ISO13485认证 医疗器械质量管理体系(YY/T0287 和YY/T0288)
发布时间: 2016-05-22 01:12 点击:
ISO13485 Chinese called "medical equipment quality management system" as medical apparatus and instruments is to heal the wounded and rescue the dying, to prevent and cure diseases of special products, only according to the general requirements of ISO9000 standard to regulate is not enough;
This ISO issued ISO13485:1996 version of the standard and YY/T0288 YY/T0287, of the quality management system of medical equipment manufacturing enterprises put forward the special requirements, for the quality of medical devices to achieve safe and effective plays a good role in promoting.