Quality System Manual Annexure

Dear All,

Is it necessary or advisable in general the addition of Annexes or Appendices in the Quality System Manual?

Since in the QSM, a supplement was being mentioned, is it sufficient enough?
For Example is the Master Quality Organizational Chart…
What are the sample annexes that may be included in the QSM, just in case it is necessary?

As far as I have searched, QSM is ISO based… How it is related or mentioned or required in PIC/S?

Is there a specific format mentioned?

Hope you can share your ideas soon.

Thank you very much.

The format and organization of your quality system is up to you, as long as you comply with the standards (e.g., ISO) / regulations (e.g., US FDA QSR) you are held to (caveat: there are a number of places where a statement similar to “a documented procedure shall…” is used and apparently this is always interpreted as a separate procedure; i.e,. stand-alone doc).

It’s generally helpful (both to you and auditors) to have a mapping between the standard/regulation and your Quality System. That helps show coverage and helps in organization. A simple table is typically used (column 1 is the standard reference, column 2 is where you address the standard in your quality system)