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)什么這么說呢，首先我們來看看CNAS-CL01《檢(jian)測和校準(zhun)實(shi)驗室(shi)能力認可(ke)(ke)準(zhun)則(ze)》。準(zhun)則(ze)中4.2.1“應將(jiang)其政(zheng)策、制度、計劃、程序和指導書制訂成(cheng)文件”，隨后(hou)4.3中單獨形(xing)成(cheng)一(yi)個(ge)章(zhang)節(jie)“文件控制”。可(ke)(ke)見文件的(de)控制在準(zhun)則(ze)中所占(zhan)比重(zhong)還是(shi)相當大的(de)，做(zuo)好(hao)文控工作是(shi)申報實(shi)驗室(shi)認可(ke)(ke)的(de)基礎。

　　如何做(zuo)好文(wen)控工作呢?首先應(ying)該明確文(wen)件(jian)的概(gai)念(nian)。文(wen)件(jian)是(shi)以(yi)文(wen)字或圖示描述管理內容或業務內容、通過規定程序由有權人(ren)員(yuan)簽署發布、要(yao)求接收(shou)者據此做(zuo)出規范反(fan)應(ying)的電子(zi)(zi)文(wen)檔或紙質文(wen)檔。一般形式為(wei)硬(ying)拷貝類(lei)和電子(zi)(zi)類(lei)。硬(ying)拷貝就是(shi)大(da)家常見的紙質版文(wen)件(jian)，電子(zi)(zi)版一般體現為(wei)PDF和WORD形式。

　　為了(le)便于(yu)識(shi)別，通常(chang)會賦予文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)一(yi)個(ge)唯(wei)一(yi)性(xing)編(bian)號，各個(ge)實驗室(shi)(shi)在進(jin)(jin)行編(bian)號時(shi)，可(ke)(ke)結合公司(si)(si)的(de)(de)企業(ye)文(wen)(wen)(wen)(wen)(wen)(wen)化，將公司(si)(si)的(de)(de)縮寫(xie)、LOGO融入編(bian)號規則當(dang)中。對(dui)(dui)于(yu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)的(de)(de)管理(li)首先應該(gai)確(que)定(ding)一(yi)個(ge)范圍，一(yi)般(ban)以“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)控(kong)制(zhi)清單”來(lai)體現(xian)。清單內(nei)的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)根(gen)據(ju)其來(lai)源(yuan)可(ke)(ke)分為外部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)和(he)內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)，顧名思義，內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)就是(shi)實驗室(shi)(shi)自己編(bian)寫(xie)的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)，外部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)是(shi)實驗室(shi)(shi)為了(le)滿(man)足(zu)自身需(xu)求(qiu)而(er)(er)引用(yong)(yong)的(de)(de)相(xiang)關(guan)(guan)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)，包括認(ren)(ren)可(ke)(ke)委準(zhun)(zhun)則、規則、指南、檢測(ce)用(yong)(yong)的(de)(de)標(biao)(biao)準(zhun)(zhun)方法以及(ji)參(can)考書籍(ji)等。確(que)認(ren)(ren)了(le)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)的(de)(de)管理(li)范圍，接下來(lai)就要將文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)“傳達至有(you)(you)關(guan)(guan)人(ren)(ren)(ren)員(yuan)”，被其“理(li)解、獲取和(he)執行”。一(yi)般(ban)通過(guo)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)發(fa)放(fang)回(hui)收記錄”來(lai)體現(xian)。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)的(de)(de)發(fa)放(fang)類(lei)型(xing)及(ji)份數需(xu)要根(gen)據(ju)實驗室(shi)(shi)需(xu)求(qiu)而(er)(er)定(ding)，例(li)如(ru)(ru)體系(xi)(xi)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)需(xu)要全體人(ren)(ren)(ren)員(yuan)進(jin)(jin)行學(xue)習使用(yong)(yong)，而(er)(er)檢測(ce)標(biao)(biao)準(zhun)(zhun)則僅(jin)僅(jin)針對(dui)(dui)于(yu)檢測(ce)人(ren)(ren)(ren)員(yuan)，因此發(fa)放(fang)份數肯定(ding)是(shi)不同的(de)(de)。文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)在使用(yong)(yong)過(guo)程(cheng)中，相(xiang)關(guan)(guan)人(ren)(ren)(ren)員(yuan)會對(dui)(dui)其適(shi)用(yong)(yong)性(xing)提(ti)出質(zhi)疑，這也是(shi)體系(xi)(xi)持續改進(jin)(jin)的(de)(de)一(yi)種表現(xian)形式(shi)。內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)實驗室(shi)(shi)人(ren)(ren)(ren)員(yuan)在日(ri)常(chang)使用(yong)(yong)過(guo)程(cheng)中可(ke)(ke)隨時(shi)提(ti)出文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)的(de)(de)修訂(ding)(ding)申請，而(er)(er)實驗室(shi)(shi)還會定(ding)期對(dui)(dui)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)進(jin)(jin)行審(shen)(shen)核(he)，產生(sheng)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)評審(shen)(shen)記錄”，來(lai)確(que)認(ren)(ren)相(xiang)關(guan)(guan)內(nei)部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)是(shi)否(fou)需(xu)要修訂(ding)(ding)。如(ru)(ru)果有(you)(you)修訂(ding)(ding)需(xu)求(qiu)，相(xiang)關(guan)(guan)人(ren)(ren)(ren)員(yuan)填寫(xie)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)修訂(ding)(ding)申請”，經過(guo)審(shen)(shen)核(he)、批(pi)(pi)準(zhun)(zhun)，方可(ke)(ke)進(jin)(jin)行修訂(ding)(ding)。審(shen)(shen)核(he)人(ren)(ren)(ren)和(he)批(pi)(pi)準(zhun)(zhun)人(ren)(ren)(ren)必須是(shi)原文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)編(bian)寫(xie)時(shi)審(shen)(shen)核(he)批(pi)(pi)準(zhun)(zhun)的(de)(de)崗位(wei)。對(dui)(dui)于(yu)外部(bu)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)，一(yi)般(ban)通過(guo)查新(xin)來(lai)確(que)認(ren)(ren)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)的(de)(de)最新(xin)有(you)(you)效，填寫(xie)“標(biao)(biao)準(zhun)(zhun)有(you)(you)效性(xing)確(que)認(ren)(ren)記錄”。當(dang)實驗室(shi)(shi)發(fa)放(fang)的(de)(de)文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)數量較(jiao)少時(shi)，可(ke)(ke)通過(guo)借(jie)閱(yue)、復印等方式(shi)獲取文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)內(nei)容，借(jie)閱(yue)復印時(shi)應填寫(xie)“文(wen)(wen)(wen)(wen)(wen)(wen)件(jian)(jian)(jian)(jian)(jian)(jian)(jian)(jian)借(jie)閱(yue)復印登記表”。
 

