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ISO 9001:2008 Update

Timothy Woodcome
Director, Conformity Assessment

As you should know by now, ISO 9001:2008 has been released and requires a transition from the ISO 9001:2000 standard. The new standard was released nearly one year ago (November 14, 2008). NQA, USA has conducted over 1,200 successful audits in North America to this revised standard since that point in time, with several thousands more completed amongst the global family of NQA clients. To date, the NQA, USA volume has peaked at nearly 250 certificates transitioned in a given month. As we approach the halfway mark in the transition period we have completed nearly 40% of the North American transitions required.

For any individual or organization unfamiliar with the changes in ISO 9001:2008, several previously published NQA articles are available in the newsletter archives. Additionally, NQA has published a detailed Change Checklist identifying and commenting on all the changes in the Standard, along with an on-demand webinar outlining the pertinent details of these changes. Both of these useful tools are available by logging in here.

ISO 9001:2008 Transition - moving forward

November 15, 2009 will mark a significant milestone in this Standard's transition period. After that date, all new ISO 9001 certificates will be issued to the ISO 9001:2008 standard only. This means any new certification audits and any re-certification audits will need to be assessed to the ISO 9001:2008 standard.

As a matter of course, all ISO 9001 audits from this point forward should be conducted to ISO 9001:2008. The NQA expectations for organizations to complete the transition are quite simply:

  • Get a copy of the new ISO 9001: 2008 Standard. It is available in hardcopy or electronic versions from either ASQ (www.asq.org) or the International Organization of Standardization (www.iso.org)
  • Review the Standard for its changes. Utilize the NQA tools or the Annex B of the Standard itself to help identify areas of change.
  • Update areas of the organization's QMS as needed. This will be the output of the above process, and largely dependent upon the organization's initial interpretations and implementation strategies.
  • Document the review and analysis made, including any changes. This will create records of your QMS evolution and also facilitate the transition review.

For any organization which still holds an ISO 9001:2000 certificate, once the transition to ISO 9001:2008 has been reviewed through the normal course of an audit, NQA will re-issue the organization's certification with an ISO 9001:2008 certificate, pending any required Corrective Action Plans. It should be noted that all certified organizations must transition to ISO 9001:2008 before November 15, 2010, the date when ISO 9001:2000 becomes obsolete.

Special Note on Aerospace and Telecom Industry Sector Certifications

Organizations with ISO 9001-based certifications such as AS9100 or TL 9000 should also complete the ISO 9001:2008 transition prior to the November 2010 expiration. Both AAQG and QuEST Forum have issued formal notifications that ISO 9001:2008 may be used in conjunction with the existing revisions of AS9100 and TL9000 prior to the transition of the industry standard. TL 9000 R5.0 is released and valid for audits as of November 15, 2009; it has a one-year transition of use period. AS9100 Revision C is not yet ready for audit, and likely will include a lengthier transition period; as such many organizations will have an AS9100 Rev. B/ISO 9001:2008 interim certification. Sector Business Unit Directors will provide more detailed transition guidance as needed for these industries.

Helpful Hints on ISO 9001:2008 Implementation

A few helpful hints can also be provided for organizations through this transition time:

  • Do get a copy of the Standard. Even though the changes are not earth-shattering, there are changes you need to be aware of. Also, 4.2.3 of the Standard requires that certified organizations control documents of external origin determined by the organization to be necessary for the QMS, and ensure that relevant versions of applicable documents are available. Certainly the current ISO standard to which you wish to be certified should qualify as such a document.
  • Give the review of the new Standard the appropriate time and attention. The most direct manner would be via Management Review: 5.6.2 (f) requires organizations to review with top management any changes that could affect the quality management system. We can't think of many better examples of a change that could affect the QMS.
  • It would be acceptable to hold a 'special' Management Review meeting to focus on the review of the ISO 9001:2008 changes if your regularly scheduled meeting recently occurred, or there was not time in the regular agenda to cover this topic.
  • When reviewing and analyzing the changes, record those actions as part of your process (be it via Management Review, Internal Audits, or otherwise). Additionally utilize action items to track any follow-up needs.

Should you have any questions or concerns about the ISO 9001:2008 Standard and the transition process, please contact your NQA CSR or NQA Auditor to discuss your specific needs.

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