A
Ok, so I am filling in to clean up ISO13485 observations and this is the observation "No SOP was available to review describing measurement of KPI/Quality indicators". It is listed under %.4.1 Quality Objectives.
Now - we have Quality objectives listed in our manual. They are correct, there is no SOP. Do we need one? Can someone share for a rough outline? How do I get away without one?
Thanks

Now - we have Quality objectives listed in our manual. They are correct, there is no SOP. Do we need one? Can someone share for a rough outline? How do I get away without one?
Thanks

Just exploring here after having a similar discussion with an auditor. I agree the standard does not require an SOP, but could they have been looking for evidence that the objectives were reviewed during a Management Review? I had quickly written up the minutes of the MR and was not as expansive on the Quality Objective discussions as the auditor would want and got into a similar sounding discussion.