Management Review "Hoops"

I've read several articles online by folks complaining that management isn't taking management reviews seriously (required by ISO 9001/AS9100 sec. 9.3, “Management Review”). One such BLOG article was titled “What's so bad about Management Review?

Upon delving into the article (and its associated linked BLOG entries), the author's “real” complaint seems to be that management is “pencil whipping” the “Management Review” RECORD for the ISO 9001/AS9100 or ISO 13485 auditors. From the auditor's perspective, this record reflects the only management review performed (i.e., if it's not recorded. it didn't happen).

In reality, the management at every company I've visited is continuously monitoring the performance of their quality management system. One company, that immediately comes to mind, has video displays allowing management to continuously monitor the performance of various processes. This data directly relates to the most critical aspects reflecting the effectiveness of the QMS. Waiting until the end of the day, week, or even year would be akin to driving by only looking in your rearview mirror.

Ultimately, it's not that management isn't taking “Management Reviews” seriously. It's that management correctly views taking the time to create a RECORD simply to satisfy a non-value-added, but necessary administrative activity (i.e., required by ISO 9001/AS9100 sec. 9.3), as one to be minimized.

IF management were to record every detail of what they reviewed in the QMS through the course of a year (or even monthly) it would probably fill a large 3-ring binder! And be of NO value to anyone… other than an ISO 9001/AS9100 or ISO 13485 auditor.

Some of the issues/concerns identified in the article include:

  • Senior management not present
  • Reviews occurring infrequently
  • No established agenda
  • Insufficient or irrelevant information presented

All of the above issues were identified by the QMS auditor(s) through an examination of “Management Review” RECORDS. Which does not reflect the undocumented hourly, daily, or weekly management reviews that actually took place.

It should be noted that some CB (Certification Body) auditors require that an attendance list & agenda be included in the management review record… even though it is not specifically required by the standard. And some CB auditors also require management reviews to be performed annually (as a minimum)… even though this is not stated in the standard. These are simply additional management review “hoops” imposed by those auditors.

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