ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical laboratory. ISO 15189 may be consider the analogue of ISO

The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about Design Changes and the management of change control and we

The definition of the Quality Policy of the organization is one of the essential tasks associated to the top management according to ISO 13485 and other quality management system standards

SOP - Standard Operating Procedure -  are at the basis of any quality management system, independently from the business of the organization. The can be defied as “ set

Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration one main standard: ISO 13485 - Medical devices — Quality management systems