1、目的


                                                                                                                                  


為確保產(chǎn)品或質(zhì)量體系有重大改變時能及時準(zhǔn)確通知公告機構(gòu)。  


                                                                                                                        


2、范圍


                                                                                                                    


在公司產(chǎn)品或質(zhì)量體系重大改變時發(fā)布通知的職責(zé)、工作程序、內(nèi)容和要求。



 


3、職責(zé)


                                                                                                                                          


3.1管理者代表負(fù)責(zé)產(chǎn)品或質(zhì)量體系有重大改變時通知公告機構(gòu)，并對更改事項的總體進(jìn)行控


制。


                                                                                                                                            


3.2技術(shù)部負(fù)責(zé)制訂產(chǎn)品或質(zhì)量體系重大改變的通知程序和組織相關(guān)文件的修改及發(fā)放的控


制。



 


4、控制程序


                                                                                                                             


4.1當(dāng)產(chǎn)品或質(zhì)量體系發(fā)生重大改變前，應(yīng)以文件形式通知公告機構(gòu)。


                                                                                                                                                            


4.2需通知公告機構(gòu)的內(nèi)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(nèi)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(chǎn)品更改所涉及的范圍                                                                                                                                              


a)預(yù)期用途；      


b)技術(shù)指標(biāo)；                        


c)安全性能指標(biāo)；


d)原材料；                                                                                                                                                 


e)生產(chǎn)工藝；                                                                                                                                               


f)附件說明；                                                                                                                                               


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


h)產(chǎn)品標(biāo)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(chǎn)場地和環(huán)境；                                                                                                                                         


c)管理職責(zé)；                                                                                                                                               


d)生產(chǎn)過程或關(guān)鍵工序；                                                                                                                                               


e)檢測手段；                                                                                                                                               


f)售后監(jiān)督體系；


g)質(zhì)量手冊、程序文件的修改；                                                                                                                                         


h)其它。


                                                                                                                                  


4.3當(dāng)需要進(jìn)行上述更改時，由技術(shù)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(jīng)管理者代表審核。管理者代表應(yīng)在7天內(nèi)，通知公告機構(gòu) 。


                                                                                                                            


4.4根據(jù)更改分類規(guī)則，如為實質(zhì)性的更改，則由公告機構(gòu)重新評審、驗證和批準(zhǔn)。



 


4.5實施更改后，其產(chǎn)品和體系應(yīng)仍然符合MDD93/42/EEC的有關(guān)要求。 


                                                                                                                                                  


4.6對重大更改后的有關(guān)文件和資料由質(zhì)檢部負(fù)責(zé)進(jìn)行發(fā)放和管理控制。



 


5、相關(guān)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