ISO 13485 & 21 CFR 820 Internal Auditing Checklist

Hello,

I am new to the forum and new to the world of Quality, so please bear with me!

I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

We've recently been audited and one finding was that the document we are using as a checklist/assessment tool does not cover ISO 13485, IVDD and FDA requriements (and we are subject to all of these). While stumbling around the Internet looking for help I came across this:
ISO 13485 and FDA QSR (21 CFR 820) INTERNAL AUDIT CHECKLIST. (I'd put the link in, but I haven't posted enough yet to do this).

From the sample pages it looks great, with the right questions that will help me, as a novice, look for the right things during an audit, as well as be prepared for what external auditors will look for. However, I wanted to see if anyone had used it and their opinion, before paying for it. My company is small and low on the $$, and this will probably come out of my own pocket if I get it.

Thanks in advance for your help!

Here is one that I found in a post using the Post Attachments List Search in the upper left corner of every forum page: ISO 13485 Practical Audit Checklist

In the forum, files are 'Post Attachments'. At the top of every forum page on the left side of the page there is a Post Attachments Listing button. Use it to get to the files listing which has a Search box in it.



This may help you.

Thanks, I read this thread and looked at the attached documents, but they looked either too process-oriented or too broad (I think right now our company and those who will be auditing, including myself, need a little more direction). That's why the one I'm asking about looked so appealing.
One of our auditors shared the checklist they use with me, but it was 80 pages long! That seemed like a bit much.

fishstix said:

Thanks, I read this thread and looked at the attached documents, but they looked either too process-oriented or too broad (I think right now our company and those who will be auditing, including myself, need a little more direction). That's why the one I'm asking about looked so appealing.
One of our auditors shared the checklist they use with me, but it was 80 pages long! That seemed like a bit much.

Click to expand...

Process oriented is the way everything is going. Well, if you want to spend the money, in my opinion than go ahead.

I can't remember which one I used, but I did find a good template from our Post Attachments List when I decided to revise our checklist. We, too, must comply with both ISO 13485 and 21 CFR 820, and the checklist I came up with (with the help of the one I found in the link at the upper left of this page) is satisfactory for our needs and our ISO auditors didn't have a problem with it, either. Just a little tweaking and changing of a few things and it works well for us.

Why spend the extra $$ if you don't need to? But, it is your decision....

fishstix said:

Hello,

I am new to the forum and new to the world of Quality, so please bear with me!

I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed. <snip>

Click to expand...

this is a check list that I found on this forum awhile ago (does not cover 820 requirements). It might still be here.

Thanks to all of you for your input! And thanks for the checklist. It's still here and perhaps I can tweak it so that it covers 820 too. I appreciate the help!

Kales Veggie said:

this is a check list that I found on this forum awhile ago (does not cover 820 requirements). It might still be here.

Click to expand...

I posted that checklist a couple of years ago. I've got a version that has added the Canadian CMDCAS requirements as well, but I've never done a version with the 21 CFR 820 requirements. Maybe someday...

You can probably add the 820 requirements to the checklist similar to the CMDCAS in this one. If you do update it, please post it here.

Thank you! If I do update the checklist, I will be sure to post it.

It's taken me a couple of weeks, but I've finished at least a first try at updating howste's checklist with 21CFR 820 requirements. It's not perfect, but I thought I would post it anyway. I've removed a few items about sterilization, as they don't apply to my company. I was hoping to do more color coding, but I ran out of steam.

If anyone finds anything truly amiss, I would love to know.

As I'm new to the site, if there's any place I should post this, please let me know.

Thanks!