ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The primary objective of ISO 13485 was to facilitate harmonized medical device regulatory requirements for quality management systems. It includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability.
Advantages Of ISO 13485:2003
- Customer satisfaction
- Reduced operating costs
- Proven business credentials through independent verification against recognized standards
- Improved stakeholder relationships