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Do Management Review records have to be on a controlled form?

QE1993

Involved In Discussions
#1
I have a controlled high-level procedure on our requirements to conduct management reviews and what the required inputs and outputs are; however, I do not specify the record format.

Currently, our record of management review is the compiled power point presentation dock (with all the inputs and outputs on it) converted to adobe format and added to our quality software's management review portal. The powerpoint is not form controlled; however we do consider it a quality record and maintain it per our higher level Control of Records procedure. Could it be a problem that it is not format controlled?

We have yet to be dinged on this, but it's something that has always been on the back of my mind.
 

pziemlewicz

Involved In Discussions
#2
The format does not need to be controlled as long as it covers all of the elements identified in clause.

That said, I did get an OFI once for not capturing "minutes" along with the presentation: attendees, discussions, and actions. We solved this by printing (3x/pg) handouts and adding notes to surrounding the discussions; the marked up copy became the record.
 

QE1993

Involved In Discussions
#3
The format does not need to be controlled as long as it covers all of the elements identified in clause.

That said, I did get an OFI once for not capturing "minutes" along with the presentation: attendees, discussions, and actions. We solved this by printing (3x/pg) handouts and adding notes to surrounding the discussions; the marked up copy became the record.
Ok, that's good to know. I do have an "Attendees" slide on the Powerpoint. Maybe I should have them sign next to their name.
 
#5
The format does not need to be controlled as long as it covers all of the elements identified in clause.

That said, I did get an OFI once for not capturing "minutes" along with the presentation: attendees, discussions, and actions. We solved this by printing (3x/pg) handouts and adding notes to surrounding the discussions; the marked up copy became the record.
Are you sure?
In 7.5 States that all documents needed into the management system, have to be controlled.
Or am I wrong?
Other opinions ?
 

Ed Panek

VP QA RA Small Med Dev Company
Trusted
#6
We do ours in a memo and assign tasks. The next year MR will capture any deviations. MR is intended to be a high-level review of the effectiveness of the QMS.

We also have a document titled QA Planning where we in detail discuss who what where when and how. We update that quarterly. This is document controlled. ISO states management shall provide adequate resources for the QMS. This plan is detailing the examples of those resources.
 
#8
Are you referring to ISO 13485:2016? 7.5 is related to Production / Service Provision. Management Review is covered in 5.6.
Ronen,

Sorry, I say for 9001, but the foundation are the same, documentation need control, as Ed Panek confirmed.
Take a closer look at control of documents.

Regards
 

pziemlewicz

Involved In Discussions
#9
The controlled document should be the process/procedure of how management review happens at your company.

The minutes of the meeting are a record, which must also be controlled, but it is up to the company to define the format. Just make sure the inputs from 5.6.2 and outputs from 5.6.3 are all covered.
 
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