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一、前言ＩＳＯ 90 0 0族标准是世界上许多经济发达国家质量管理实践经验的科学总结 ,具有通用性和指导性。因此 ,实施ＩＳＯ90 0 0标准有利于企业提高产品质量 ,保护消费者的利益 ,在医疗器械行业更是如此。目前 ,世界各国医疗器械行业已经开始实施ＩＳＯ 90 0 1:2 0 0 0标准
I. INTRODUCTION The ISO 90000 family standard is a scientific summary of the quality management practice experience of many economically developed countries in the world. It is versatile and instructive. Therefore, the implementation of the ISO900 standard is conducive to enterprises to improve product quality and protect the interests of consumers, especially in the medical device industry. At present, the medical device industry in various countries has already implemented the ISO 90 0 1:2000 standard.