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Internal Audit Program under MDSAP and 13485:2016
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Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
Internal Audit Program under MDSAP and 13485:2016
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Internal Audit Program under MDSAP and 13485:2016


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Some Related Topic Tags
internal audits, iso 13485:2016, mdsap (medical device single audit program)
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  Post Number #1  
Old 27th November 2017, 10:56 PM
snoopy2017

 
 
Total Posts: 82
Please Help! Internal Audit Program under MDSAP and 13485:2016

Hi everyone,

Does anyone have suggestions on how we can establish an internal audit program based on both ISO 13485:2016 and MDSAP? How would this internal audit program look different from a previous program under 13485 only?

I would appreciate any advice.

Thank you.

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  Post Number #2  
Old 27th November 2017, 11:03 PM
Ronen E

 
 
Total Posts: 3,736
Re: Internal Audit Program under MDSAP and 13485:2016

Quote:
In Reply to Parent Post by snoopy2017 View Post

How would this internal audit program look different from a previous program under 13485 only?
It wouldn’t and it shouln’t. ISO 13485 is also about compliance with applicable regulatory requirements, so real ISO 13485 compliance is supposed to address regulatory compliance in all relevant jurisdictions anyway.
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #3  
Old 6th December 2017, 07:59 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Internal Audit Program under MDSAP and 13485:2016

Hello, I was wondering why would you want both, why not just MDSAP?
  Post Number #4  
Old 7th December 2017, 08:06 AM
Ronen E

 
 
Total Posts: 3,736
Re: Internal Audit Program under MDSAP and 13485:2016

Quote:
In Reply to Parent Post by Jane's View Post

Hello, I was wondering why would you want both, why not just MDSAP?
MDSAP is based on 13485. 13485 is a subset of MDSAP. In that sense, what does “just MDSAP” mean?
  Post Number #5  
Old 7th December 2017, 12:31 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Internal Audit Program under MDSAP and 13485:2016

Hi Ronen. I probably didn't formulate my question well. Since ISO 13485 compliance comes inherent with MDSAP compliance, I was confused by the OP asking about "an internal audit program based on both ISO 13485:2016 and MDSAP". If you satisfy MDSAP, you will satisfy ISO 13485, so wouldn't it be enough to have an internal audit system only based on MDSAP?
  Post Number #6  
Old 7th December 2017, 05:19 PM
Ronen E

 
 
Total Posts: 3,736
Re: Internal Audit Program under MDSAP and 13485:2016

Quote:
In Reply to Parent Post by Jane's View Post

Hi Ronen. I probably didn't formulate my question well. Since ISO 13485 compliance comes inherent with MDSAP compliance, I was confused by the OP asking about "an internal audit program based on both ISO 13485:2016 and MDSAP". If you satisfy MDSAP, you will satisfy ISO 13485, so wouldn't it be enough to have an internal audit system only based on MDSAP?
My opinion -

As I replied to the OP, MDSAP doesn’t add anything that isn’t already required by “standalone” 13485, from an internal auditing aspect, so in my mind they’d need “an internal audit system only based on 13485”. MDSAP is a shell.

But anyway, it’s just semantics. Both are the same, from that specific aspect.
  Post Number #7  
Old 7th December 2017, 05:53 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Internal Audit Program under MDSAP and 13485:2016

The difference may be that MDSAP adds regulatory requirements specific for Brazil and Japan for example, while ISO 13485 would not identify those requirements as applicable, assuming the company does not sell in Brazil or Japan.
  Post Number #8  
Old 7th December 2017, 07:55 PM
Ronen E

 
 
Total Posts: 3,736
Re: Internal Audit Program under MDSAP and 13485:2016

Quote:
In Reply to Parent Post by Jane's View Post

The difference may be that MDSAP adds regulatory requirements specific for Brazil and Japan for example, while ISO 13485 would not identify those requirements as applicable, assuming the company does not sell in Brazil or Japan.
MDSAP doesn’t require regulatory compliance in domains where the audited org doesn’t distribute.
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