ISO 13485:2003 (Quality Management System for Medical Devices)
The ISO 13485:2003 is an international standard for Quality Management Systems specifically designed for the manufacture of medical devices and can also be used for the development production, installation and servicing of medical devices. Its objective is to harmonize the medical device regulatory requirements and to increase the credibility of an organization with potential customers.
This standard specifies can lead to increased efficiency, quality and improved customer services for the requirements of a quality management system. Helps an organization to explain its ability to provide medical devices, related services and commitment to quality that continuously meet customer requirements and regulatory requirements applicable to medical devices.