Our customers require high quality standards in order to be able to maintain their own Quality Management Systems and to fulfil regulatory requirements. Inpakomed bv implements and maintains a Quality Management System in compliance with the ISO 13485:2012 normative and is controlled by an independent party on a regular (yearly) basis. The requirements which must be fulfilled are quite broad and they do not solely concern technical issues but also, for instance, personnel.
Just to mention an example, a prerequisite for all employees is that they be regularly trained in order to reduce the risks of errors during the various packaging activities, to suit most customers’ requirements. The machines which are operated in the clean room are “state-of-the-art” and have been completely adapted for use in a controlled environment area.