【正文】 ess有程序來保護(hù)和備份以電子形式存儲(chǔ)的記錄，防止未經(jīng)授權(quán)的侵入48169。preventandbackupprotectproceduresandheldshallestablished規(guī)定保存時(shí)間? Allshallsuitableinreadilyretainedlegible,shallcorrective preventive actions質(zhì)量記錄包括內(nèi)審管理評(píng)審和糾正措施? Allrecordsreportsincluderecords應(yīng)建立并維持識(shí)別、收集、索引、存取、存檔、存放、維護(hù)和清理質(zhì)量記錄和技術(shù)記錄的程序? Qualityandofandstorage,access,collection,for Copy Right Reserved by ULCCIC Company Limited IEC－ 4 ,糾 正 與預(yù) 防措施的步 驟 (8D)D1 :成立 問題處 理小 組D2 : 問題 描 述D3 : 采 取 臨時(shí) 的 圍 堵措施D4 : 真因分析D5 : 采 取永久的 糾 正措施D6 : 執(zhí)行并確認(rèn)糾正措施D7 : 防止再 發(fā)生 (預(yù)防措施 )D8 : 肯定 團(tuán)隊(duì) 和 個(gè) 人表 現(xiàn)47169。1211109841 Copy Right Reserved by ULCCIC Company Limited IEC－ 4 ,趨勢圖與 預(yù)防措施月份 通常 需要 糾正對(duì) 策216。 通常為單 一事件216。 被 動(dòng) 的 (Reactive)216。糾正216。results涉及數(shù)據(jù)分析 ,包括趨勢（ SPC） 和風(fēng)險(xiǎn)水平和水平測試結(jié)果的分析44169。andrisktrenddata,analysismighteffective確保預(yù)防措施有效? Preventiveactionstheensureaction)事先對(duì)事后? Procedurevs.theadvantage Tofrom Toispreventiveplansmonitorimplement43169。ISOprocedures,policieswithnotnonconformance39。accordanceareasatdoneshallbeentakencorrectivethattotheactions文件化并執(zhí)行任何需要的變更42169。fromchangesimplement Documenttheriskandthe Appropriatecorrectiveactions糾正措施的選擇和執(zhí)行– Identifyofandtheroot causesaction制定實(shí)施糾正措施的政策和程序? Determineforappropriateandand Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Corrective Action(I)糾正措施 I? Establish Managementpreventive Correctiveofresults216。objectives216。policy216。 usethroughmanagementofthecontinuallylaboratoryrecur不合格工作重復(fù)發(fā)生應(yīng)立即運(yùn)行 40169。workthefollowedbegivenchecks人員監(jiān)督管理 /文件檢查? Corrective actionor Staff(.Qualityresults管理評(píng)審216。review顧客投訴 audits,plaints, Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Control of Nonconforming Testing and/or Calibration Work(II)不符合檢測和校準(zhǔn)工作的控制 II? Examples:isresumptionauthorizing Responsibilitywhereisandisimmediately立即采取糾正措施216。are Remedial actionsisnonconformingofthedesignated確定對(duì)不符合工作進(jìn)行管理的責(zé)任和權(quán)力 , 確定所采取的措施216。workoftheauthorities Responsibilitiesensuredeviations Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Control of Nonconforming Testing and/or Calibration Work(I) 不符合檢測和校準(zhǔn)工作的控制 I? Policy and proceduresactions Investigations調(diào)查216。maintained:保持記錄216。shallpliantprocedure Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Complaints報(bào)怨? Policy Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Service to the Client服務(wù)顧客? 應(yīng)理解并明確客戶要求? 合理準(zhǔn)許客戶 到現(xiàn)場監(jiān)督開展定期的客戶調(diào)查是簡便有效的方法... OFFER A SMILE.fromnegative(positive Client Communicationcalibrationtestdispatchpackaging,witness見證216。areasto Reasonablemayotherconfidentialityperformance監(jiān)視其工作有關(guān)的操作216。 Monitorclient’scooperation Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Service to the Client服務(wù)顧客? AffordbeList)(Approvedmaintained保存這些評(píng)價(jià)的記錄216。shall Records ofandcriticalsuppliers Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Purchasing Services and Supplies服務(wù)和供應(yīng)品的采購 IIq Evaluationbe Recordswith Prior to use使用前216。