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實(shí)驗(yàn)室資質(zhì)認(rèn)定評(píng)審工作-文庫(kù)吧資料

2024-11-09 17:42本頁(yè)面
  

【正文】 .....1 3 職責(zé).........................................................................................................1 評(píng)審組長(zhǎng)...............................................................................................1 副組長(zhǎng)...................................................................................................1 評(píng)審員...................................................................................................1 實(shí)習(xí)評(píng)審員............................................................................................2 技術(shù)專家...............................................................................................2 4 評(píng)審過(guò)程..................................................................................................2 任務(wù)接收...............................................................................................2 文件資料審查........................................................................................2 現(xiàn)場(chǎng)評(píng)審策劃........................................................................................2 現(xiàn)場(chǎng)評(píng)審工作預(yù)備會(huì)..............................................................................3 現(xiàn)場(chǎng)評(píng)審活動(dòng)........................................................................................4 首次會(huì)議............................................................................................4 現(xiàn)場(chǎng)觀察、完善評(píng)審日程表...................................................................4 確認(rèn)現(xiàn)場(chǎng)試驗(yàn).....................................................................................5 現(xiàn)場(chǎng)評(píng)審..........................................................................................5 召開(kāi)座談會(huì)...............................................………………………………6 評(píng)審組內(nèi)部會(huì).................................................………………………….7 與實(shí)驗(yàn)室溝通................................................…………………………..7 末次會(huì)議..........................................................................................7 后續(xù)工作.............................................………………………………….8 跟蹤驗(yàn)證.............................................................................................8 5 現(xiàn)場(chǎng)評(píng)審時(shí)常遇問(wèn)題的處理.....................................................................8 現(xiàn)場(chǎng)試驗(yàn)/測(cè)量審核/盲樣試驗(yàn)結(jié)果處理..................................................8 對(duì)申請(qǐng)認(rèn)定項(xiàng)目/參數(shù)的檢測(cè)經(jīng)歷要求...........................................8 方法的認(rèn)可要求...........................................................................9 涉及能力驗(yàn)證的要求..............................................................................9 對(duì)實(shí)驗(yàn)室評(píng)估測(cè)量不確定度的要求.......................................................9 對(duì)量值溯源有效性的要求....................................................................10 授權(quán)簽字人的確認(rèn)...............................................................................11 不符合項(xiàng)和缺此項(xiàng)要求........................................................................11 不適用項(xiàng)要求......................................................................................12 對(duì)有移動(dòng)實(shí)驗(yàn)室的要求.......................................................................12 關(guān)于實(shí)驗(yàn)室符合相關(guān)法律法規(guī)的要求...................................................12 對(duì)于多場(chǎng)所的現(xiàn)場(chǎng)評(píng)審問(wèn)題................................................................12 初次評(píng)審對(duì)實(shí)驗(yàn)室質(zhì)量管理體系運(yùn)行記錄審查的起始時(shí)間...................13 關(guān)于分包...........................................................................................13 關(guān)于租/借用設(shè)備................................................................................13 關(guān)于儀器設(shè)備的期間核查...................................................................13 關(guān)于關(guān)鍵技術(shù)人員的兼職...................................................................14 