年轻工厂的质量体系如今收获了成功，其背后却是公司管理层与所有员工两年的艰辛努力！
Although quality system in this young factory actually had a successful harvest, there had been two years of hard work behind, both by company's management team and by all its employees.
工厂的质量体系是否已通过质量体系认证?（如有，请提供证书复印件） 。请说明最 近一次审核的日期及结论。
Whether or not the factory has obtained the certificates of quality system certification (please provide the copy of the certificates) and indicate the date and conclusion of last audit).
工厂是否按认证实施规则的要求建立文件化质量体系？
Has the factory established and maintained a documented quality system according to the requirement of the implementation rules for certification?
在建立质量体系满足“3c”工厂质量保证能力要求的过程中，针对10条要求的具体规定，提出了一些问题。
During the process of quality system establishment to meet the requirements of "3c" factory quality assurance capability, aimed at actual regulations for 10 requirements, some questions are raised.
依据客户之标准及公司政策对被指派的工厂进行质量体系评审。
Carry out quality related audit at designated factories according to customers' standards and Company policy.
每个工厂应建立并保持一个质量体系是适宜的特定医疗器械的设计或制造的，并且符合要求的这一部分。
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device (s) designed or manufactured, and that meets the requirements of this part.
每个工厂应建立并保持一个质量体系是适宜的特定医疗器械的设计或制造的，并且符合要求的这一部分。
Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device (s) designed or manufactured, and that meets the requirements of this part.
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