Looking for ISO 13485 Internal Audit Checklist

Jim Wynne

Leader
Admin
Welcome to the Cove. :bigwave: You can check the attachment list at the top of the page. You should be aware, however, that internal audits might cover many different processes and there won't be a single checklist that's likely to be useful to you. If you're going to use checklists, it's best to develop them yourself for your own processes.
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
Hi Could you provide the internal Auditor check list for 13485:2016

The standard contains the framework for your checklist. Each requirement in the standard can be a component of an audit checklist.

However, with process-based auditing, checklists that add value are often unique to each organization as they blend the requirements from both the standard and the organization's own processes.
 

Hi_Its_Matt

Involved In Discussions
Generating your own checklist in advance of and in preparation for an internal audit (assuming you are the auditor) can be one of the best methods to actually prepare for the audit. Primarily, it will help you plan the audit and it will refresh you on what the actual requirements (of the standards and your own internal processes) are. It should help you think logically through your processes, their interactions, and the best order to review them, and will help ensure that you hit on all the relevant topics. It should also help you think critically about where the risks (operational, safety, compliance, or otherwise) are.

Maybe some people can get all that just by reviewing something someone else put together, but I personally learn/refresh best by writing things down for myself.

So all that goes to say that even if you do find an off-the-shelf internal audit checklist, I would highly encourage you to generate your own.
 

donna0816

Quality Systems Manager
Hi Could you provide the internal Auditor check list for 13485:2016
Hello, I am also looking for an ISO 13485 checklist for use in a supplier audit, any luck? I didn't want to recreate the wheel. I am Lead Auditor certified, but the company i work for isn't, so i can't get one from an accredited firm.
 

Swimming In The Soup

Involved In Discussions
Hello, I am also looking for an ISO 13485 checklist for use in a supplier audit, any luck? I didn't want to recreate the wheel. I am Lead Auditor certified, but the company i work for isn't, so i can't get one from an accredited firm.

I agree with the previous replies that the checklist should reflect the area of audit. Given that, I had relied on people getting my document base started and it is time to pay it forward. I acquired this free checklist from Greenlight Guru through one of their download links and I claim no rights to it. Of course all of the rights belong to Greenlight Guru and the document should not be modified without their permission.

Moderator Note: A copyrighted document was removed from this post. Posting copyrighted material in the Cove is strictly prohibited.
 
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