ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based

Marc · Feb 7, 2011

Re: ISO 13485 Practical Audit Checklist

mjmendez1 said:
Are you still looking for this?

If you have a check list you want to share here I'm sure people would appreciate it, if that's what you're asking.

mjmendez1 · Feb 7, 2011

Re: ISO 13485 Practical Audit Checklist

What I did is simply take the form that the auditor used which was for MDD Annex II and 13485 and adapted it for our use. Pretty simple.

Marc · Jun 13, 2016

Re: ISO 13485 Practical Audit Checklist

This discussion was from 2003 or there abouts.

What has changed since then, particularly with ISO 13485:2003 and MDD 93/42/EEC?

lhasty474 · Feb 6, 2019

Hi, My company is starting to do their own Internal Auditing for ISO 13485:2016 and ISO 9001:2015.
I need to come up with an Internal Audit Checklist. Does anyone have a copy I can use.

AndyN · Feb 6, 2019

lhasty474 said:
Hi, My company is starting to do their own Internal Auditing for ISO 13485:2016 and ISO 9001:2015.
I need to come up with an Internal Audit Checklist. Does anyone have a copy I can use.

Ihasty474 - typically, internal audits are conducted on YOUR QMS, so someone else's checklist isn't going to be much use! Find a form here and put your own criteria on that to ask about.

lhasty474 · Feb 6, 2019

I know, I just wanted to see a template

AndyN · Feb 6, 2019

If you check the "Post attachments" and do a search there, you'll have a few to choose from.

ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based

Marc

Fully vaccinated are you?

mjmendez1

Marc

Fully vaccinated are you?

lhasty474

AndyN

Moved On

lhasty474

AndyN

Moved On

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