關(guān)于“評(píng)審組確認(rèn)的檢測(cè)能力”表.........................................................14 現(xiàn)場(chǎng)評(píng)審時(shí),實(shí)驗(yàn)室提出更改認(rèn)定范圍.................................................14 現(xiàn)場(chǎng)評(píng)審時(shí),評(píng)審人日數(shù)需要調(diào)整.......................................................14 評(píng)審員不能按計(jì)劃參加評(píng)審................................................................14 中途停止現(xiàn)場(chǎng)評(píng)審..............................................................................14 關(guān)于整改期限.....................................................................................14 6 監(jiān)督評(píng)審................................................................................................14 7 復(fù)評(píng)審....................................................................................................16 8 擴(kuò)項(xiàng)評(píng)審................................................................................................17 9 標(biāo)準(zhǔn)變更評(píng)審.........................................................................................18 10 授權(quán)簽字人變更評(píng)審.............................................................................18 11實(shí)驗(yàn)室檢驗(yàn)場(chǎng)所地址變更評(píng)審.................................................................19 12 填寫評(píng)審報(bào)告及工作用表的要求............................................................19 13 對(duì)評(píng)審員的評(píng)價(jià)....................................................................................21 14 工作記錄..............................................................................................21 15 相關(guān)表格..............................................................................................22版次:A實(shí)驗(yàn)室資質(zhì)認(rèn)定評(píng)審工作指導(dǎo)書修訂:0實(shí)驗(yàn)室資質(zhì)認(rèn)定評(píng)審工作指導(dǎo)書 目的為規(guī)范實(shí)驗(yàn)室資質(zhì)認(rèn)定評(píng)審工作,保證評(píng)審結(jié)果公正、準(zhǔn)確,評(píng)審過(guò)程、評(píng)審要求和評(píng)審方法一致,編制本指導(dǎo)書。對(duì)封存的上次現(xiàn)場(chǎng)評(píng)審資料啟封時(shí)應(yīng)通過(guò)任務(wù)下達(dá)部門的項(xiàng)目負(fù)責(zé)人同意,查閱完后評(píng)審組長(zhǎng)應(yīng)負(fù)責(zé)將其再次封存?,F(xiàn)場(chǎng)評(píng)審結(jié)束后,評(píng)審組長(zhǎng)負(fù)責(zé)現(xiàn)場(chǎng)封存的材料應(yīng)包括:現(xiàn)行有效的質(zhì)量手冊(cè)、現(xiàn)場(chǎng)實(shí)驗(yàn)報(bào)告及原始記錄、附表2(現(xiàn)場(chǎng)試驗(yàn)項(xiàng)目匯總表)復(fù)印件、不符合項(xiàng)復(fù)印件。對(duì)不同的檢測(cè)能力: ○1對(duì)于管理體系的評(píng)價(jià)除按照CNAS評(píng)審檢查表之外,還必須增加《實(shí)驗(yàn)室資質(zhì)認(rèn)定特殊要求評(píng)審表》的內(nèi)容; ○2申請(qǐng)資質(zhì)認(rèn)定的項(xiàng)目應(yīng)按照本指導(dǎo)書的要求對(duì)能力進(jìn)行獨(dú)立考核。d)檢測(cè)/校準(zhǔn)方法規(guī)定或儀器本身規(guī)定必須期間核查的設(shè)備。b)重要參數(shù)檢測(cè)的儀器設(shè)備即對(duì)產(chǎn)品關(guān)鍵或主要參數(shù)檢測(cè)質(zhì)量影響大的。滿足下列條件之一的儀器設(shè)備,當(dāng)具備相應(yīng)的核查標(biāo)準(zhǔn)和實(shí)施條件時(shí)須進(jìn)行期間核查。c)利用不同批的標(biāo)準(zhǔn)物質(zhì)對(duì)同一被測(cè)樣所出具的計(jì)量數(shù)據(jù)的結(jié)果來(lái)驗(yàn)證。,驗(yàn)證的方法包括:a)同一被測(cè)樣品的實(shí)驗(yàn)室間比對(duì)。d)相關(guān)計(jì)量行政部門規(guī)定的一次性檢定計(jì)量器具。b)工具性的計(jì)量器具,即只作為維護(hù)工具、不作為測(cè)量工具的器具。,其人員兼職按上述要求進(jìn)行評(píng)審,但有多個(gè)名義稱謂的機(jī)構(gòu),其環(huán)境設(shè)施和儀器設(shè)備所有權(quán)必須明確歸屬權(quán),對(duì)項(xiàng)目范圍也應(yīng)合理界定。(質(zhì)量負(fù)責(zé)人、技術(shù)負(fù)責(zé)人、授權(quán)簽字人、內(nèi)審員、監(jiān)督員、檢驗(yàn)員等)兼職的問(wèn)題。 實(shí)驗(yàn)室資質(zhì)認(rèn)定標(biāo)志按有關(guān)規(guī)定實(shí)施,應(yīng)在資質(zhì)認(rèn)定證書附表中確定的項(xiàng)目和標(biāo)準(zhǔn)范圍內(nèi)、以及證書有效期內(nèi)使用,沒(méi)有認(rèn)定的項(xiàng)目和標(biāo)準(zhǔn)不得使用該標(biāo)志。d)有意妨礙評(píng)審工作,以致無(wú)法進(jìn)行評(píng)審。b)質(zhì)量管理體系控制失效?,F(xiàn)場(chǎng)評(píng)審時(shí),評(píng)審員由于特殊情況,不能按評(píng)審計(jì)劃到達(dá)評(píng)審現(xiàn)場(chǎng)或需提前離開(kāi)評(píng)審現(xiàn)場(chǎng)時(shí),評(píng)審組長(zhǎng)應(yīng)及時(shí)向質(zhì)量管理與認(rèn)證處報(bào)告,并在評(píng)審報(bào)告中“需要說(shuō)明的問(wèn)題”欄中予以說(shuō)明。,實(shí)驗(yàn)室提出更改資質(zhì)認(rèn)定范圍評(píng)審組進(jìn)入現(xiàn)場(chǎng)評(píng)審時(shí),不接受擴(kuò)大資質(zhì)認(rèn)定范圍的申請(qǐng)?,F(xiàn)場(chǎng)評(píng)審時(shí),實(shí)驗(yàn)室的質(zhì)量管理體系運(yùn)行12個(gè)月以上的,可審查12個(gè)月內(nèi)體系運(yùn)行的記錄。此種情況發(fā)生時(shí),評(píng)審組長(zhǎng)應(yīng)立即向質(zhì)量管理與認(rèn)證處工作負(fù)責(zé)人匯報(bào)?,F(xiàn)場(chǎng)評(píng)審過(guò)程中,評(píng)審組長(zhǎng)應(yīng)與在各分場(chǎng)所實(shí)驗(yàn)室評(píng)審的評(píng)審組保持聯(lián)系,及時(shí)溝通情況。各分場(chǎng)所的評(píng)審組應(yīng)在現(xiàn)場(chǎng)完成評(píng)
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