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ISO 13485 Audit Finding on Regulatory Issues - Internal Audits
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ISO 13485 Audit Finding on Regulatory Issues - Internal Audits
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audit nonconformances and findings, certification audits, certifications (to a standard), cmdcas certification, internal audits, iso 13485 - medical device qms, mdd (medical device directive), registration audits, registration to a standard, tga (therapeutic goods administration)
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  Post Number #9  
Old 24th July 2011, 05:35 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,255
Re: ISO 13485 Audit Finding - Internal Audits

Quote:
In Reply to Parent Post by Jennifer Kirley View Post

Did I get that right, Sidney?
Hi Jennifer.
Yes, you got the essence of my post. But let me add: Assuring regulatory compliance via internal audits is like driving a car forward by looking at the rear view mirrors (pardon the cliche'). Internal audits are just one component of the check step in the PDCA cycle.

Compliance with regulatory regulations, just like focus on customer satisfaction and product conformity CAN ONLY be sustainably achieved if the tasks and activities necessary are EMBEDDED in the business processes of the organization. Some of the regulatory requirements any organization has to comply with are part of the QMS; So, if I internally audit my QMS thoroughly, I am ALSO checking if my organization has a system to ensure regulatory compliance or not, thus no need for a separate internal regulatory compliance audit.

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