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 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 The ISO 13485:2016 Internal Audit Checklist This checklist is based on the information provided in the 2016-03-01 release of the ISO 13485:2016 international standard. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard. 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. 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 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 new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. 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 back in 2003. Why is this new version of