檢測機構想要申報實驗室認可，獲取認可資質，做好文件控制工作，是其中一個及其重要的環節。

　　為(wei)什么(me)這么(me)說(shuo)呢(ni)，首先我們(men)來看(kan)看(kan)CNAS-CL01《檢測和校準實驗室能力(li)認(ren)可準則(ze)》。準則(ze)中(zhong)4.2.1“應將其政(zheng)策(ce)、制(zhi)度、計劃、程(cheng)序(xu)和指導書制(zhi)訂(ding)成文件”，隨后(hou)4.3中(zhong)單獨(du)形成一個章節“文件控(kong)(kong)(kong)制(zhi)”。可見文件的(de)控(kong)(kong)(kong)制(zhi)在準則(ze)中(zhong)所(suo)占(zhan)比(bi)重還是相當大(da)的(de)，做好文控(kong)(kong)(kong)工作是申報實驗室認(ren)可的(de)基礎。

　　如何做好文(wen)(wen)控(kong)工(gong)作呢?首先應該明確文(wen)(wen)件(jian)(jian)的(de)概念。文(wen)(wen)件(jian)(jian)是以文(wen)(wen)字或圖示(shi)描述管(guan)理(li)內容或業(ye)務內容、通過規(gui)定(ding)程(cheng)序由有權人(ren)員簽(qian)署發布、要求接收者(zhe)據此做出規(gui)范反應的(de)電(dian)子(zi)(zi)(zi)文(wen)(wen)檔或紙(zhi)質(zhi)文(wen)(wen)檔。一般形式(shi)為硬拷(kao)貝類和(he)電(dian)子(zi)(zi)(zi)類。硬拷(kao)貝就(jiu)是大(da)家常見的(de)紙(zhi)質(zhi)版文(wen)(wen)件(jian)(jian)，電(dian)子(zi)(zi)(zi)版一般體現為PDF和(he)WORD形式(shi)。

　　為(wei)了(le)便于(yu)識別，通常會(hui)賦予文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)一個唯一性(xing)編(bian)(bian)(bian)號(hao)，各個實(shi)(shi)驗(yan)(yan)室(shi)(shi)在進(jin)(jin)(jin)(jin)行(xing)編(bian)(bian)(bian)號(hao)時(shi)，可(ke)(ke)(ke)結(jie)合(he)公司的(de)(de)企業(ye)文(wen)(wen)(wen)(wen)(wen)(wen)化，將(jiang)公司的(de)(de)縮寫、LOGO融入編(bian)(bian)(bian)號(hao)規(gui)則(ze)當(dang)(dang)中。對(dui)于(yu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)的(de)(de)管(guan)理首先應該確(que)定一個范(fan)圍，一般(ban)以(yi)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)控制清單”來(lai)(lai)體(ti)(ti)現。清單內(nei)的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)根(gen)據其來(lai)(lai)源可(ke)(ke)(ke)分(fen)為(wei)外(wai)(wai)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)和(he)內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)，顧名思義，內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)就是(shi)實(shi)(shi)驗(yan)(yan)室(shi)(shi)自(zi)己編(bian)(bian)(bian)寫的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)，外(wai)(wai)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)是(shi)實(shi)(shi)驗(yan)(yan)室(shi)(shi)為(wei)了(le)滿足自(zi)身需求而(er)引用的(de)(de)相(xiang)關文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)，包括認(ren)(ren)可(ke)(ke)(ke)委準(zhun)則(ze)、規(gui)則(ze)、指南、檢測(ce)(ce)用的(de)(de)標(biao)準(zhun)方法(fa)以(yi)及參考書籍等(deng)。確(que)認(ren)(ren)了(le)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)的(de)(de)管(guan)理范(fan)圍，接下來(lai)(lai)就要(yao)(yao)(yao)(yao)將(jiang)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)“傳達(da)至有(you)關人(ren)員(yuan)(yuan)”，被(bei)其“理解、獲取和(he)執(zhi)行(xing)”。一般(ban)通過(guo)(guo)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)發放回收記錄”來(lai)(lai)體(ti)(ti)現。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)的(de)(de)發放類型及份數(shu)需要(yao)(yao)(yao)(yao)根(gen)據實(shi)(shi)驗(yan)(yan)室(shi)(shi)需求而(er)定，例(li)如(ru)體(ti)(ti)系文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)需要(yao)(yao)(yao)(yao)全體(ti)(ti)人(ren)員(yuan)(yuan)進(jin)(jin)(jin)(jin)行(xing)學習使(shi)用，而(er)檢測(ce)(ce)標(biao)準(zhun)則(ze)僅(jin)僅(jin)針對(dui)于(yu)檢測(ce)(ce)人(ren)員(yuan)(yuan)，因此發放份數(shu)肯(ken)定是(shi)不同的(de)(de)。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)在使(shi)用過(guo)(guo)程中，相(xiang)關人(ren)員(yuan)(yuan)會(hui)對(dui)其適用性(xing)提出質疑，這也是(shi)體(ti)(ti)系持續(xu)改進(jin)(jin)(jin)(jin)的(de)(de)一種(zhong)表現形(xing)式。內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)實(shi)(shi)驗(yan)(yan)室(shi)(shi)人(ren)員(yuan)(yuan)在日常使(shi)用過(guo)(guo)程中可(ke)(ke)(ke)隨時(shi)提出文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)的(de)(de)修(xiu)訂申(shen)請(qing)，而(er)實(shi)(shi)驗(yan)(yan)室(shi)(shi)還會(hui)定期(qi)對(dui)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)進(jin)(jin)(jin)(jin)行(xing)審(shen)核，產(chan)生“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)評審(shen)記錄”，來(lai)(lai)確(que)認(ren)(ren)相(xiang)關內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)是(shi)否(fou)需要(yao)(yao)(yao)(yao)修(xiu)訂。如(ru)果有(you)修(xiu)訂需求，相(xiang)關人(ren)員(yuan)(yuan)填(tian)寫“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)修(xiu)訂申(shen)請(qing)”，經過(guo)(guo)審(shen)核、批準(zhun)，方可(ke)(ke)(ke)進(jin)(jin)(jin)(jin)行(xing)修(xiu)訂。審(shen)核人(ren)和(he)批準(zhun)人(ren)必須(xu)是(shi)原文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)編(bian)(bian)(bian)寫時(shi)審(shen)核批準(zhun)的(de)(de)崗位。對(dui)于(yu)外(wai)(wai)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)，一般(ban)通過(guo)(guo)查新來(lai)(lai)確(que)認(ren)(ren)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)的(de)(de)最新有(you)效，填(tian)寫“標(biao)準(zhun)有(you)效性(xing)確(que)認(ren)(ren)記錄”。當(dang)(dang)實(shi)(shi)驗(yan)(yan)室(shi)(shi)發放的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)數(shu)量較少時(shi)，可(ke)(ke)(ke)通過(guo)(guo)借閱(yue)(yue)、復(fu)印(yin)等(deng)方式獲取文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)內(nei)容(rong)，借閱(yue)(yue)復(fu)印(yin)時(shi)應填(tian)寫“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)借閱(yue)(yue)復(fu)印(yin)登記表”。
 

