So we have products that change frequently, bacteria and viruses, and since we are updating our quality system to the new 2016 ISO 13485 standard, we are having issues trying to figure out what to do with them and still be compliant. Does anyone have any experience with this? What do you do? We used to use deviations explaining custom records did not have to comply with certain aspects but now that we've amped up out nonconforming material procedure, it's making it a bit harder to justify not filing hundreds and hundreds of NCM reports for what once used just a couple deviation reports. Obviously, manufacturing is not happy about hundreds of reports that they don't have time to fill out. What do we do? Can we somehow exempt custom records from our quality manual/system?
Insert rock, me and a hard place. Thank you!
Insert rock, me and a hard place. Thank you!