AS9101 Rev F - Worksheets for internal auditing

G

GSimpson

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#1
#1
We are moving up to revision F from D and I need to revise worksheets for internal auditing. Can anyone give me some guidance as to a source of information or templates available to update my internal audit worksheets?
Thanks in advance,
Gary
 
QMS for Medical Device Companies
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Sidney Vianna

Sidney Vianna

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#2
#2
Not sure if you mean AS9100 or AS9101. AS9100 is in Rev. D, not F. AS9101 is in Rev. F, but it applies to CB's and their auditors.

The AS9101 support forms are available from the IAQG website via this link.
 
A

AndyN

Moved On
#3
#3
GSimpson said:
We are moving up to revision F from D and I need to revise worksheets for internal auditing. Can anyone give me some guidance as to a source of information or templates available to update my internal audit worksheets?
Thanks in advance,
Gary
Click to expand...
I agree with Sidney. For internal auditing you shouldn't be using anything the CBs use for their audits. It's a bureaucracy, apart from anything else. Internal auditors should use an effective tool suitable for internal audits - which uses the "KISS" principle.
 
A

AndyN

Moved On
#5
#5
GSimpson said:
So, what you are saying is, " What I have done in the past is sufficient for the new Rev as long as it meets the Req. of our QMS"?
Click to expand...
Basically. Your internal audits should focus on your processes. So in planning, your auditor(s) should take a look at the documented process and the support process(es) which control and enable that process. Audits should - for the most part - be of the process.
 
C

Charks

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#8
#8
Can anyone tell me if they have done away with the OER?
Last one was Appendix A
What do they have to go with AS9101F
Thanks for any help
Char
 
Sidney Vianna

Sidney Vianna

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#9
#9
Charks said:
What do they have to go with AS9101F
Click to expand...
9101F Form 1 - Stage 1 Audit Report
9101F Form 2 - QMS Process Matrix Report
9101F Form 3 - Process Effectiveness Assessment Report
9101F Form 4 - Nonconformity Report (NCR)
9101F Form 5 - Audit Report
9101F Form 6 - Supplemental Audit Report

Link provided in post # 2 of this thread.

By the way, those forms are MEANT to be used by CB's, not internal auditors. Actually attempting to use tools developed for external audit purposes in internal audits might be significantly counterproductive.
 
C

Charks

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#10
#10
Hi.,
Thank you I did check out the links but I am not seeing the OER, I use that for guidance in our Internal Auditing Work Instructions for guidance to the internal auditors.
 
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