You want to look closely at ISO 13485 and results of previous FDA audits. In your "product realization" and "training" sections be sure to address FDA Good Manufacturing Practices (GMP's). Look especially at their documentation dings and make sure that the quality manual addresses those areas.
The QM is essentially just a restatement of the standard's requirements. Where it says "the company shall", you say "we do..." and point to a procedure that provides more details and a roadmap to specific instructions and forms. The QM then becomes a document map for future auditors.
I'm bringing a food packaging plant into ISO/FDA compliance. It's a job!
There are consulting companies out there -- for $25,000 they will bring in a team of auditors, identify all of the compliance gaps, and leave you with a precise list of what you need to do. You have to do your homework first by writing a Quality Manual, Quality Policy, Quality Objectives, and the QMS procedures. It's also a good idea to have the company-specific procedures drafted if not completed. This might be a good investment considering that failure to comply with FDA requirements could mean going out of business.
Good luck!
Dgreen07
