ISO 13485:2016 Medical Devices Quality Management Systems
Safety and quality are non-negotiable in the medical devices industry because service lapse could impact human lives. In this regard, ISO 13485 establishes requirements for comprehensive quality management for the design and manufacturing of medical devices. It is a stand-alone QMS standard accepted as for ISO 9000 quality management standard series. It adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.
The standard is more prescriptive in nature and requires a more thoroughly documented quality management system.