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This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
- Establish a quality system for medical devices
- Document your medical device quality system
- Support quality
- Focus on customers
- Establish a quality policy
- Perform quality planning
- Control your quality management system
- Carry out management reviews
- Provide quality resources
- Provide quality personnel
- Provide quality infrastructure
- Provide quality environment
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.