Dear William,
Your guidance is much appreciated. As said, this internal audit is for a very small organisation which only has basic system in place. However, I understand that the regulations has to be met by large and small organisation regardless. I'm not intending to burden them with a lot of work. Implementation will have to be gradual. Therefore, I was looking for some basic checklist which can help solve two things at one go i.e. internal audit and risk management.
In regards to your suggestion on 14971:2012, this company only distributes in ANZ and not in Europe currently. Although, the TGA tends to follow the EU ways of doing things.
Thank you again for your time.
Kind regards
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Romit Singh
Regulatory Affairs Associate
Device Technologies Pty Ltd
Frenchs Forest
Australia
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Original Message:
Sent: 06-11-2013 05:34
From: William White
Subject: ISO 14971:2007 Audit Checklist
The Canadian Standards Association has an excellent publication, Plus 14971, which has questions that may be asked by a 3rd party auditor and that may be useful as internal audit questions. This publication has much more than just these questions and is an important resource for any organization wanting to implement this standard.
You will want to keep in mind in addition that the recent publication of 14971:2012, although not changing any actual requirements in the standard, emphasizes the way in which the standard must be applied in relation to products for Europe. You will probably want your internal audit questions to reflect those implications as well.
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 06-10-2013 22:23
From: Romit Singh
Subject: ISO 14971:2007 Audit Checklist
Hi Everyone,
Can someone provide me a checklist of ISO 1491:2007 audit checklist for internal audit purposes, ideally with a combination of open ended and closed ended questions?
Thanks in advance.
Kind regards
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Romit Singh
Regulatory Affairs Associate
Device Technologies Pty Ltd
Frenchs Forest
Australia
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