Process Review Requirement in 9001?

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Is there a requirement in the new ISO 9001:2015 standards for annual monitoring/reviews of processes? What are any such requirements for process reviews?


First, there is no requirement to do anything annually.  Rather it is an expectation to do certain things such as calibration at least annually. The subject requirement is in section 9.3 Management review. Specifically section 9.3.2 Management review inputs includes at part (3) “process performance and conformity of product and services”.

What is commonly done is to create key performance indicators (KPIs) for each quality system process and these KPIs are periodically reviewed (at least annually) during a management review.  Any process not meeting its KPI is looked into for improvement.

James Werner

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