What is ISO 13485?
ISO 13485:2003 is another sector-specific quality standard such as AS9100 and TL 9000 but for the medical device industry. The standard’s full name is ISO 13485:2003, Medical Devices Quality Management Systems Requirements for Regulatory Purposes. Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products. Certification to ISO 13485 offers a major competitive edge for medical device companies. Far-sighted firms are planning either for first-time registration to IS
