ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system'

Sebastian

Trusted Information Resource
Hello,
could you share example of decisions and actions related to this element from your MR report?
Without going into much details to ensure confidentiality.
Additionally, could you describe MR input related to this example. also without whole details?
 

John Broomfield

Leader
Super Moderator
Hello,
could you share example of decisions and actions related to this element from your MR report?
Without going into much details to ensure confidentiality.
Additionally, could you describe MR input related to this example. also without whole details?

Broadly, try thinking this way:

A. What our management system helps us do well;
B. Under what circumstances our management system did less than well.
C. What we are going to do about B above.

Put this MR report together to help keep the employees engaged in improvement.

John
 

qualitymanagerTT

Involved In Discussions
Hello,
could you share example of decisions and actions related to this element from your MR report?
Without going into much details to ensure confidentiality.
Additionally, could you describe MR input related to this example. also without whole details?

Examples of decisions: Change CB; fire the Q Manager

Examples of actions: Search for new CB & short-list 5 by end-Jun; start recruitment for new Q Manager & include a requirement that they spend no more than 30 mins during work time on the Elsmar Cove ;)
 

Randy

Super Moderator
Examples of decisions: Change CB; fire the Q Manager

Examples of actions: Search for new CB & short-list 5 by end-Jun; start recruitment for new Q Manager & include a requirement that they spend no more than 30 mins during work time on the Elsmar Cove ;)

Yep, pretty much.........In fact I did a certificate transfer yesterday where both things happened except it was the EHS Manager
 

Bev D

Heretical Statistician
Leader
Super Moderator
Examples of decisions: Change CB; fire the Q Manager

Examples of actions: Search for new CB & short-list 5 by end-Jun; start recruitment for new Q Manager & include a requirement that they spend no more than 30 mins during work time on the Elsmar Cove ;)
Hmmm. If the new Quality manager is not very well versed in quality I would hope they spend MORE than 30 minutes on the cove. If they are a hack or a troll I hope they never come to the cove.
 

FRA 2 FDA

Involved In Discussions
I'm no expert, but I'll take a crack at some examples for you. One I am going to use in our next MRM is exploring the need to move to an eQMS. One that I addressed in our last MRM was taking control of our client training materials to ensure that they are revision controlled and subjected to document control guidelines.
 

Sebastian

Trusted Information Resource
Input was originated in internal audit findings or internal issues like e.g. new remotely located facilities?
 

Tidge

Trusted Information Resource
In my mind: There is theory, there is practice, and there is practicality.

In theory: A management review is the place to motivate (to MWER) "changes" to a QMS.

In practice: MWER should probably only be notified about defects in the QMS, as they've presumably already taken responsibility for the existing QMS. Think: 'external audit finding'. There is obviously a spectrum of engagement between MWER and the QMS... I typically see "disengaged", but I have also seen examples of MWER with more 'concern'... including members of MWER that would be just as happy to scrap a QMS, as well as those who would like nothing more than to micromanage the most trivial of topics (e.g. the color of paper used in printers).

Practicality concerns: A management representative ought to (well, duh) represent to management the health of the QMS and at a high-level describe activities done in the QMS space since the last report... and be prepared to go into detail if/when asked. I don't think it would be practical to prepare to discuss the revision details of every work instruction and template that has changed in the most recent quarter... but an update on the status of any CA or NCR related to the QMS would probably be more cogent. Internal audit finding usually result in entries in the non-conformance and corrective action space, so inform MWER and let them make an assessment if they think there is a defect with the QMS.
 
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