Open to Change

Abstract:This article discusses expected revisions in 2015 to ISO 9001, the international consensus standard for quality management systems (QMS). The author considers how these revisions might affect several large sectors, including automotive, aerospace, and medical devices. The article explains how the ISO standard revision process leads to the minimum set of requirements for, in the case of ISO 9001, a functional QMS for all types of organizations. As such, it cannot and will not have best-in-class requirements or methods from various sectors because these are neither generic nor applicable to all. Hence, the best a sector can do if it elects to use ISO 9001 at all is to take the document as the starting point for a more complete set of requirements needed to achieve the desired quality levels, typically aimed at its supply chains, at least for the highest-risk suppliers. Various aspects of the draft revision are discussed in terms of how different sectors may need to take those changes into …

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If there are truly as many instances of "consider" and "as applicable" in the 2015 revision as this article seems to indicate, I can see I will have additional difficulty making sure getting all of our usual quality requirements written into our contracts.
--Richard Ward, 07-23-2015


This article provided good but incomplete information on an unknown entity. The author has provided a little more light onto the shadowed outline of this criticaal subject. I don't think we will really know what this new revision is until some time next year when an auditor finds that one clause everyone else overlooked.
--Tom Fessenden, 07-14-2015



--Muthu, 07-13-2015


Dan Reid has provided a good summary of expected changes to the 2015 edition of ISO 9001. He has noted several of the important differences, perhaps the most significant of which is the new, mandatory terminology in the standard. While the motive of ISO to generalize the applicability of ISO 9001 to broader business sectors, much of the new terminology is unfamiliar to current ISO 9001 users. This may result in much confusion during implementation and in substantial costs to the organization attempting to use the new version as personnel will need more training and understanding of the new requirements (e.g., risk, innovation) in order to effectively implement the standard. It remains to be seen if the new terminology actually achieves the value that ISO suggests or will it cause some users to decline further.
--Gary L. Johnson, 07-11-2015


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