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Preventive Action in ISO 9001:2015

New language encourages organizations to integrate risk analysis throughout their QMS

Mary McAtee
Thu, 05/07/2015 - 16:35
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Among the fallout from the final draft of the ISO 9001:2015 revision is a contextual change in the concept of “continual improvement.” The standard’s intent that organizations preemptively address likely issues before they become problems hasn’t changed; if anything, there’s an explicit toughening of the language to clarify what’s expected. However, some organizations are interpreting it as a justification to reduce the efforts they apply to prevention. I think this will prove to be a tactical mistake.

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The updated standard is actually looking for a more quantitative analysis of issues that could be potentially harmful if not preemptively addressed. There’s clearly a move to incorporate risk assessment elements into every practical facet of a quality management system. An organization would be well-advised to broaden its vision and scope to include opportunities beyond the obvious such as supply chain; corrective action analysis; environment, health, and safety (EH&S) incident investigation; and internal assessment findings to include objectives, metric analysis, and training competency.

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