质量手册发布令

 

 

发 布 令

 

 

本公司质量手册依据下列标准，结合本公司生产经营实际情况编制完成了《质量手册》第一版，现予以批准颁布实施。

 

 

GB/T 19001：2000/ISO 9001：2000《质量管理体系  要求》

 

 

YY/T 0287-2003/ISO 13485：2003 《医疗器械 质量管理体系用于法规的要求》

 

 

YY/T 0316-2008/ISO14971: 2007  《医疗器械 风险管理对于医疗器械的应用》

 

 

中国与医疗器械相关的法律法规

 

 

美国FDA现行法案和质量体系法规（QSR）

 

 

欧洲医疗器械指令MDD 93/42/EEC

 

 

日本厚生省法令No.169/No.2，日本药事法

 

 

其他一些产品输入国的法律法规要求

 

 

 

 

 

本手册是公司质量管理体系的法规性文件，是指导公司建立并实施质量管理体系的行为准则和质量保证能力的表述。全体员工必须遵照执行，以维护公司质量管理体系的正常运行和持续保持质量管理体系的适宜性和有效性。

 

 

总经理：

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issue of Quality Manual

 

 

Notification of Issue

 

 

The quality manual of our company is on basis of the following standards. We compiled this first version of Quality Manual in combination with the actual production and management situation of company, and now it is issued for implementation.

 

 

GB/T 19001: 2000/ ISO 9001: 2000 Requirements for Quality Management System

 

 

YY/T 0287-2003/ ISO 13485: 2003 Medical Device - Quality Management System Using In Regulation's Request

 

 

YY/T 0316-2008/ ISO14971: 2007 Medical Device - Application of Risk Management Using in Medical Device

 

 

Related laws and regulations on medical device in China

 

 

FDA current acts and quality system laws in America (QSR)

 

 

European Medical Device Instruction MDD 93/42/EEC

 

 

Act of Koseisho Province in Japan No.169/No.2，

 

 

Pharmacy Law of Japan

 

 

Requirement in laws and regulations of other product input countries

 

 

 

 

 

This manual is the regulation document of company's quality management system which guides the establishment of company, expresses the code of conducts on implementing the quality management system and describes the capability to guarantee quality. The staff should comply to implement to maintain the regular running of the quality management system and continuously keep the suitability and efficiency of the quality management system.

 

                                                             The general manager