Astrodyne TDI Production Facilities are certified to Quality Management Standard ISO9001:2015. In addition, various facilities have additional certifications to meet the needs of the customers and their end product.
ISO 13485:2003 specifies requirements for a quality management system with the focus on the Ability to provide medical devices that consistently meet customer and regulatory requirements which are applicable to medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. As a result, each location with ISO 13485 certification also maintains a separate ISO 9001 certificate.