ISO 13485 is based on the ISO 9001:2000 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
The standard contains specific requirements for manufacture, installation and servicing and calls for:
- Implementation of a Quality Management System with several enhancements.
- Risk Management approach to product development and product realisation.
- Validation of processes.
- Compliance with statutory and regulatory requirements.
- Effective product traceability and recall systems.