I had my stage 1 audit, which went well. I had a minor non conformity on the quality manual. Document 03_Quality_Manual.
The non conformity was as follows: the quality management requirements are not fully inplemented because it was not made clear in the quality manual which process apply risk based approach.
This was in reference to 4.1.2.
But the quality manual template does not reference a risk based approach. The only time in document 03 that risk is mentioned is under section 7 for product realization.