The international standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance with regulatory requirements.

The standard supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose. The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.

The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers. By using ISO 13485, organizations will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients.

What are the main changes?

  • Definitions such as the manufacturer, distributor and importer are clarified so it is more clear who is considered by the regulations as the legal manufacturer;
  • Risk management and decision-making where not only basic risk applies to the design and development, but to all aspects of the quality management. The term risk is added to the standard’s requirements about 30 times;
  • Additional requirements, and clarity with regard to verification, validation and design activities; including the addition of transfer of the design as a design activity (section 7.3.8) and the synergy with the FDA Device Master Record (DMR) as indicated in section 4.2.3;
  • Strengthening of supplier control processes;
  • Increased focus regarding feedback mechanisms;
  • More explicit requirements for software validation for different applications.

ISO 13485 is not aligned with the High Level Structure (HLS) as we know it from the new ISO 9001:2015. Manufacturers of medical devices that are certified to both ISO 13485 and ISO 9001:2015 will need to be aware of the difference in structure.

What does this mean for your existing ISO 13485 certificate?

The transitional period starts in February 2016 and ends in February 2019. After February 2019, certificates based on ISO 13485:2003/ 2012 will no longer be valid. Between February 2016 and February 2018, an organization may choose to obtain a new certificate based on the old version of the standard. However, the validity of such a certificate expires in February 2019.


Would you like to know more about the new ISO 13485:2016 standard? Please contact us by phone at +31 (0)72-3030310 or send an email to: nl.office@qms-cert.com.