Hi,

I need a simple effective internal audit check sheet to 13485. I found a couple in threads but they are a couple years old. The goal is to satisfy 13485's requirement for internal audit as it's been almost a year since last done. Since I am new, I don't have time to put our own together until next quarter and the existing one is huge. It was designed to be done department by department over a period of months.

Welcome any help. It's an emergency. Thanks in advance

Hi,

I need a simple effective internal audit check sheet to 13485. I found a couple in threads but they are a couple years old. The goal is to satisfy 13485's requirement for internal audit as it's been almost a year since last done. Since I am new, I don't have time to put our own together until next quarter and the existing one is huge. It was designed to be done department by department over a period of months.

Welcome any help. It's an emergency. Thanks in advance

Hi,

There are some checklists here in the Cove, but to be honest, if you already have a checklist for your company and it is simply to big to overcome in one audit, then divide it into sections instead. Keep in mind though, that a checklist is not a definitive list, it only makes sure that you check against the standard, it does not necessarily make sure that you check against your own procedures etc.

First identify your processes, then you can develop a checklist for each process. I've attached some draft checklists here, but they may not be appropriate to your organization. You can use them as a guide to develop your own.

Thank you! I have only been allocated two calender days to get this done. A more formal but realistic audit program will be developed later.