Hello, I am needing someone to give me their opinion. I received an audit finding from our ISO 13485:2016 audit. My auditor says we need to have an FMEA for each QS process. Not just manufacturing process work instructions FMEAs. She cited 7.1 as the clause. I just do not interpret this clause in this way. Am I way off? I've been scouring the net for an article or white paper discussing this with an example severity rating table, with no luck. Ultimately, I'll probably reach out to my auditor to ask for clarification but wanted to chat with the experts first.
Thanks in advance!
Beverly Wideman, CQA