ISO 9001: 2008 Changes between DIS and FDIS/Final

ISO has approved the FDIS (Final Draft International Standard) version of ISO 9001. The final publication is expected in the December 2008.

We are listing the changes appearing in the Final version of ISO 9001:2008, compared to the DIS version released earlier this year. Minor wording and format changes are not included.

For complete details of changes in ISO 9001: 2008 and to know how it will affect you as an ISO 9001 certified company, visit www.isohelpline.com and check our ISOhelpline Guide to ISO 9001: 2008 (1 CD).

Clause 0.2 – Process approachText added to identify a process as “an activity or set of activities.”
Clause 0.3 – Relationship with ISO 9004Revised to emphasize continual improvement and remove reference to “applicable statutory and regulatory requirements.” Specifies that ISO 9004 can be used “to move beyond the requirements of ISO 9001.”
Clause 0.4 – Compatibility with other management systemsAdded reference to Annex A, which compares ISO 9001:2008 and ISO 14001:2004.
Clause 6.2.2 – Competence, training and awarenessItem c) changed from “ensure that the necessary competence has been achieved” to “evaluate the effectiveness of the actions taken.”
Clause 7.6 – Control of monitoring and measuring equipmentChanged “and/or” to “or” in item a), so it now reads “be calibrated or verified.”
Clause 8.3 – Control of nonconforming product“Where practicable” changed to “where applicable.”
Clause 8.4 – Analysis of dataReferences to other clauses updated in items b), c), and d).
Clause 8.5.2 – Corrective actionItem f) updated to read “reviewing the effectiveness of the corrective action taken.”
Clause 8.5.3 – Preventative actionItem e) updated to read “reviewing the effectiveness of the preventative action taken.”