Module 17 2024

05/12/2024

Unannounced Audits

Presented by:Kevin Butcher: Principal Regulatory Consultant - NAMSA

Date: 5 th December 2024

The Organisation for Professionals in Regulatory Affairs

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Subject of Lecture

The title of this lecture on the agenda is “Unannounced Audits & ISO13485”.

This subject was originally agreed upon in 2016, the year that the ISO13485 standard was updated. However, it has now been eight years since the change to ISO13485. As Unannounced Audits are not QMS audits and there is no relationship between Unannounced Audits and ISO13485, it has been decided to change this lecture to only cover unannounced audits.

However, if anyone has any specific questions they would like to discuss concerning ISO13485, we can cover these at the end of the session

The Organisation for Professionals in Regulatory Affairs

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