ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training

bme007

Starting to get Involved
The first post made it seem like the quality manager was auditing all systems. However, after my comment, the OP clarified that the lead auditor was not auditing her own work. I would redact, but I can't edit that post.
Yes. it looks that way. Here is first post "One of these forms was our final audit report, which compiles the information from all of the internal audits performed for the month to share with management. At the top of the report she labeled herself as "Lead Auditor".
I did not read any further clarification from the writer...
 
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bme007

Starting to get Involved
Help me with a clear picture here. If the regulation states "Auditors shall not audit their own work". Does it
1. Apply to all ISO standards?
2. Imply that a person can not audit all the works/processes that are in his role (job responsibility)? Must be some one else?
Thanks,
 

Sidney Vianna

Post Responsibly
Leader
Admin
Help me with a clear picture here. If the regulation states "Auditors shall not audit their own work". Does it
1. Apply to all ISO standards?
2. Imply that a person can not audit all the works/processes that are in his role (job responsibility)? Must be some one else?
Thanks,
Peruse the insightful discussion at Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) and come back to let us know your own conclusion. :naughty:
 
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