Beginning with the abstract requirement to introduce and apply a quality management system and ending with the implementation of processes which are efficient, value-adding and usable is usually a long way. Plausible processes and intelligent gathering and controlling of information ease everyday work and provide for regulatory conformity without grooming a paper tiger. When introducing or changing a QM System it is fundamental to have access to Best Practice Methods, to understand them, amend them as needed and to convey them to the employees.
From 9001 via 13485 through to the MDR.
Establishing and maintaining a quality management system was originally based on the standard EN ISO 9001. In the Nineties these requirements were transfered to the EN ISO 13485 due to regulatory reasons and the standard was last substantially amended in 2016. In virtue of the new European Medical Device Regulation (MDR) a QM System represents an essential tool for all medical device manufacturers in order to remain competitive.