ISO 13485 Quality Management Systems for Medical Devices

Published in July 2003, and based on the ISO 9001:2000 process model approach, this international standard specifies the requirements for a quality management system for the design, production and installation and servicing of medical devices. The requirements are complementary to the technical requirements for products.

Benefits of ISO 13485

  • Promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale
  • Incorporates many of the ISO 9001 quality management principles
  • Helps company to achieve business excellence/improvements