1、目的


                                                                                                                                  


為確保產品或質量體系有重大改變時能及時準確通知公告機構。  


                                                                                                                        


2、范圍


                                                                                                                    


在公司產品或質量體系重大改變時發布通知的職責、工作程序、內容和要求。



 


3、職責


                                                                                                                                          


3.1管理者代表負責產品或質量體系有重大改變時通知公告機構，并對更改事項的總體進行控


制。


                                                                                                                                            


3.2技術部負責制訂產品或質量體系重大改變的通知程序和組織相關文件的修改及發放的控


制。



 


4、控制程序


                                                                                                                             


4.1當產品或質量體系發生重大改變前，應以文件形式通知公告機構。


                                                                                                                                                            


4.2需通知公告機構的內容包括：


                                                                                                                                                            


4.2.1 更改簡述                                                                                                                                                       


a)申請者；                                                                                                                                                 


b)更改通知編號；                                                                                                                                           


c)申請日期；                                                                                                                                               


d)更改類型及主要內容；                                                                                                                                               


e)證書號碼；                                                                                                                                               


f)證書是否需修改或更換。


                                                                                                                                  


4.2.2 更改類型                                                                                                                                                       


A、產品更改所涉及的范圍                                                                                                                                              


a)預期用途；      


b)技術指標；                        


c)安全性能指標；


d)原材料；                                                                                                                                                 


e)生產工藝；                                                                                                                                               


f)附件說明；                                                                                                                                               


g)對使用者的指導（包括使用說明書）；                                                                                                                                              


h)產品標簽、圖示、符號；                                                                                                                                             


I)其它。                                                                                                                                                   


B、體系更改所涉及的范圍。                                                                                                                                            


a)    所有者；                                                               

                                                                                                                      


b)生產場地和環境；                                                                                                                                         


c)管理職責；                                                                                                                                               


d)生產過程或關鍵工序；                                                                                                                                               


e)檢測手段；                                                                                                                                               


f)售后監督體系；


g)質量手冊、程序文件的修改；                                                                                                                                         


h)其它。


                                                                                                                                  


4.3當需要進行上述更改時，由技術部編制涉及更改的文件和記錄，列出更改原因及更改理由，


報經管理者代表審核。管理者代表應在7天內，通知公告機構 。


                                                                                                                            


4.4根據更改分類規則，如為實質性的更改，則由公告機構重新評審、驗證和批準。



 


4.5實施更改后，其產品和體系應仍然符合MDD93/42/EEC的有關要求。 


                                                                                                                                                  


4.6對重大更改后的有關文件和資料由質檢部負責進行發放和管理控制。



 


5、相關文件


                                                                                                                                          


5.1文件控制程序YH/QP-01    



 


6、記錄文件


                                                                                                                                          


6.1更改通知書QP28-01