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?
针对采购物品中有害物质之检验与识别建立文件化程序。
Establish a documented procedure for the inspection and identification of Hazardous substances included in purchased goods.
公司对灭菌过程的确认建立文件化程序，灭菌过程确认应在最初使用前进行。
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
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