ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognized as an aid in supporting compliance with the Medical Device Directive.
"Achieving certification to ISO 13485, the international quality standard for medical device companies, means that AUE has effectively implemented processes and documented requirements to achieve customer satisfaction. This includes having a corrective action process to investigate problems that occur or issues found during internal audits and ideally eliminate them from ever happening again. This not only helps us understand and meet the needs of our customers, it also leads to continuous improvement of our products and processes. For AUE employees, an ISO certified quality system means they know what their job is and through training, how to do it. And having documented requirements and customer-focused quality goals means our employees know what is expected of them, and management is aware of what is needed in order to provide the resources to achieve our goals."