iso/pressrelease.htm?refid=Ref1138.

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