ISO 13485:2016

ISO 13485:2016 -

ISO 13485 states the international standard requirements for a QMS specifically aimed for medical devices. The basic requirements of ISO 9001 & ISO 13485 as ISO 13485 is based on the requirements of ISO 9001 so Just like  other standards, ISO 13485 includes the entire ISO 9001 standard with additional requirements (for medical devices) included in blue italics text.

ISO 13485 is also  required for regulatory purposes as well as non-statutory requirements for a quality management system that sets one  the major distinction of   ISO 13485 from its parent standard  9001.ISO 13485:2016 is the latest, and most current version of ISO 13485 series. This standard specifies requirements for a quality management system (QMS) centered around the medical device system, focusing on the needs of customers and applicable regulatory requirements.

ISO 13485 applies to all the suppliers and external parties that are involved in the different stages of medical device life cycle starting from from design and development to distribution and servicing, and this standard is developed to be used in organizations no matter what their role in the life-cycle.