13485:2016 and AS9100C format. This manual is used internally to guide the company's employees through the various requirements of the ISO 9001: 2015, ISO 13485: 2016 and AS9100C standards that must be met and 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. ISO 13485:2016 can be applied to organizations involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, servicing or final decommissioning of a 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. Clause-by-clause explanation of ISO 13485:2016 Download a complimentary white paper (PDF) This white paper explains each clause of the ISO 13485:2016 standard, while providing guidelines on what needs to be done to meet each requirement. 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 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 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. Human Resources in ISO 13485-2016 Page 2 of 4 . Training . Skills . Experience . Physical attributes required . Ability to lift 50 pou