Monday, January 17, 2011

ISO/FDIS 9001:2008 Overview

ISO/FDIS 9001, the final draft of the upcoming ISO 9001:2008 standard, has been published and is available for purchase from both ANSI and the American Society for Quality (ASQ). Pending formal approval of the draft by the ISO membership, publication of the ISO 9001:2008 standard is expected in October or November of this year. According to a June 17th press release from the International Organization for Standardization (ISO), “The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.” ISO’s process does not allow for changes to documents in the FDIS stage.
The ISO membership either votes to approve and publish it, or votes against publication, so no further changes are expected between the FDIS and the ISO 9001:2008 standard.
While the clause numbering has not changed, and no new requirements have been added, there are numerous clarifications to the requirements. While many of the clarifications are only rearrangements of existing text and punctuation, others involve additional notes and text. It is possible that a previous misunderstanding of a requirement, or a partial fulfillment of a requirement, will be identified during an audit to the new standard.
Companies’ management and/or management representatives should review ISO 9001:2008, and ensure that their quality management system effectively addresses the clarified requirements. In addition, internal audits should be conducted to ISO 9001:2008.
In mid-August of 2008, ISO stated that it “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.”

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