ISO 9001 2015 Edition, “Quality management systems – Requirements,” is officially set to be released on September 15th, 2015! For all of you with ISO 9000 Certification, this new 5th Edition will present challenges and opportunities. You can pre-order your copy now from Document Center Inc. (firstname.lastname@example.org). The new ISO 9001:2015 will cost $173.00 and will be available in paper format, for pdf download, and as part of our multi-user Standards Online subscription service. We know how important this standard is to many of you. We’re here to support your use of standards like the ISO 9001 for your compliance requirements.
When it comes to transitioning from the ISO 9001 2008 to the ISO 9001 2015, there are many questions about the new requirements and when you’ll need to have made the transition. Let’s talk about your timeline first and then I’ll offer you some free resources that you may want to take advantage of for your Gap analysis and the implementation of the new update in order to meet the September 2018 deadline.
Normally, for transitioning from one edition to the next, your standards developers like ISO and IEC will recommend a three year migration period. This is certainly true for the new 5th Edition of the ISO 9001. However, you may wish to make the move the next time your registration is up for renewal. Just remember to allow for plenty of time for remediation of any non-conformities that emerge during your audit.
And there may be one additional wrinkle for you — the official adoption of the EN ISO 9001 by the European Union. Since this is a harmonized standard under Regulation (EC) No 765/2008, you may find that you need to comply with the EN Edition rather than the ISO original. If so, the harmonized list for that regulation will provide you with a “cessation of presumption of conformity” date. This is the date when the 2008 Edition will no longer be valid within the European Union and will be your “must transition by” date in that case.
Now, how to figure out what you need to do to make your transition effectively. Our first stop for clarification is the committee page for ISO TC (Technical Committee) 176 Sub-committee 2, the “owners” of the ISO 9000 Quality Standards series. You’ll find them at http://isotc.iso.org/livelink/livelink/open/tc176SC2publichttp://isotc.iso.org/livelink/livelink/open/tc176SC2public. As you scroll down their page, you’ll find a number of useful documents, including their ISO 9001 Implementation Guidance. Another useful tool is the IAF (International Accreditation Forum, Inc.) article entitled “Transition Planning Guidance for ISO 9001:2015.”
Additionally, a number of Certified Bodies and Notified Bodies have material available to assist you. BSI offers a useful transition guide, “The New ISO 9001, BSI’s Best Practice Transition Journey.” It’s a basic guide to how to set up a plan for the migration itself. Perry Johnson Registrars offers another view of the same issue with it’s “Preparing for the Change – Transition to ISO 9001:2015 .”
There’s also material directly addressing the problems of Gap analysis that you’ll need to do in order to assure that all issues in the new edition have been addressed within your organization. One of my favorites is NQA’s (National Quality Assurance) ISO 9001 2015 Transition Gap Analysis publication. TUV offers a similar review, this time including a checklist that you may find to be helpful. It’s their “ISO 9001:2015 Revision – Guidance & Self Evaluation Checklist.”
Lastly, there’s the question of which edition you should purchase. You’ll find that there are many to choose from: The ISO 9001 original, regional adoptions like the EN ISO 9001, and a plethora of national adoptions like the ASQ Q9001 here in the U.S. Reasons to pick one over the other may have to do with regulatory requirements, as noted in the discussion of the EN ISO 9001 above. Or they may have to do with the formats a standard is available in or the costs involved.
Our Document Center staff can help you understand the various criteria. And you can always take a look on our website for yourself! Just search at www.document-center.com. We’re setting up a specific page for the ISO 9000 and ISO 9001 2015 Editions, and I’ll add a link to that when it’s available. Meantime, should you have any additional questions, please get in touch with us via phone (650-591-7600), fax (650-591-7617) or email (email@example.com). We’re your Standards Experts!