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)說呢，首先我們來看(kan)看(kan)CNAS-CL01《檢測和(he)校準實(shi)(shi)驗(yan)室能力(li)認可(ke)準則》。準則中4.2.1“應將其(qi)政策、制(zhi)度、計劃、程序和(he)指導書制(zhi)訂成(cheng)文件”，隨后(hou)4.3中單獨形成(cheng)一(yi)個(ge)章節“文件控制(zhi)”。可(ke)見文件的控制(zhi)在準則中所占比重(zhong)還是相當大的，做好文控工作是申(shen)報實(shi)(shi)驗(yan)室認可(ke)的基(ji)礎。

　　如(ru)何(he)做(zuo)好文(wen)控工作呢?首先應該明確(que)文(wen)件(jian)(jian)的(de)概念。文(wen)件(jian)(jian)是(shi)以文(wen)字(zi)或圖示描述管(guan)理內容或業務內容、通過規定程序由有權人員簽署發布、要(yao)求(qiu)接(jie)收者據此做(zuo)出規范反(fan)應的(de)電子文(wen)檔或紙(zhi)質文(wen)檔。一般形(xing)式為硬(ying)拷(kao)貝(bei)類和(he)電子類。硬(ying)拷(kao)貝(bei)就是(shi)大家(jia)常見的(de)紙(zhi)質版(ban)文(wen)件(jian)(jian)，電子版(ban)一般體現為PDF和(he)WORD形(xing)式。

　　為了便(bian)于識別，通常會賦予文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)一(yi)個(ge)唯一(yi)性編(bian)(bian)號(hao)(hao)，各(ge)個(ge)實(shi)驗室(shi)(shi)在進行編(bian)(bian)號(hao)(hao)時(shi)，可(ke)結(jie)合公(gong)司(si)的(de)(de)(de)企(qi)業文(wen)(wen)(wen)(wen)(wen)(wen)化(hua)，將公(gong)司(si)的(de)(de)(de)縮寫、LOGO融入(ru)編(bian)(bian)號(hao)(hao)規(gui)則(ze)(ze)當(dang)中。對(dui)于文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)的(de)(de)(de)管(guan)理首先應該(gai)確(que)定(ding)(ding)一(yi)個(ge)范(fan)圍(wei)，一(yi)般以(yi)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)控制清(qing)單”來(lai)體(ti)(ti)現。清(qing)單內(nei)的(de)(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)根據(ju)其(qi)(qi)來(lai)源可(ke)分為外(wai)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)和(he)(he)內(nei)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)，顧名思義(yi)，內(nei)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)就是(shi)(shi)(shi)實(shi)驗室(shi)(shi)自己(ji)編(bian)(bian)寫的(de)(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)，外(wai)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)是(shi)(shi)(shi)實(shi)驗室(shi)(shi)為了滿(man)足自身需(xu)(xu)求而(er)(er)引用(yong)的(de)(de)(de)相關(guan)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)，包括認(ren)(ren)(ren)可(ke)委(wei)準(zhun)則(ze)(ze)、規(gui)則(ze)(ze)、指南、檢(jian)測用(yong)的(de)(de)(de)標準(zhun)方(fang)法以(yi)及參考書籍等。確(que)認(ren)(ren)(ren)了文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)的(de)(de)(de)管(guan)理范(fan)圍(wei)，接(jie)下來(lai)就要將文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)“傳達至有關(guan)人員(yuan)”，被其(qi)(qi)“理解、獲取(qu)和(he)(he)執行”。一(yi)般通過(guo)(guo)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)發(fa)放(fang)(fang)回收(shou)記錄(lu)”來(lai)體(ti)(ti)現。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)的(de)(de)(de)發(fa)放(fang)(fang)類型及份(fen)數(shu)需(xu)(xu)要根據(ju)實(shi)驗室(shi)(shi)需(xu)(xu)求而(er)(er)定(ding)(ding)，例如體(ti)(ti)系文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)需(xu)(xu)要全體(ti)(ti)人員(yuan)進行學習使(shi)用(yong)，而(er)(er)檢(jian)測標準(zhun)則(ze)(ze)僅僅針對(dui)于檢(jian)測人員(yuan)，因此發(fa)放(fang)(fang)份(fen)數(shu)肯定(ding)(ding)是(shi)(shi)(shi)不(bu)同(tong)的(de)(de)(de)。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)在使(shi)用(yong)過(guo)(guo)程(cheng)中，相關(guan)人員(yuan)會對(dui)其(qi)(qi)適(shi)用(yong)性提(ti)出質(zhi)疑，這也(ye)是(shi)(shi)(shi)體(ti)(ti)系持(chi)續(xu)改(gai)進的(de)(de)(de)一(yi)種表現形(xing)式(shi)。內(nei)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)實(shi)驗室(shi)(shi)人員(yuan)在日常使(shi)用(yong)過(guo)(guo)程(cheng)中可(ke)隨時(shi)提(ti)出文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)的(de)(de)(de)修訂(ding)申(shen)請，而(er)(er)實(shi)驗室(shi)(shi)還會定(ding)(ding)期對(dui)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)進行審(shen)核(he)，產生“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)評審(shen)記錄(lu)”，來(lai)確(que)認(ren)(ren)(ren)相關(guan)內(nei)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)是(shi)(shi)(shi)否需(xu)(xu)要修訂(ding)。如果有修訂(ding)需(xu)(xu)求，相關(guan)人員(yuan)填(tian)(tian)寫“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)修訂(ding)申(shen)請”，經過(guo)(guo)審(shen)核(he)、批(pi)準(zhun)，方(fang)可(ke)進行修訂(ding)。審(shen)核(he)人和(he)(he)批(pi)準(zhun)人必須是(shi)(shi)(shi)原文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)編(bian)(bian)寫時(shi)審(shen)核(he)批(pi)準(zhun)的(de)(de)(de)崗(gang)位。對(dui)于外(wai)部文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)，一(yi)般通過(guo)(guo)查新來(lai)確(que)認(ren)(ren)(ren)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)的(de)(de)(de)最新有效(xiao)，填(tian)(tian)寫“標準(zhun)有效(xiao)性確(que)認(ren)(ren)(ren)記錄(lu)”。當(dang)實(shi)驗室(shi)(shi)發(fa)放(fang)(fang)的(de)(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)數(shu)量較少(shao)時(shi)，可(ke)通過(guo)(guo)借閱(yue)、復(fu)印(yin)等方(fang)式(shi)獲取(qu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)內(nei)容，借閱(yue)復(fu)印(yin)時(shi)應填(tian)(tian)寫“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)借閱(yue)復(fu)印(yin)登記表”。
 