　　隨著科技的(de)(de)飛(fei)速發(fa)展，越(yue)來越(yue)多的(de)(de)實驗(yan)室將LIMS系(xi)統(tong)引(yin)入到實驗(yan)室日常(chang)(chang)管(guan)理當(dang)中。文(wen)(wen)(wen)(wen)件(jian)的(de)(de)控(kong)制(zhi)也逐漸被融(rong)合(he)進(jin)來，但本文(wen)(wen)(wen)(wen)僅就現階(jie)段大多數(shu)實驗(yan)室如何管(guan)理文(wen)(wen)(wen)(wen)件(jian)進(jin)行(xing)簡(jian)單的(de)(de)闡述。目前電(dian)(dian)子文(wen)(wen)(wen)(wen)件(jian)僅僅是作(zuo)(zuo)為(wei)紙(zhi)質版文(wen)(wen)(wen)(wen)件(jian)的(de)(de)輔助工具(ju)，以PDF格(ge)式(shi)發(fa)布(bu)在(zai)各檢(jian)測機構(gou)或(huo)其(qi)母體的(de)(de)網(wang)絡公示平(ping)臺上，共有權限的(de)(de)人(ren)進(jin)行(xing)學習(無法下載和修改)，同時實驗(yan)室會制(zhi)定一(yi)名專(zhuan)人(ren)負責電(dian)(dian)子文(wen)(wen)(wen)(wen)件(jian)的(de)(de)更新(xin)替換。電(dian)(dian)子文(wen)(wen)(wen)(wen)件(jian)的(de)(de)管(guan)理按照紙(zhi)質版文(wen)(wen)(wen)(wen)件(jian)的(de)(de)要求進(jin)行(xing)管(guan)理。文(wen)(wen)(wen)(wen)件(jian)的(de)(de)控(kong)制(zhi)是實驗(yan)室認可的(de)(de)基礎，文(wen)(wen)(wen)(wen)控(kong)工作(zuo)(zuo)同時也是一(yi)個繁瑣的(de)(de)工作(zuo)(zuo)，可謂(wei)牽(qian)一(yi)發(fa)而動全身，因此在(zai)日常(chang)(chang)工作(zuo)(zuo)中安排的(de)(de)人(ren)員應(ying)耐心、細致(zhi)。

　　本文(wen)針對(dui)文(wen)件如何管(guan)理，以記錄的形式向廣大讀者進行(xing)了(le)闡述，這種形式我個人覺得比(bi)較直觀，如有(you)不妥可進行(xing)互動交流與溝通。

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