The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others relate to the overall approach to quality management systems for device companies. Supply Chain Roles in ISO 13485-2016 Page 1 of 2 . Supply Chain Roles in ISO 13485:2016 . ISO 13485:2016, clause 4.1.1 requires the organization to document the roles it has in the medical device supply chain. In an accompanying note, the roles could include manufacturer, authorized representative, importer, or distributor. ISO certification is voluntary and conformity must be verified through a recognized, accredited agency. GenX Medical received their ISO 13485:2016 certification from an independent, accredited certification company in 2019. See below to view the official certificate. ISO 13485 2016 is an international quality management standard for medical devices. This page presents an overview of ISO 13485 2016 and provides a PDF sample of our approach. Human Resources in ISO 13485-2016 Page 2 of 4 . Training . Skills . Experience . Physical attributes required . Ability to lift 50 pounds . Not colorblind . Write a procedure that explain the method, responsibility, and authority for preparing job descriptions. In addition, ensure they are included in the document control system. Job ISO 13485:2016 Medical Devices -QMS @NSAI_Standards . Why change ISO Standards? ISO Review and Revise to support Continual Improvement and Best Practice - the HLS ISO has supported the mantra of 'Integration' for many years - the HLS. ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes. standard by International Organization for Standardization, 03/01/2016. View all product details Most Recent The publication and release of ISO 13485:2016 earlier this year is a significant movement for the medical device industry. The last major revision of this quality management system standard happened bac