Auditing Checklist for MDD 93/42/EEU that will cross reference several regulations

A

Aliveguy

#1
Hello, I am a new member of Elsmar Cove and I am trying my first Thread.
I am looking for a Robust Checklist that will cross reference several regulations that we need to audit for compliance. Specifically, the addition of the MDD 93/42/EEU ammended to 2007 M5, and the CMDR lined up with the sections for ISO 13485:2003 and ISO 9001:2008.

I have found several in the threads already, but did not find a good one that shows the needed detail that I know is out there.

Any suggestions ??:thanx:
 
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Marc

Fully vaccinated are you?
Leader
Admin
#3
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

Another quick "Bump". Anyone here who can help with this one? My Thanks in advance!
 

GStough

Leader
Super Moderator
#4
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

My checklist for regulatory audits is not in a matrix format, and because our industry is a little different, there are other regs listed on the checklist.

I'll look and see if I can find something that might be useful for you as a starting point, though. :cool:
 
A

Aliveguy

#6
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

Thanks for the starting point. We are short on Internal Auditors and I am trying to set up something that will allow us to minimize the repeated efforts of doing multiple regulatory audits. Many of the same items appear in all regulations and these are sometimes hard to connect.

Thanks again and any added help will be wonderful...:yes::yes:
 

GStough

Leader
Super Moderator
#7
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

Thanks for the starting point. We are short on Internal Auditors and I am trying to set up something that will allow us to minimize the repeated efforts of doing multiple regulatory audits. Many of the same items appear in all regulations and these are sometimes hard to connect.

Thanks again and any added help will be wonderful...:yes::yes:
You're welcome....Oh, and.....

If you find that one document which cross-references so many regs/standards to be a bit much, perhaps consider two documents (checklists) which cover all of them. For example, one document for ISO 13485 and 9001 and another one for MDD and CMDR.

Just another option to consider.

:bigwave:
 
A

Aliveguy

#8
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

You're welcome....Oh, and.....

If you find that one document which cross-references so many regs/standards to be a bit much, perhaps consider two documents (checklists) which cover all of them. For example, one document for ISO 13485 and 9001 and another one for MDD and CMDR.

Just another option to consider.

:bigwave:
Good Point !! I like the idea of Two checklists !!

Thanks again !
 
A

Aliveguy

#10
Re: Auditing Checklist for MDD 93/42/EEU that will cross reference several regulation

Hi..
See attached, which I got it from Elsmar sometime back, covering ISO 13485, MDD, CMDR and QSR and JPAL.

I hope this helps.

Regards,
Sreenu
THANKS !!!!

This is the best version I have looked at to date. Much appreciation !!

Have a great Day !!
 
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