I will be an ISO 13485 Auditor soon - Your suggestions are appreciated

D

DRDDO

#1
Dear All,
On 1 Dec 2008, I will be the ISO 13485 Auditor,
This's Exciting me,
I would like to be good Medical device auditor, but how!
Your suggestions are my appreciate,
:thanks:
DRDDO
 
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Sidney Vianna

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#3
I would like to be good Medical device auditor, but how!
Having a profound knowledge of:
  • Quality Management Systems
  • Medical Device Manufacturers
  • Medical Device Regulations
  • ISO 13485
Having excellent communication skills, common sense and a good understanding of business processes. It also helps if you have a positive attitude, and, while not compromising the independence aspect of the auditor role, assist the auditee in their quest of continual improvement.
 
D

DRDDO

#8
Thanks Randy,
By the process, I will be trainee first:
Audit-Observation --> Audit undersupervision --> Audit-Team member --> Surveillance Auditor --> Team Leader...
it take so long time as you say to be competent, you know!!!!
Short-cut please,
DRDDO
 
D

DRDDO

#10
Randy
So as you said be Competent, you exactly mean I must learn from supervisors, collect experience day by day, find new audit technique and etc.
OK No short cut, what about audit technique,
Thanks
DRDDO
 
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