Focus on Quality Management Systems
ISO 13485 – Medical Devices Industry
The ISO 13485 standard specifies a Quality Management System for the medical devices industry. Businesses that comply with ISO 13485 also meet applicable ISO 9001 and FDA regulatory requirements. Because of the application of medical devices, special system and process requirements for ISO 13485 include the following:
- Understanding customer requirements
- Requirements for cleanliness, sterilization, and contamination management
- Clinical evaluations and trials
- Traceability and verification controls for purchased components
- Special requirements for implantable devices
- Controls for labeling and packaging
- Guidelines for shelf-life and preservation of the product
