The Cove Business Standards Discussion Forums
Is it advisable to do MDSAP and ISO 13485:2016 at the same time?
Please read this thread...
Software update
Is it advisable to do MDSAP and ISO 13485:2016 at the same time?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
integrated management systems, iso 13485:2016, mdsap (medical device single audit program)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 31st October 2017, 09:32 PM
snoopy2017

 
 
Total Posts: 91
Question Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Hi everyone,

The company I work at is currently ISO 13485:2003 certified. We have not transitioned to ISO 13485:2016 yet. With MDSAP coming up, is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Step 1: Transition to 13485:2016
Step 2: MDSAP audit for 13485:2016

What kind of timeline are we looking at between now and January 2019?

Thanks.

Sponsored Links
  Post Number #2  
Old 9th December 2017, 01:00 PM
isolytical

 
 
Total Posts: 24
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

MDSAP applies to the AO, setting auditing requirements for the AO, not to the manufacturer. The manufacturer, if utilizing an MDSAP recognized AO, may contract the AO to perform an MDSAP audit.
  Post Number #3  
Old 9th December 2017, 10:59 PM
DannyK

 
 
Total Posts: 676
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

It depends on if you have medical device licenses with Canada. If you do have licenses with Canada then I would say to go ahead. If not, just upgrade to ISO 13485:2016.
Thank You to DannyK for your informative Post and/or Attachment!
  Post Number #4  
Old 11th December 2017, 03:20 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

We are in Canada and I would absolutely have done it given a chance, as it saves a ton of money and time. If in Canada, just prepare for ISO 13485:2016 and you should be ready for both HC and FDA components of MDSAP. Most 'novelties' in 2016 standard are FDA QSR requirements like preventing mix-ups (GMP), training effectiveness, Medical Device File i.e. DMR, etc.). Doing the audit first with your internal auditor before meeting the AO will help you nail down any minor wrings.

Last edited by Jane's; 11th December 2017 at 03:26 PM.
  Post Number #5  
Old 11th December 2017, 06:14 PM
Ronen E

 
 
Total Posts: 3,736
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

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

We are in Canada and I would absolutely have done it given a chance, as it saves a ton of money and time.
I agree that for orgs in Canada / selling into Canada doing 13485 & MDSAP together makes sense, because MDSAP will soon be mandatory for them. However, for other orgs adding MDSAP on top of 13485 might actually be more expensive / burdensome than 13485 + other specific domains regulatory audits.

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

If in Canada, just prepare for ISO 13485:2016 and you should be ready for both HC and FDA components of MDSAP.
I wouldn’t go as far as saying that ISO 13485:2016 compliance covers all FDA requirements, except for in the general sense that ISO 13485 requires compliance with all applicable regulatory requirements (in that general sense preparing for “just” ISO 13485 covers any and all regulatory domains the org distributes in).

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

Most 'novelties' in 2016 standard are FDA QSR requirements like preventing mix-ups (GMP), training effectiveness, Medical Device File i.e. DMR, etc.).
First, this is a strange statement to me and I would look for confirmation from people who were actually involved in creating the 2016 revision (e.g. Marcelo Antunes).

Specifically, the requirement for a medical device file was already there in the 2003 revision and it indeed resembled the DMR, in a way. The 2016 requirements under medical device file are different from DMR requirements in some clear ways.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #6  
Old 12th December 2017, 05:27 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Quote:
The 2016 requirements under medical device file are different from DMR requirements in some clear ways.
If you don't mind, could you please elaborate in what clear ways are the QSR DMR and MDF as per ISO 13485:2016 different. IIRC, they both require the same: intended use, specifications, manufacturing, labeling, packaging, monitoring, traceability, installation, and/or servicing.

Last edited by Jane's; 12th December 2017 at 05:38 PM.
  Post Number #7  
Old 12th December 2017, 05:57 PM
Ronen E

 
 
Total Posts: 3,736
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

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

If you don't mind, could you please elaborate in what clear ways are the QSR DMR and MDF as per ISO 13485:2016 different. IIRC, they both require the same: intended use, specifications, manufacturing, labeling, packaging, monitoring, traceability, installation, and/or servicing.
Medical Device File Requirements (ISO 13485 Cl. 4.2.3)
  Post Number #8  
Old 12th December 2017, 07:21 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Is it advisable to do MDSAP and ISO 13485:2016 at the same time?

Thanks for that Ronen. Might be the 3 pm slump, but the differences stated in that discussion were not clear to me. Thanks anyway, appreciate the effort.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison al40 ISO 13485:2016 - Medical Device Quality Management Systems 4 18th April 2018 11:00 AM
Does MDSAP replace ISO 13485, or do both have to be maintained? Mark Meer ISO 13485:2016 - Medical Device Quality Management Systems 25 22nd August 2017 03:59 PM
Update of SOPs for ISO 13485:2016 / MDSAP Wolf.K ISO 13485:2016 - Medical Device Quality Management Systems 28 26th May 2017 08:43 AM
Which version of ISO 13485 would be considered for MDSAP certificate? Yasuaki Canada Medical Device Regulations 8 31st March 2017 06:53 AM
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday Shamann2 ISO 13485:2016 - Medical Device Quality Management Systems 4 2nd February 2017 12:13 AM



The time now is 07:29 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"