Re: Creating Quality System and using it before it is complete
In Reply to Parent Post by Randy-BCEC
Fortunately, I am only a few procedures into the 25 or so I think I need. I think I will change gears, get the Document Control procedure in place, then start implementing procedures as they are approved.
It turns out that we are collecting a lot of information based on our last FDA inspection. The problem is that it is just data without a known procedure and without an overall quality system in place. A big piece of what I am doing is documenting the current processes and seeing where they fit in terms of ISO 13485. I have been able to identify a few improvements so far.
The toughest part for me is not having a crystal clear picture of what the finished system will look like. I keep getting stuck on little issues (formatting, completeness of the procedure, keeping it simple, etc...) I feel like I have a plan, but I am not sure that the work is correct.
I would suggest you to avail(invest on) the services of the folks available in the industry who can establish the Quality System by taking inputs from you.
I am sure you can find a suitable one in this forum
there is a limit for pragmatism