ISO 13485 quality management system for medical devices is an international standard designed to provide medical device suppliers with a common approach to applying a Quality Management System that addresses most FDA requirements. It is based on the popular ISO 9001 series with the new ISO 13485:2003 standard based on the ISO 9001:2000 standard

The intent of ISO 13485 is to provide for the development of a Quality Management System that ensures to prospective customers and regulatory bodies that the goods and services offered by the organization will meet customer and regulatory requirements. Certification to ISO 13485 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

ISO 13485 can be applied to any type or size of organization that designs, develops, produces, installs or services medical devices.