ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach. These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE Marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.

 

Certification to ISO 13485 takes place when an accredited third party, such as ISO Certification Body, visits an organization, assesses the quality management system and, if satisfactory, issues a certificate confirming that the organization’s quality management system meets the requirements of this standard. ISO 13485 quality management systems certificate is an objective, accredited, recognized evidence of the Organization’s commitment to quality systems and helps it demonstrate this to its customers and regulators. ISO 13485 is becoming widely accepted as the international standard to address medical device requirements around the world.

 

The standard can be used by manufacturers to demonstrate compliance to applicable regulatory requirements, and by other organizations whose related services support medical device manufacturers.