ISO 13485

The wait is over !!  ISO 13485:2016 has been published. Are you ready to change your Quality Management System?. 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, the requirements for control of subcontractors has been enhanced within ISO 13485:2016. To get detailed information about the latest version please feel free to contact us and make an appointment for a gap analysis of your current quality management system.

With ISO 13485:2016 Medical device manufacturers can achieve;

  • Compliance with regulatory and legal requirements
  • Ensure that their quality management systems enables 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 changing EU medical device directives and other international regulatory changes which occurred since the second revision of the standard. (ISO 13485:2003)

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 form European Union to Canada, from Taiwan to South America have adopted the standard into their regulation.

ISO 13485, has 8 main requirements, where the requirements 4 to 8,

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

include particularly the application 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).

For more information about the application of ISO 13485: 2016 to your QMS, you can contact us at