Hi,
My company still has to undergo the transition to ISO13485, 2003. This was a choice made by management earlier and at that time I agreed. I thought I was prepared but when I read the draft quality manual I had prepared earlier I found that I don't like it! I have spent some time looking around and using the search feature in an attempt to see if someone has posted a template or example of a quality manual for a medical device company but I failed to find one.
Would anyone be kind enough to share one? I am not trying to wimp out and find one to copy to get out of writing it, I need to be able to build what my company needs. I feel once I have this in place the rest of the transition should fall into place (or am I fooling myself).
Al, Thanks to your previous posts I went to Clinivation first. However I could not find what version of 13485 and other standards they had written it for. I will look at it closer.
Thanks,
Bridget
Bridget,
It appears that Clinivation's manual is aligned with FDA QSR. If it includes the additional ISO 13485 requirements (I haven't scrutinized Clinivation's files fully enought to know) then it essentially complies with ISO 13485, just not aligned the same way. If you are trying to write a manual that complies with both, then you are in for a real treat. There is no simple alignment. There was a thread here that discussed the alignment issue, but I don't recall where it is and I gotta leave right now. I'll try to find it later unless someone else beats me to it.
We had a BSI auditor do a pre-assessement and she said that our manual was just fine (aligned to FDA and ISO 13485:1996) and all we had to do was add the additional requirements and we would be ok. Needless to say, I didn't want to do that because I like the process approach better. The most important thing is to make sure that you have all the elements covered. It also helps if it makes sense to the people who have to use it.
Hi 45fan!
I also have to blend in the requirements for CMDCAS and The MDD. How easy was it to write the manual with a process approach? I have created this system where I work in 1996 with little outside exposure so the process approach is new to me and I am having difficulty finding someone to go over it with me. I have used several cove resources and found process articles and powerpoint presentations but until I can apply it to my company I feel inadequate.
Thanks for your input.
Bridget
Here is the link to Mr. Ed Kimmelman's matrix comparing ISO 13485 vs. QSR. He is an FDA Consultant and ISO/TC 210 SC1 Chairman. Originally posted by user SilverHawk to which I owe many thanks for sharing this:
As far as setting things up to the process approach, I must admit that I too have been feeling inadequate, and since I'm not done with my system, I don't really want to give too much advice on it, but I will share my system level QMS flowchart. This is patterned after an example in BSI's book "The Route to Registration" which was written for ISO 9001, not 13485, so its close enough. Of course, the system level processes get detailed with other flowcharts and processes. If its good enough for our chosen auditor, it should be good enough for us, I hope. I would appreciate feedback on this from any of you more experienced QA gurus.
I haven't read CDMCAS, but I am under the impression that it is basically 13485 with a few extra twists. MDD approach: QMS in compliance with 13485, add Essential requirements checklist, talk to distributor about any other regional or national requirements, if you are doing clinical trials, compliance with harmonized standard EN 540 "Clinical Investigation of medical devices for human subjects" equals compliance with Annex X, start planning for document translations EARLY-you need 5 languages to sell in all of EU-one is English, and of course technical files, design dossier if needed. Those are the biggies not specifically given in ISO 13485 that I can think of immediately. I'll have to review my procedures and see if I'm done with those.
Last edited by Marc; 15th September 2004 at 09:32 PM.
Seeking help with ISO13485 quality manual
Thanks to your previous posts I went to Clinivation first. However I could not find what version of 13485 and other standards they had written it for. I will look at it closer.
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