　　隨著科(ke)技(ji)的(de)(de)(de)飛速發展(zhan)，越(yue)(yue)來越(yue)(yue)多的(de)(de)(de)實(shi)(shi)驗室(shi)將LIMS系統(tong)引入到實(shi)(shi)驗室(shi)日常管理(li)當中。文(wen)件的(de)(de)(de)控制(zhi)(zhi)也逐(zhu)漸被(bei)融(rong)合進來，但本文(wen)僅就現(xian)階段(duan)大多數實(shi)(shi)驗室(shi)如(ru)何(he)管理(li)文(wen)件進行簡單的(de)(de)(de)闡(chan)述(shu)。目前電(dian)子文(wen)件僅僅是作(zuo)為紙(zhi)質版文(wen)件的(de)(de)(de)輔助工(gong)具，以PDF格式發布在各(ge)檢測機構(gou)或其母體的(de)(de)(de)網絡公示平臺上，共(gong)有權限(xian)的(de)(de)(de)人(ren)進行學(xue)習(無法(fa)下載和修改)，同時實(shi)(shi)驗室(shi)會制(zhi)(zhi)定一(yi)(yi)名專人(ren)負責電(dian)子文(wen)件的(de)(de)(de)更新替換。電(dian)子文(wen)件的(de)(de)(de)管理(li)按照紙(zhi)質版文(wen)件的(de)(de)(de)要求進行管理(li)。文(wen)件的(de)(de)(de)控制(zhi)(zhi)是實(shi)(shi)驗室(shi)認可的(de)(de)(de)基礎(chu)，文(wen)控工(gong)作(zuo)同時也是一(yi)(yi)個繁(fan)瑣的(de)(de)(de)工(gong)作(zuo)，可謂牽(qian)一(yi)(yi)發而動全身，因(yin)此在日常工(gong)作(zuo)中安排(pai)的(de)(de)(de)人(ren)員應耐心、細致。

　　本文針對文件如何管理(li)，以記(ji)錄的形式向廣大(da)讀者進行了闡述，這種形式我個人覺(jue)得(de)比較直觀，如有不妥可進行互(hu)動交流與溝(gou)通。

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