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MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
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MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback
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  Post Number #33  
Old 11th October 2017, 02:57 AM
Highground

 
 
Total Posts: 30
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

It's because we dropped ISO 9001 certification. The auditor said we needed to remove the statement and replace with the commitment to comply. Sorry... it has been a bit confusing with all the changes.

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  Post Number #34  
Old 11th October 2017, 08:05 PM
Mark Meer

 
 
Total Posts: 667
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Quote:
In Reply to Parent Post by Highground View Post

It's because we dropped ISO 9001 certification. The auditor said we needed to remove the statement and replace with the commitment to comply.
While it is true that ISO 13485:2016 includes an explicit requirement that the quality policy "includes a commitment to comply", in my opinion the auditor has no business mandating that you must remove a statement of continuous improvement.

If improvement is still applicable to your organization, then why can't it continue to be a part of your quality policy?
Thanks to Mark Meer for your informative Post and/or Attachment!
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  Post Number #35  
Old 11th October 2017, 08:34 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,946
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Quote:
In Reply to Parent Post by Mark Meer View Post

If improvement is still applicable to your organization, then why can't it continue to be a part of your quality policy?
I agree. Standards, by definition, provide minimum requirements. Anything above and beyond the minimum requirements are up to the organization.

Unless the auditor could pinpoint evidence that shows a continuous improvement drive led to product regulatory noncompliance, s/he should not reach a conclusion that it is not appropriate for a medical device manufacturer to continuously improve. Especially because, irrespective of being in a policy statement or not, most organizations interested in thriving know that, failure to improve will lead to demise.

Seems to be a case of an auditorsaurus failing to think.
  Post Number #36  
Old 13th October 2017, 08:13 AM
Highground

 
 
Total Posts: 30
Re: MDSAP (Medical Device Single Audit Program) Pilot: Please share your feedback

Quote:
In Reply to Parent Post by Mark Meer View Post

While it is true that ISO 13485:2016 includes an explicit requirement that the quality policy "includes a commitment to comply", in my opinion the auditor has no business mandating that you must remove a statement of continuous improvement.

If improvement is still applicable to your organization, then why can't it continue to be a part of your quality policy?
This was the NCR: :/

Clause...ISO13485:2016 section 5.3 Quality Policy
Requirement: Top management shall ensure that the quality policy includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system

Finding and evidence:
Management Process – Quality Policy
The current quality policy states “Continuous improvement” (i.e. related to ISO 9001), and does not state a “commitment to comply with requirements and to maintain the effectiveness of the quality management system”
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