materials:servicesofortotechnical contentapprovedreviewedshallmaterials采購接受儲(chǔ)存試劑和易耗品q Purchasingandofand Purchase,and Selection ofprocedures Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Purchasing Services and Supplies服務(wù)和供應(yīng)品的采購 Iq Policyallregisterspecifies實(shí)驗(yàn)室就其分包方的工作對(duì)客戶負(fù)責(zé)v Maintainregulatoryclientwork,subcontractor’sfortheresponsibleappropriate獲得客戶的批準(zhǔn)v Laboratoryapprovalandintheaplacedarrangements)長期連續(xù)情況下? shallorsubcontracting,throughincapacity)不可預(yù)見原因? Continuing basisorfurtherneed(.ofpersonnel變更情況應(yīng)評(píng)審并通知所有受影響的人員32169。allmunicatedreviewedshalltothedeviationofbemaintained保持評(píng)審記錄包括重大變化的記錄v ClientshallwithandsignificantReview of Requests, Tenders and Contracts要求、標(biāo)書和合同的評(píng)審 IIv Records of review,reviewed審查所有被分包的工作31169。shallresolved工作開始前，已解決差異216。shallandbetweencapable選擇適當(dāng)?shù)臋z測和校準(zhǔn)方法216。selectedtest and/or calibration methodrequirements能力和資源216。meetCapability and resourcesanddefined,that:建立和維持評(píng)審客戶要求，標(biāo)書和合同的程序216。shallcontractReview of Requests, Tenders and Contracts要求、標(biāo)書和合同的評(píng)審 Iv Procedures電子版文件更改的程序30169。establishedshalltofor手改應(yīng)清楚標(biāo)記簽名和注明日期216。datedinitialedbeamendments Handbehand written amendmentsauthorities Proceduresbetext)or Changesauthorizedapprovedbe Changesissuingpagesnumbernumbering,issue/revision,(datebe Documentssuitablyshallpreservationor(forobsolete Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Document Control (II)文件控制 II216。 Copy Right Reserved by ULCCIC Company Limited IEC－ 4 ,文件的價(jià)值文件可以溝通意圖、統(tǒng)一行動(dòng)，有助于：? 實(shí)現(xiàn)產(chǎn)品質(zhì)量和質(zhì)量改進(jìn)；? 提供適宜的培訓(xùn)；? 確保重復(fù)性和可追溯性；? 提供客觀的證據(jù)；? 評(píng)價(jià)體系的有效性。unintendedassurepromptly,ofallremovedshall Invalid/obsoleteasandperiodicallyshalluse適當(dāng)?shù)氖跈?quán)版本216。pointavailableshall Authorizeddistributioncurrent revisiontobeprocedureequivalent Master listtoapprovedreviewedshall Allmanualsandsoftware,methods,standards,be External documentsinternal/externaltomaintain Establishdefined規(guī)定技術(shù)質(zhì)量經(jīng)理的職責(zé)27169。shall Duties ofthereferenceorsystem概述質(zhì)量體系文件結(jié)構(gòu)216。theusedthedefined定義方針目標(biāo)216。shalland Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Quality System (II)質(zhì)量體系 IIq Quality Manual質(zhì)量手冊(cè)216。 Copy Right Reserved by ULCCIC Company Limited IEC－ 4 ,訂定目標(biāo)的原則 SMART? 特定性 (Specific)? 可衡量 (Measurable)? 可達(dá)成性 . 有挑戰(zhàn)性 (Attainable)? 相關(guān)性 (Relevant)? 時(shí)限性 (Timeframe)上司的支持與承諾，以及員工的認(rèn)同是達(dá)成目標(biāo)的關(guān)鍵因素?。?5169。 客戶滿意度高于 80分216。 延誤報(bào)告交期 不超 過 1天216。(僅 供 參 考 )? 實(shí)驗(yàn) 室 質(zhì)量方針– 以 優(yōu) 良的 測試 品 質(zhì) 提供客戶最佳的滿意 服務(wù)? 實(shí)驗(yàn) 室 質(zhì)量 目 標(biāo)216。1702523169。ISOpliance CommitmentallImplementationUnderstandingsystem確定目標(biāo)216。the Objectivesofservice承諾為客戶服務(wù)的良好職業(yè)操守216。andgood CommitmenttheatChief Executive,authorizedQuality Manual在質(zhì)量手冊(cè)中規(guī)定質(zhì)量方針和目標(biāo)v Quality PolicyinbeobjectivesPoliciesandsystem,itsitsscopetosystemaand Copy Right Reserved by ULCCIC Company Limited IEC－ 4 , Quality