When is a Lead Auditor Required in a Medical Device Company?

S

Sue789

Involved In Discussions
Hi All,
Is there any requirement to employ a trained Lead Auditor in a medical device company?
I am aware you do not require Lead Auditor training to be an internal auditor only 2 days of internal audit training.
Is it a requirement for Supplier audits (2nd party audits) and if so where is it specified e.g. standard, directive (93/42?EC)?
Not interested in 3rd party audits
Thanks for your help in advance.
 
A

AndyN

Moved On
Hello Sue:

None whatsoever. It's appropriate to have competent auditors - how you have them obtain and demonstrate competency can be done (somewhat) through attendance at a training course, however, that's really just the start for many. Just like going through a BSM driving class doesn't make you a competent driver, only gets you through the driver's test, really.
 
S

Sue789

Involved In Discussions
Hi Andy,

That is the conclusion I came to after searching. I needed confirmation for my CEO.

Totally agree we learn how to take the driving test and not how to be a good driver then we have to put it into practice and that takes years just like auditing.

I have been a Lead Auditor for several years and the small medical device company I am helping wanted to know if there were any requirements. As you agree with me I will suggest internal auditor training only.

Thanks,
Sue
 
Ajit Basrur

Ajit Basrur

Leader
Admin
Sue789 said:
Hi Andy,

That is the conclusion I came to after searching. I needed confirmation for my CEO.

Totally agree we learn how to take the driving test and not how to be a good driver then we have to put it into practice and that takes years just like auditing.

I have been a Lead Auditor for several years and the small medical device company I am helping wanted to know if there were any requirements. As you agree with me I will suggest internal auditor training only.

Thanks,
Sue
Click to expand...

Yes, an Internal Auditor training will suffice and there is no requirement for a Lead Auditor training.
 
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