If you have not heard, ISO 9001 has been revised. It was actually planned for release in 2013, but lots of feedback and additional changes has made the committee push back to 2015. You can guarantee a revision to any QMS standard every 6 years with official release on the 7th, so this one is right on track. Generally when it comes to revisions, QMS standards go in a defined cycle; small change then big change. Since the 2008 revision was very minor (and unnecessary if you ask me), the 2015 revision lives up the cycle! There are BIG changes coming down the road, but mostly administrative in nature. If you remember, the changes from the 1994 version to the 2000 version saw the outline shrink from over 20 sections to just 8. It reduced required documented procedures from 16-20 (depending on the company) down to only 7, including the manual. The new version expands the sections from 8 to 10, and moves requirements around all over the sections. Just when you memorized where things are in the current version, you must again train yourself to new locations!
• Section 4 is still an outline of the QMS, now tentatively titled Context of the Organization, but basically the same as section 4 in the 2008 version.
• Section 5 is now tentatively called Leadership and includes most of the old section 5 stuff (policy, organization, etc.).
• Section 6 is now tentatively called Planning and includes Risks and Resources. Oh-oh…I said RISKS didn’t I? Yep, get ready!
• Most of section 7 (Product Realization) moves to section 8 (tentatively called Operations) just to mess with us. That is the easiest change to grasp, except calibration (7.6) was moved to a new section.
• Preventive Action (previously 8.5.3) is mentioned and referenced throughout the standard, but there is no reserved section to describe its content. Poor PA…you will be missed but not forgotten.
• Section 9 (newly added) is tentatively called Performance Evaluation and includes things previously in 8.1 and 8.2 in the 2008 version, but adds Management Review (5.6) and calibration (7.6).
• Section 10 (newly added) includes section 8.3, 8.4 and 8.5 of the 2008 version, but lumps Control of Nonconforming Product Control and Corrective Action together! That’s right…its now up to each company to define how they differ and which course to take based on the condition. And again, a formal requirement for Preventive Action (8.5.3) is no longer mentioned.
So, there are changes coming down. But don’t worry…the ISOMetrix team is putting together plans to minimize the work needed to conform to the new requirements and will be sending them out soon. It appears CB’s (Certification Bodies) will be allowing at least a 2 year transition period to allow for training and effective updates to meet the new outline. So feel free to give us a call or email with your questions and we will be happy to discuss it with you.