　　隨(sui)著科(ke)技的(de)(de)(de)(de)飛速發(fa)展，越(yue)來越(yue)多(duo)的(de)(de)(de)(de)實(shi)驗室(shi)(shi)(shi)將(jiang)LIMS系統引入到實(shi)驗室(shi)(shi)(shi)日(ri)常管理(li)當中。文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)控制(zhi)也逐漸被(bei)融(rong)合進來，但(dan)本文(wen)(wen)(wen)(wen)(wen)僅(jin)(jin)就現(xian)階段大多(duo)數實(shi)驗室(shi)(shi)(shi)如何(he)管理(li)文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)進行(xing)簡單的(de)(de)(de)(de)闡述。目前(qian)電子文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)僅(jin)(jin)僅(jin)(jin)是作為紙(zhi)質版(ban)文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)輔助工(gong)具(ju)，以PDF格式發(fa)布(bu)在(zai)各檢測機構或其母體的(de)(de)(de)(de)網絡公示平臺上，共有權(quan)限的(de)(de)(de)(de)人進行(xing)學習(無法(fa)下載和修改)，同時(shi)實(shi)驗室(shi)(shi)(shi)會制(zhi)定一(yi)名(ming)專人負責電子文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)更新替(ti)換(huan)。電子文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)管理(li)按照紙(zhi)質版(ban)文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)要求進行(xing)管理(li)。文(wen)(wen)(wen)(wen)(wen)件(jian)(jian)的(de)(de)(de)(de)控制(zhi)是實(shi)驗室(shi)(shi)(shi)認可的(de)(de)(de)(de)基(ji)礎(chu)，文(wen)(wen)(wen)(wen)(wen)控工(gong)作同時(shi)也是一(yi)個繁瑣(suo)的(de)(de)(de)(de)工(gong)作，可謂牽(qian)一(yi)發(fa)而動(dong)全身，因此在(zai)日(ri)常工(gong)作中安排的(de)(de)(de)(de)人員應耐心、細致(zhi)。

　　本文針對文件(jian)如(ru)何管理，以記錄的形式(shi)向廣大(da)讀(du)者進(jin)行了(le)闡述(shu)，這(zhe)種形式(shi)我個人覺得比較直觀，如(ru)有(you)不(bu)妥可進(jin)行互動交(jiao)流與溝通。

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