Requirements & structure What are the requirements of ISO 13485? Instead, it was determined that the most recent changes in ISO 9001:2015 were not necessary for medical devices. Although the ISO 13485:2016 standard came out after the major update of ISO 9001:2015, the ISO 13485 standard does not align with this new revision of ISO 9001. Its requirements are recognized around the world as an acceptable basis for implementing a QMS. ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS), which is published by ISO (the International Organization for Standardization). The ISO 13485:2016 standard aligns with the previous version of ISO 9001, ISO 9001:2008. See all the changes here: Infographic: What’s new in the 2016 revision of ISO 13485. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design and development requirements to many regulations, more emphasis on control of suppliers, requirements for traceability procedures, addition of complaint handling, and enhancement of product cleanliness requirements. The latest revision of ISO 13485 for ISO medical devices is from March 2016. For a good explanation on this, take a look at the article List of mandatory documents required by ISO 13485:2016.Ī survey of ISO 13485-certified companies shows that the number of companies that have implemented an ISO 13485 Quality Management System still shows a general positive trend worldwide (the drop in 2018 was mainly due to a different measurement methodology).ĭata taken from 2018 ISO Survey What is the current version of ISO 13485? Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.

Together, these define the overall scope and implementation of the Quality Management System. Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

En iso 13485 2016