01. September 2020

The MDSAP Council published the new "Audit Approach": MDSAP AU P0002.005. This document is combining the previous "Audit Model" and the "Companion Document" into a single source. At the same time the new "audit approach" replaces the previous documents latest 2020-09-30. It is important to notice that the text of the "audit tasks" and "criteria" have not been changed. The new document now includes 2 new annexes with further information concerning the national legislation of the member...

27. August 2018

A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization....

03. July 2018

The revised "Guidelines for Auditing Management Systems" is intended "to lift the audit to a higher level" and is not only addressing the auditors....