Hi,

We are a start-up medical device company with a full time-staff of nine.
We have a CEO, Head of R&D, Head of RA/QA, Head of Operations and Purchasing, and a part time CFO.

We are still at the design stage of our product, and hope to test our core-technology on an experimental prototype within 2-3 months. We have regular (every 1-2 weeks) meetings on the design status of the project, essential R&D items to be purchased, QA matters, problems, etc.

We have a full set of company procedures according to ISO 9001 and 13485.

Question: Can the accumulated regular meetings "take the place of" the Management Review (MR), as the MR would be very limited in scope if we were to have one? (of course, the meetings are recorded, with Action Items, follow-up, etc. )

If so, I assume that I would need to revise our MR procedure in order to "equate" our regular meetings to the MR.

I would appreciate any input on this.

Thanks a lot.

Asherlee

We have a full set of company procedures according to ISO 9001 and 13485.

Question: Can the accumulated regular meetings "take the place of" the Management Review (MR), as the MR would be very limited in scope if we were to have one? (of course, the meetings are recorded, with Action Items, follow-up, etc. )My knowledge of 13485 is limited to say the least, so I'll stick to ISO9001 in my reply.

My take: As long as you cover the requrements in 5.6 you can carry the MR out in any way that suits you. There is in fact not even a requirement for a meeting as such.

Two useful old threads on the subject (both of them ISO 9001 related):
Can our daily operations meeting be considered as Management Review? (http://elsmar.com/Forums/showthread.php?t=4344&highlight=meeting+per+se)
Management Review of the QMS (Quality Management System) - How often (Frequency) (http://elsmar.com/Forums/showthread.php?t=5988&highlight=management+review+schedule)

/Claes

I'm in agreement with Claes and it is acceptable for ISO 13485:2003.

I agree. As long as the requirements are met it doesn't matter if its 1 or 20 meetings or a meeting at all. It's a Management Review not necessarily a meeting.

I agree,

HOWEVER

Don't forget they need to be done at "planned intervals", so you need to provide a schedule of when they occur and maintain records of each one.

Carl-

While I agree with much of what has been said, when the 2000 revision of 9001 was coming out, I asked our external auditor how they were interpreting this, and asked if our weekly production meetings would suffice. He said that in his opinion they would not, as the intent is to be able to spot trends and get an overall "where are we now" overview, which would be difficult with a short time window. We do ours quarterly, and it not only satisfies the standard, more importantly I think we get the best use of everyone's time and expertise.

The question is: "What makes the most sense for our company", not "what's the easiest way to satisfy the standard". JMHO, of course.

I just finished an auditing class for ISO13485 yesterday, and one of the hypothetical questions referenced a company that only covered two of the required topics for input in 5.6.2 in each of the quarterly meetings. The hypothetical situation required us to determine it was a minor/major finiding because the hypothetical company did not cover 5.6.2-e in every meeting (follow up actions from previous management reviews). Since you cover action items, your company's situation would have had no findings in a "hypothetical" situation, as long as it was properly reflected in your procedures.

Thanks to all of you who took the time and energy to reply.
I appreciate your comments and input.

I guess that we need to find the right balance between the letter and spirit of "the law".

Kind regards,

Asherlee