I am currently backed into a corner, or run into a dead end, or any other overused metaphor out there.
I am trying to combine and implement the AS9100C requirements into my current quality system, which address ISO9001:2008, ISO13485, 21CFR820, and a few additional customer quality requirements.
When I initially setup my ISO9001 system, I had the 'help' of a consultant. Looking out at the information available regarding ISO9001, there is a TON of information and books. When I added the ISO13485 to my system, the amount of available information was greatly reduced, but the ISO14969 spec really helped to explain what was meant in ISO13485.
Now I am at AS9100C's doorstep, and I am hardly finding any information. By that I mean 1) books - nothing available and the two I have for the Rev B spec were basically worthless even by Rev B standards. 2) Magazine articles - Yes, they go over the Rev C highlights but not in any detail to understand what the AS9100C spec truly requires. 3) It looks like there are no industry guideline specs similar to ISO14969 for medical devices. I've seen references to ISO10006 and ISO10007 but they all seemed directed to developing major operations or towards large companies.
I've tried to do a Gap Analysis but I can't analyze that which I don't understand. I've done a lot of searching here at the Cove, which has helped some, but I still have a lot of questions to go with a lot of confusion. I do want to understand what the requirements are versus buying pre-packaged procedures. (I've already been down that road before.) There seems to be more complexity with AS9100 requirements than there was with ISO13485. By that, I mean the additional AS9100 requirements above and beyond ISO9001.
I've been told to implement AS9100 by upper management (most of us have heard that one before) and I've also been told no funds are available for a consultant.
Am I just whining? Maybe but I guess I am looking for words of wisdom or a finger pointing me in a direction somewhere.
