ISO 13485 Medical Device Quality Management System is a requirement for regulatory purpose, containing matters related to development, implementation and maintenance of quality management system designed for medical device manufacturers and suppliers.
Companies manufacturing and selling medical devices and parts based on medical device quality management system should be certified with ISO 13485.
ISO 13485 seems similar to ISO 9001. However, specific ISO 9001 articles are excluded and special requirements on medical devices are included. Thus, ISO 9001 cannot be replaced with ISO 13485.
Just like other certificates, ISO 13485 is valid for 3 years. Its validity is maintained with a post-review once a year. Certification is extended with a review for renewal before the certification expires.