Process Review Requirement in 9001?

About ASQ's Ask the Standards Expert program and blog

Question

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

Answer

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  (KPI’S) for each quality system process and these KPI’s are periodically reviewed (at least annually) during a management review.  Any process not meeting its KPI is looked into for improvement.

There are many articles and books written on this subject and available on the web.

James Werner

Click here for more information about KPIs and here for information about management reviews.

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