The International Organization for Standardization (ISO) published the updated ISO 13485 medical devices quality management systems standard on March 1, 2016.

ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. Organizations seeking certification may be involved in any portion of the medical device product lifecycle, which includes design and development, production, storage and distribution, installation, or servicing of a medical device or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, materials or service, including quality management system-related services to such organizations.

NSF International Strategic Registrations (NSF-ISR) will be working to ensure a smooth transition to the new international standard for medical device quality management systems. We are committed to developing useful tools, webinars and publications to assist your organization with the transition process. Similar publications were produced by NSF-ISR for the ISO 9001:2015 transition and can be viewed on our ISO 9001 webpage.

Key improvements in the 2016 version include:

  • Expansion of the standard’s applicability to include all organizations involved in the lifecycle of the product, from inception to end of life
  • Greater focus on post-market surveillance (including complaint handling)
  • Improved alignment with regulatory requirements
  • Increased focus on risk management
  • More emphasis on implementing the appropriate infrastructure, particularly for the production of sterile medical devices

There will be a 3-year period for current NSF-ISR clients registered to ISO 13485:2003 to transition to the 2016 version of the standard. NSF-ISR will be working with ANAB to determine the transition requirements in order to provide your organization with detailed information relating to the new version of the standard and how to best create a positive, seamless transition experience to ISO 13485:2016.

The updated standard can be purchased through the NSF Bookstore

For more information, please email NSF-ISR at information@nsf-isr.org and check our website, www.nsf-isr.org, for regular updates about the standard, including webinars, transition guides and more.