Will Risk Analysis be a Requirement of ISO9001:2015?

The draft versions of the ISO9001:2015 quality management standard contain much more language about risk analysis than the ISO9001:2008 version does. What does this mean for companies new to the ISO9001 quality standard, or transitioning to ISO9001:2015?

Although the final version of the new 2015 standard has not yet been released, based on draft versions it does not appear that a full-on risk analysis program will be required. However there is language in the new standard that says you “shall” take risk analysis factors into account when doing certain things, such as product development.

Risk analysis can result in both negative risks and positive risks, which most people call opportunities. It’s good to start thinking about the risks and opportunities you’re faced with in the various processes within your business. What risks are present? What risks are acceptable? Which ones are not acceptable? How will you deal with unacceptable risks?

One aspect of the new ISO9001:2015 standard is the elimination of the requirement to have a “preventive action” procedure. Preventive action and risk analysis and mitigation are closely related, so you’ll still have to think about ways to prevent nonconformances within your organization.

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