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Does Management Review need to be a Formal Meeting?

#31
Jeepers, now if only the same diligent effort was put into a focus on the effectiveness of management planning and review as opposed to corralling people into a meeting when it may not be the best way!
Very well said!!!:applause:

We look at syntax, linguistics and spelling.... but pay no attention to whether the system works or not!
 
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#32
ISO TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003
This is just a guidance document and is not required.... but what you say is valid. Meetings are a very effective way to conduct reviews (provided they have the correct attendees).

I think the reason that meetings are not a requrement is that the Technical Committees did not want to ties the hands of organizations.

I have three very, very, very small clients. One is a machining center, one is a heat treater and one injection molder. All three are privately owned and the owner is the only person. One person to do sales, management and production. Can you imagine the meeting minutes if a review meeting was required?
 
J

JaneB

#33
I think the reason that meetings are not a requrement is that the Technical Committees did not want to ties the hands of organizations.
Yes. And praise be to them for that common sense! :applause:

I have three very, very, very small clients. One is a machining center, one is a heat treater and one injection molder. All three are privately owned and the owner is the only person. One person to do sales, management and production. Can you imagine the meeting minutes if a review meeting was required?
Exactly. It's one reason why someone firmly espousing a viewpoint that there must be a management review meeting and MR must be done like so or there 'must' be Role X and Role Y and Role Z present at the MR meeting is not reading it carefully enough or perhaps lacks experience of systems/organisations/companies of varying sizes.

Or has paid inadequate attention to the various statements in section 0.1, including:
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems
and in 1.2:
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
They're not there just to pad out the document.
 
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J

JaneB

#34
However, with "various level review" you can't collect feedback from everyone at the same time. Therefore, this type of review will not be as effective as face to face meeting! In addition, you need to get an agreement from everyone that your QS is effective or has same issues and require some actions.:2cents:
Just staying with the topic raised by the original poster: there's no requirement to 'get agreement from everyone' - nowhere is that said. (Pity help the world if ISO 9001 did demand that!) Again - it mandates review, but does not mandate how it shall be done, including not demanding that 'everyone' has to agree! My own opinion: not gonna happen. Nor do you have to collect feedback from 'everyone at the same time'. I can hear that you hold strong opinions on the efficacy of these things - fine. But those are opinions, not mandated by the Standard.
 
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