Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485

[compliance]

I am looking for an example of either a Quality manual, or a QMS flow (or process map) that addresses MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485:2003. Here's the thing.........I would like to see an example that does not regurgitate the regs and is really a process approach. Our registrar has told us they don't want to see a manual larger than 10 pages. Anyone done this yet?

[Aaron Lupo]

Originally Posted by compliance

I am looking for an example of either a Quality manual, or a QMS flow (or process map) that addresses MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485:2003. Here's the thing.........I would like to see an example that does not regurgitate the regs and is really a process approach. Our registrar has told us they don't want to see a manual larger than 10 pages. Anyone done this yet?

Compliance,

Here isa basic exampl of a flow chart that I put in the QM for the last company I worked for.

Has your Registrar given you any reason why they do notwant your QM to be over 10 pages? They can't tell you that it has to be10 pages or under, that is your call.

[compliance]

Originally Posted by Aaron Lupo

Compliance,

Here isa basic exampl of a flow chart that I put in the QM for the last company I worked for.

Has your Registrar given you any reason why they do notwant your QM to be over 10 pages? They can't tell you that it has to be10 pages or under, that is your call.

Thanks for your input. I really appreciate it. Our registrar is not mandating the 10 page limit, of course, but they strongly suggest it. The reason is that they do not want to see their customers simply regurgitate the regs. They want their customers to really think about and define the "processes" in the manual such that it includes what is most applicable to the organization.

[Viki N.]

Hi Compliance,

I have attached a sample of what we currently use for a process map (at least I hope I did it right...1st time ) It was done in Visio, but I converted to .pdf for convenience in opening.



At our last surveillance audit (ISO 13488:1996), our registrar wrote a minor AR saying that the interaction of product development processes was not defined. We had originally started the process with sales and the PO. He wanted us to start with the quoting and include the handoff to Engineering. Note: We do not do design at my company, but do develop the mfg. process.

As far as a QM, I've never heard yet that it should be kept that short, but it was suggested to us that if one of our procedures states something, try not restate it in the QM or another procedure as it gives more room for error when having to update. Our manual happens to be 22 pgs.

Hope this helps somewhat.
Viki