The medical device industry has always used the ISO13485 standard (China's equivalent standard number is YY / T 0287) as the basis for quality management system certification. In the past, this standard was developed based on the ISO9001: 1994 standard to increase the special requirements of the medical device industry. Therefore, meeting ISO13485 also meets the requirements of ISO9001: 1994. Since the ISO9001: 2000 standard was promulgated, ISO / TC210 has been discussed repeatedly, and a new ISO13485: 2003 international standard was promulgated in 2003. The new standard has changed a lot from the old standard, and it has many characteristics of the medical device industry.
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