ISO 13485

To increase the product safety and overcome problems observed in the sector within recent years ISO 13485 has been revised by the ISO Committee. This 3rd revision enhances in particular requirements for validation, risk management, compliance with legal requirements, which are very important for medical device safety. Parallel to the changes within the medical device sector, some other requirements such as control of subcontractors have been enhanced within ISO 13485: 2016.

With ISO 13485:2016 Medical device manufacturers can achieve;

  • Compliance with regulatory and legal requirements
  • Ensure that their quality management systems enable safe and effective medical devices
  • Work with a solid risk management process
  • Improve processes and efficiencies
  • Gain a competitive advantage within the market

This revision of the standard provides a basis for the quality management system in parallel to the EU MDR’s and other international regulatory changes which occurred since the second revision of the standard. (ISO 13485:2003). On the other hand the current revision has brought the quality management system requirements closer to the US FDA expectations.

ISO 13485 with the terms “quality management system” and “regulatory purposes” within its name clearly aims manufacturers to help by meeting the legal requirements of the country they intend to market their products, whereas its primary goal is patient and product safety. Many regulatory bodies have adopted the standard into their regulation.

The 3rd revision of ISO 13485 maintained the basic structure with 8 main clauses. The clauses 4 to 8 which can be summarised as;

  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product/Service Realization
  • Measurement Analysis and Improvement

include in particular the requirements for quality management systems. Unlike other management systems develop by ISO recently, ISO 13485:2016 is not in line with the new High Level Structure (HLS).