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Open to Change: ISO 9001:2015

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This QP 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.

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