The ISO 13485 International Standard provides requirements for medical device and equipment manufacturers to improve their quality management systems. It lays forth procedures for reducing manufacturing processes and system failures. This guideline also ensures that medical equipment continues to improve in quality. It is important to understand that ISO 13485 Certification does not specify quality requirements. It only specifies the requirements for a manufacturer’s quality management system (QMS). A company that implements and adheres to this standard will improve its product and service.