When it was just CMDCAS and ISO13485:2016, we had an internal audit checklist. That checklist went through the ISO standard section by section, point by point and determined if our quality system addressed those requirements. After moving to the MDSAP audit style, we passed our initial audit. On our surveillance audit, the new auditor disagreed with that approach. He said that our internal audit now must follow the MDSAP audit approach, and our previous 'ISO point by point' audit wasn't valid.
I couldn't find anywhere online that agreed or disagreed with this finding. I'm limited in my ISO knowledge, but I thought that if internally we adhered to the standard, we adhered to the standard. I take it I'm wrong?
Cheers,
Mark
I couldn't find anywhere online that agreed or disagreed with this finding. I'm limited in my ISO knowledge, but I thought that if internally we adhered to the standard, we adhered to the standard. I take it I'm wrong?
Cheers,
Mark