Re: Translation SOP
Maybe this is covered in the other threads but I'll toss in my $0.02 anyway.
There are several things in play with what your auditor said.
First, you are purchasing a service; therefore, you need to qualify & approve your provider. Are they qualified to translate medical device related information; i.e., technical matters versus casual conversation. Just because a person is a native speaker of the language into which you're translating doesn't mean that the translated (technical) material is correct! Learned that one!
Second, and this may be a bit of a contentious point, I consider the translation effort to be another "design output" that requires validation. How do you know you received a valid translation?
I'm not sure why an auditor would request an SOP in particular. I do believe you need to be able to demonstrate the above, though. An SOP (or WI) providing the guidelines for doing so certainly isn't a bad idea.