The ISO-13485 standard specifically relates to the manufacture of medical devices, an important segment of ATM’s business. The ISO 13485 standard requires awareness and promotion of regulatory requirements for medical devices, specific requirements for inspection and traceability, and documentation and validation of processes for sterile medical devices.
The ISO 9001 standard is a general manufacturing standard for quality management systems, which calls not only for implementing and maintaining a quality program, but also for showing continuous improvement.
