Sorry for hanging on it, but I would like to understand and actually I have a more or less similar situation.
When you wrote the QMS, how can you be sure that you can identify your own mistakes in the course of the internal audit?
I understand you can audit the implementation of the QMS (real life follows or not the SOPs, however I would raise question of the effectiveness on the implementation, anyway its a completely different subject, sorry), I am okay with that.
Thank you
Sz.