ISO 13485: 2003 is the internationally recognized standard for quality management systems in the medical device industry. It is a Quality System that applies to the design, development, production, installation, servicing and sales of Medical Devices.
Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place, the emphasis focuses on meeting regulatory and customer requirements, risk management and maintenance of effective processes.
This certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world.
Therefore, 13485 certification serves to create a management system that acts as a framework on which to build compliance to various regulatory and customer requirements.