ISO 13485:21016
Medial Devices & Quality Management System
ISO 13485 is a stand-alone QMS standard developed from the ISO 9000 quality management standard series, which is worldwide recognised and approved. ISO 13485 is a regulated medical device manufacturing environment that adopts the ISO 9000 process-based paradigm. ISO 13485 is a regulatory compliance standard that is based on the ISO 9001 process model ideas of Plan, Do, Check, and Act. As a result, it is more prescriptive in character and necessitates a well-documented quality management system. The ISO 13485 standard was created to assist medical device manufacturers in developing quality management systems that ensure the efficiency of their processes.
Advantages :
- With accreditation, you may get access to additional markets across the world
- Outline how you'll evaluate and improve procedures across your company
- Boost efficiency, save expenses, and keep track of supply chain performance
- Demonstrate that your medical equipment are safer and more effective
- Comply with all regulatory obligations as well as consumer expectations