I'm wondering if anyone else has had this happen. During a supplier audit (which is not a full QMS audit), while interviewing and reviewing records for an element of the Standard (ISO 13485, in this case) that is part of the audit scope, you discover a nonconformance of an element that is NOT part of the audit scope. Do you write this as a nonconformance or, since that element was not part of the audit scope, do you write it as an opportunity for improvement (observation)?
I would love to hear your experiences....
I would love to hear your experiences....