Friday, February 13, 2015

Looking Under the Hood, ISO 9001:2015 Changes


After looking over the Draft International Standard (DIS) for ISO 9001:2015, it appears that ISO did more than just move things around. ISO 9001, the world's leading quality management standard, is under revision, with an updated version due by the end of 2015.Listed below are some of the changes that were made.

Additions and Relabeling
ISO 9001:2015 will now have 10 clauses instead of eight. Items have also been relabeled to better describe what should be accomplished. For example, “Purchasing” is now called “Externally Provided Products and Services” and “Document Control” has changed to “Control of Documented Information”. The Document Control label change now addresses what we always wanted it to: To make sure the information was controlled not just the piece of paper.

Preventive Action
Expect a few other rather significant changes in ISO 9001:2015, with one being Preventive Actions. The current Preventive Action (8.5.3) has always been perceived as weak due to it being a basic rewording of Corrective Action. Now, it has moved forward to the Planning Area (6.1) and incorporates what used to be Quality System Planning (5.4.1). It is a logical pairing of the two and a welcome modification.

QMS Strengths
Your Quality Management System (QMS) gains some considerable horsepower with the strengthening of Risk Analysis in the planning process. Had a stronger emphasis been placed on Risk Analysis in product planning and design, QMS could have been enhanced a bit more. And, speaking of horsepower, management representatives should like clause 6.2, “Quality Objectives and Planning to Achieve Them”. At MMTC, we have been preaching for many years that Quality Policy and Quality Objectives need to cascade down to the floor level. Many of you see that disconnect on a daily basis. “Quality Objectives and Planning to Achieve Them” puts a bit more torque in your efforts to get a Quality Policy that actually works.

There are many more features, both major and minor, to discuss with ISO 9001:2015. As time progresses, we will cover more, dig a little deeper, kick the tires and peek into the interior.

For more information on ISO, tools and methodologies, contact MMTC at 888.414.6682 or via email at Find upcoming seminars at

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