We have been asked by our NB to provide evidence that a supplier of a material of animal origin was audited against the requirements of ISO 22442 Medical devices utilizing animal tissues and their derivatives. We have completed the inactivation studies covered in ISO 22442-3, but have not formally audited the supplier against the other elements in the standard. Does anyone have or know where I can find an exisiting checklist that can be used to perform the audit?

Thank you.

I didn't see a 22442 checklist when I did a search in the Post Attachments List - see the green button in the header - but maybe you can adapt one of the checklists in there to suit you.

In addition, I will repeat my typical advice to a supplier audit checklist question. I don't like canned checklists. You can ask the basics just by jotting down the elements and putting a blank underneath them to record the evidence from your audit. But I would take this opportunity to ask about any quality issues or customer service concerns you have. If there has been a corrective action request, I would ask to see evidence of how that was managed. I would ask to see management review records to determine how, and how well, the QMS needs are resourced. Things like that which show the QMS is actually functioning.

I hope this helps!