Re: For Reference Only or Calibration/Verification
Yes. That's why I said that the rationale for excluding devices or applications should be documented.
I agree totally. That's my point, people use the "for reference only" as a crutch not to calibrate.
In this specific case (original post), the organization may want to do a mini-FMEA, a risk analysis and then make a decision based upon that result. As an auditor, where The Standard states "where necessary" or "where applicable", if an organization states "not necessary", if they showed me their risk analysis that they signed off on, then I'd have to accept it because if they state that, my follow-up question is "what was the thought process behind that determination?"
In this specific case (original post), the organization may want to do a mini-FMEA, a risk analysis and then make a decision based upon that result. As an auditor, where The Standard states "where necessary" or "where applicable", if an organization states "not necessary", if they showed me their risk analysis that they signed off on, then I'd have to accept it because if they state that, my follow-up question is "what was the thought process behind that determination?"

