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實驗室評審前期該準備哪些內容?有了這個清單質量負責人再也不用頭疼了!

   2017-09-06 食品實驗室服務公眾號437
核心提示:portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: i
 portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">實驗評審內容準備

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">1、實驗室該有的人員到位情況;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">2、實驗室經理/主管、技術主管、質量主管、監督員、取樣人員的任命;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">3、實驗室組織結構圖;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">4、指定關鍵管理人員(實驗室經理/主管、技術主管、質量主管、監督員、取樣人員)的代理人;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">5、有關三級文件的建立,如實驗室內部文件管理、記錄管理、樣品管理、環境管理、外出抽樣;SOP、標準物質管理/標準溶液SOP、實驗室廢棄物管理SOP、食品檢測應急預案等;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">6、實驗室現場使用的所有文件和標準是否受控;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">7、如有分包,分包方名冊及資質檔案建立情況;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">8、關鍵試劑的技術性驗收記錄;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">9、供應商評估、資質檔案與合格供應商名冊的建立;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">10、年度員工培訓計劃;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">11、檢測人員的技術檔案(含學歷證明、各類資質證明、技術能力評估表等);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">12、實驗室員工是否接受ISO17025和質量管理體系的培訓;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">13、目前環境滿足檢測方法/標準的情況;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">14、各不相容區域是否有隔離以防止交叉污染;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">15、實驗室關鍵區域是否有出入授權標識;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">16、所有檢測標準/方法是否進行了方法確認/證實,并保存記錄;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">17、如果不同的檢測人員對同一份標準的理解和操作存在不同,是否制定檢測SOP;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">18、定量檢測項目是否有進行不確定度評估,提供評估報告;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">19、需要的儀器設備是否已經到位;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">20、××年度的設備校準/維護保養計劃是否制定;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">21、需要校準的設備是否已經送外校準/檢定;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">22、關鍵設備的檔案是否建立;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">23、設備在使用前是否進行了確認,并有記錄;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">24、設備校準/有效狀態的標識狀況;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">25、××年度設備期間核查計劃;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">26、抽樣計劃和程序在抽樣地點是否能夠獲得;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">27、申請書附表準備,包括以下附表:

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">附表1-1:實驗室授權簽字人一覽表(中、英文)

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表1-2:授權簽字人申請表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表2-1:申請的檢測能力范圍(中、英文)

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表3:實驗室人員一覽表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表4-1:檢測實驗室儀器設備/標準物質配置表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表5-1:實驗室參加能力驗證/測量審核一覽表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表5-2:實驗室參加實驗室間比對一覽表

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">  附表8:參加能力驗證活動的計劃表
portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">28、實驗室平面圖;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">29、實驗室所從事活動的說明,以及當實驗室是法人實體的一部分時,兩者關系的說明。(NJTC-QM質量手冊有描述);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">30、對申請認可的標準/方法現行有效性進行的核查情況(提交核查報告,自行核查時核查報告需要包含核查人、時間、方式、結果);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">31、對于初次申請認可和申請擴大認可范圍的實驗室,在申請范圍內,至少參加一次CNAS或其承認的機構所組織的能力驗證活動,或CNAS承認的實驗室間比對,或CNAS安排的測量審核活動,且獲得滿意結果的證據,或對于不滿意結果能證明已開展了有效糾正措施的證據;

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">32、參加實驗室間比對的情況(提交實驗室間比對的結果和評價);

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">

portant; word-wrap: break-word !important; background-image: initial; background-attachment: initial; background-size: initial; background-origin: initial; background-clip: initial; background-position: initial; background-repeat: initial;">33、典型項目的檢測報告及不確定度評估報告。



 
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