Based on the ISO 9001 process approach to quality management, ISO 13485 helps organizations that provide medical devices or services meet regulatory requirements and establish a management system.
By certifying to ISO 13485, your organization will be able to:
- Demonstrate compliance to regulatory requirements
- Establish an effective system for risk management
- Communicate effectively with customers, suppliers and other interested parties about operational control
Certifying your quality management system to ISO 13485 increases your organization's access to both U.S. and international markets. For example, ISO 13485 certification meets Good Manufacturing Practice compliance in the United States.
NSF-ISR certifies any organization that manufactures medical devices, including unfinished implantable medical device components. NSF-ISR does not currently certify companies that produce finished implantable medical devices.