Simple Effective Internal Audit ISO 13485 Audit Check List needed

H

Harmonie - 2009

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
 
G

Gert Sorensen

Re: 13485 audit check list

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.
 
H

Harmonie - 2009

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.
 
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