ISO 13485

What is ISO 13485?

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.

PDCA Model for ISO 13485:2016

Necessity & Effects of Certification

Necessity Expected Effects
  • Essential for medical device companies exporting products to overseas markets
  • EU guideline requirements
  • Foreign buyers request for ISO 13485 and CE marks when exporting medical devices
  • Several countries (Canada, etc.) have established a law to acquire ISO 13485 certification.
  • Increased accessibility to global markets with certification
  • Improvement in the entire process with reviews
  • Increased efficiency, cost reduction and supply chain performance monitoring
  • Verification of safer and more effective medical device production
  • Fulfilling regulatory requirements and customer expectation
  • Effective product traceability and recall system