"Process", the process of the development of things; Stage. In quality management, "process" is defined as a set of activities that use inputs to achieve expected results. Introduce "process", the process of the development of things; Stage.

The specific process standards need to be reviewed in official website.

И o13485Chinese is called "legal requirements of medical equipment quality control system". Because medical devices are special products for saving lives, preventing diseases and curing diseases, it is not enough to standardize them only according to the general requirements of ISO9000 standard. Therefore, ISO issued ISO 13485: 1996 version standards (YY/T0287 and YY/T0286).