The ISO 13485:2016 quality management System(QMS) for medical devices is a standalone that was derived from the widely used and respected ISO 9000 quality management standard series. In other words, ISO:13485 specifies requirements for a quality management system in situations where a company must show that it can consistently deliver medical devices and related services that meet customer and applicable regulatory requirements. The process-based ISO 9000 model is modified for a regulated medical device manufacturing environment in ISO 13485. Although the concepts of Plan, Do, Check, and Act from the ISO 9001 process model are the foundation of ISO 13485, it was created for regulatory compliance. As a result, it is more prescriptive in character and necessitates a quality management system with more extensive documentation.

In order to assist medical device manufacturers in creating quality management systems that develop and sustain the efficacy of their processes, ISO 13485 was created. It guarantees that medical devices are consistently designed, developed, produced, installed, and delivered in a manner that is safe for their intended use. A medical device organization may use to assist in demonstrating compliance with medical device industry laws and regulations.