In Reply to Parent Post by abchris
We currently have a quality system based on CFR part 820. What we would have to add to be complaint with ISO 13485?
Hello abchris, and welcome to the Cove!
Here is a thread that may answer your question, and a file attachment that you may find useful in determining the differences between 21 CFR Part 820 and ISO 13485:2003.
Comparison of 21 CFR 820 and ISO 13485
If this doesn't adequately meet your needs, there are other discussions in the ISO 13485 - Medical Devices forum (scroll to the bottom of this page and click on the drop-down menu for the forums) that may have more of what you're looking for.
I hope this helps.