ISO 13485 Internal Audit Schedule example needed

L

Lou Beck

#1
Hi Al,

I am developing audit tools for my company. Your checklists look very professional. Do you have an audit schedule you can share? We are a medical device manufacturer complying with 13485:2003, MDD Annex II, QSR and MDR SOR/92-282. The current schedule used here is hard to navigate and needs to be updated. Any help would be appreciated.
 
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#2
Re: Simple effective internal audit ISO 13485 audit check list needed

Hi Al,

I am developing audit tools for my company. Your checklists look very professional. Do you have an audit schedule you can share? We are a medical device manufacturer complying with 13485:2003, MDD Annex II, QSR and MDR SOR/92-282. The current schedule used here is hard to navigate and needs to be updated. Any help would be appreciated.
I'm sure you'll see this is a very old thread. In actuality, no-one can give you an audit schedule that won't need major surgery, so why not start from scratch or take what you've got and work on that? A whole 12 month calendar isn't actually required, so you might want to revisit your understanding of how an audit program has to be established and planned. Try this for starters.. http://www.nqa-usa.com/resources/articles_detail?id=48
 
L

Lou Beck

#3
Re: Simple effective internal audit ISO 13485 audit check list needed

Andy,

All you have provided I am all ready aware of...thanks anayway.
 
L

Lou Beck

#5
Re: Simple effective internal audit ISO 13485 audit check list needed

I guess if you have to ask you really missed the point. I was looking for examples not attitude.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: Simple effective internal audit ISO 13485 audit check list needed

Lou,

I think Jan was a bit off in his comment, but it comes from a number of threads here where some people do not like "canned" check lists and some people do. Personally I don't have a problem with them. If they are made up and used correctly I see no problem with them. this is the same in many areas. I used to do implementations to various standards. My way of implementing a QMS standard is well known. Others have said it's a terrible approach. We each have our own ideas on how some things should be done.

There are some ISO 13485 check lists here such as: ISO 13485 & 21 CFR 820 Internal Auditing Checklist.

This is an old thread, but see: ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based.

Here is a quick search for ISO 13485 related Audit Checklists and discussions here: ISO 13485 Internal Audits.

There are also these files, one of which may serve your purpose: ISO 13485 related files.
 
#7
Re: Simple Effective Internal Audit ISO 13485 Audit Check List needed

The idea of a canned audit schedule is a little different to checklists. If you think about an audit schedule, it's going to be based on your QMS, not someone else's. So processes are going to be called differently. Furthermore, the 'status and importance' of your processes are going to be different again to anyone else's. Don't forget that you can't get away with auditing against a schedule of ISO 13485 elements, anymore.

Marc is correct about checklists, but audit schedules can't be 'canned' with any chance they will be any use - except to fool a poor CB auditor. Hence my comments. I'd be interested to get your feedback if, having read the article, you are still looking for a canned audit schedule. They aren't that difficult to construct, frankly, unlike a comprehensive audit checklist which IS a lot of work.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#8
Unfortunately the thread this was from posts added to an old thread the title of which did not accurately reflect the poster's request/need. I should have split this off the old thread sooner.

As to an audit schedule - If anyone has an example to share it will be appreciated.

Noted is Andy's response which is essentially correct. However, as we all know very few canned documents will be of much value other than as a reference and "food for thought". That is the essence of documents which are shared here. None are meant to fit any specific company. "Canned" documents (examples of documents) are of value to show how something can be done, to give a person ideas on formats, and other aspects.

I do apologise that this became a somewhat contentious thread quickly. It does happen from time to time on most, if not all, internet forums. We do try to monitor for problems here but are not always successful at "nipping things in the bud".
 

Jim Wynne

Staff member
Admin
#9
I am developing audit tools for my company. Your checklists look very professional. Do you have an audit schedule you can share? We are a medical device manufacturer complying with 13485:2003, MDD Annex II, QSR and MDR SOR/92-282. The current schedule used here is hard to navigate and needs to be updated. Any help would be appreciated.
What is it about your current schedule that makes it difficult to use? An audit schedule should be a fairly simple thing to compose; all you need is a list of the QMS processes and when each one is targeted to be audited. You don't even have to be specific as to dates--you can just say that process "A" is to be audited in June, "B" and "C" in July, and so on.

Tell us more about what makes your schedule difficult and we can provide better advice.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Any help would be appreciated.
Not exactly what you are looking for, but one of the best tools I have seen here, used to adjust an internal audit schedule was the one developed by Patricia Ravanello, and called the Worksheet to justify your audit plan. You might also peruse the thread where the worksheet is available at: Creating an internal audit schedule.

In your case, being subjected to the Medical Devices Regulatory Agencies scrutiny, I would pay a lot of attention to alleged product failures and the outcome of the risk management process you are expected to have in place to target some high risk processes, functions and areas for more frequent internal audits.
 
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