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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
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How to Audit Outsource process (New Trainee Auditor)

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  Post Number #1  
Old 9th December 2008, 08:56 AM
DRDDO

 
 
Total Posts: 94
Question How to Audit Outsource process (New Trainee Auditor)

Dear All,
It, DRDO the Auditor trainee.
Today I observe my supervisor audit the outsource process (Clause 4.1).
Fact is, the QA activities are completly conducted by Outsource!
Contarct is made for both other.
The evaluation report is same as other supplier evaluation report (Clause 7.4.1),
I beleve NC should be raised!
But my supervisor raise Obs!
I really need some advise to be competent auditor

DRDDO

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  Post Number #2  
Old 9th December 2008, 09:02 AM
DannyK

 
 
Total Posts: 617
Re: How to Audit Outsource process (New I be Auditor trainee)

When auditing outsourced processes, it is important to see if there is an agreement between the 2 parties and that the requirements for the activities are written and communicated to the company performing the outsourced activity.

QA activities can be outsourced as well, but final release should be within the original company.

If you feel strongly about an NC, you should discuss it with the lead auditor. It is after all, part of your training and there may be justifications for issuing observations.

You will never learn unless you ask questions.
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  Post Number #3  
Old 9th December 2008, 10:08 PM
DRDDO

 
 
Total Posts: 94
Re: How to Audit Outsource process (New Trainee Auditor)

Clear answer

DRDDO
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