ISO 9001:2015 Clause 8.3 (Process Design not Product Design)

We exclude Clause 8.3 in our QM and Scope however we do have a Quality Procedure titled: 830 Process Design and Development. (written for process design not product design)

During our last audit the auditor recommended removing this procedure from our ‘QP’ section or renaming it. We would like to keep this procedure as it is.

Has anyone else had this issue and if so how was it resolved.

1 Replies
Janet Lentz
90 Posts

Not that exact one, but know that your registrar’s opinion on what you should name procedures is just that - an opinion. He/she is trying to make his/her job easier. I would politely decline and explain it works well for you as it is.