ISO17025_培訓(xùn)教材

1、 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 1 檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求修訂：ISO/IEC 17025 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 2講師介紹 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 3學(xué)員自我介紹學(xué)員自我介紹姓名姓名職務(wù)職務(wù)參加本次課程的目的參加本次課程的目的期望期望 Copy Right

2、Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 4Day 1 Agenda第1天日程表 Introduction to ISO/IEC 17025:2005 標(biāo)準(zhǔn)介紹 質(zhì)量管理八大原則介紹 Management requirement管理要求 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 5Day 2 Agenda 第2天日程表Process approach -Laboratory Audit 過(guò)程方法實(shí)驗(yàn)室審核Technical requirement技術(shù)

3、要求 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 6Day 3 Agenda 第3天日程表Technical requirement技術(shù)要求Introduction to Uncertainty of Measurement測(cè)量不確定度介紹Exam 考試 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 7 練習(xí)練習(xí)1 1 請(qǐng)列舉你認(rèn)為一個(gè)請(qǐng)列舉你認(rèn)為一個(gè)好的校好的校準(zhǔn)準(zhǔn)或或檢測(cè)實(shí)驗(yàn)檢測(cè)實(shí)驗(yàn)室室應(yīng)應(yīng)具具備備哪些哪些條件條件或或特色，以符合

4、客戶的要求特色，以符合客戶的要求并使客戶滿意并使客戶滿意。(使用時(shí)間使用時(shí)間：10分分鐘鐘)請(qǐng)請(qǐng)各各組討論后組討論后，派一名代表上臺(tái)，派一名代表上臺(tái)發(fā)發(fā)表。表。 (各各組組使用使用時(shí)間時(shí)間: : 3 分分鐘鐘以內(nèi)以內(nèi))ISO/IEC 17025 標(biāo)準(zhǔn)介紹標(biāo)準(zhǔn)介紹 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 8 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 9ISO/IEC17025ISO/IEC17025的制定目標(biāo)的制定目標(biāo)證明其按管

5、理體系運(yùn)行、具有技術(shù)能力并能提供正確證明其按管理體系運(yùn)行、具有技術(shù)能力并能提供正確的技術(shù)結(jié)果所必須滿足的所有要求的技術(shù)結(jié)果所必須滿足的所有要求主要適用實(shí)驗(yàn)室，也必須可用作認(rèn)可準(zhǔn)則主要適用實(shí)驗(yàn)室，也必須可用作認(rèn)可準(zhǔn)則必須代替必須代替EN45001EN45001，達(dá)成國(guó)際上的統(tǒng)一達(dá)成國(guó)際上的統(tǒng)一必須明確與必須明確與ISO9000ISO9000的關(guān)系的關(guān)系作為國(guó)際標(biāo)準(zhǔn)出版作為國(guó)際標(biāo)準(zhǔn)出版擴(kuò)大范圍，納入抽樣、新方法制定和專業(yè)判斷內(nèi)容擴(kuò)大范圍，納入抽樣、新方法制定和專業(yè)判斷內(nèi)容將管理要求和技術(shù)要求分離，利于使用將管理要求和技術(shù)要求分離，利于使用更具靈活性更具靈活性更關(guān)注電子手段的應(yīng)用更關(guān)注電子手段的應(yīng)用

6、避免制定過(guò)多應(yīng)用或解釋性文件避免制定過(guò)多應(yīng)用或解釋性文件 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 10ISO/IEC17025ISO/IEC17025新舊版的顯著區(qū)別新舊版的顯著區(qū)別增加了適用性條款增加了適用性條款強(qiáng)調(diào)了管理強(qiáng)調(diào)了管理更關(guān)注顧客更關(guān)注顧客規(guī)定了質(zhì)量方針聲明的最基本內(nèi)容規(guī)定了質(zhì)量方針聲明的最基本內(nèi)容擴(kuò)大了合同評(píng)審內(nèi)容擴(kuò)大了合同評(píng)審內(nèi)容新增加了糾正措施章節(jié)新增加了糾正措施章節(jié) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Pag

7、e 11(接上頁(yè)) 新增加了預(yù)防措施章節(jié)新增加了預(yù)防措施章節(jié) 新增加了持續(xù)改進(jìn)章節(jié)（新增加了持續(xù)改進(jìn)章節(jié)（20052005版本）版本） 增加了管理評(píng)審過(guò)程中應(yīng)包括的內(nèi)容增加了管理評(píng)審過(guò)程中應(yīng)包括的內(nèi)容 增加了新方法制定要求，規(guī)定了有效性（確認(rèn)）的準(zhǔn)則增加了新方法制定要求，規(guī)定了有效性（確認(rèn)）的準(zhǔn)則 強(qiáng)化了對(duì)測(cè)量不確定度要求強(qiáng)化了對(duì)測(cè)量不確定度要求 區(qū)分開校準(zhǔn)和檢測(cè)實(shí)驗(yàn)室的量值溯源性區(qū)分開校準(zhǔn)和檢測(cè)實(shí)驗(yàn)室的量值溯源性 結(jié)果報(bào)告增加了很多內(nèi)容結(jié)果報(bào)告增加了很多內(nèi)容ISO/IEC17025ISO/IEC17025新舊版的顯著區(qū)別新舊版的顯著區(qū)別 Copy Right Reserved by UL-C

8、CIC Company LimitedIEC4 ,Rev.01Page 12Biological (生物生物)Mechanical (機(jī)械機(jī)械性性)Acoustical & Vibration (聲學(xué)與振動(dòng)聲學(xué)與振動(dòng))Non-destructive (非非破壞破壞性性)Chemical (化化學(xué)學(xué))Environmental (環(huán)環(huán)境境)Construction Materials (結(jié)構(gòu)結(jié)構(gòu)材料材料)Electrical (電學(xué)電學(xué))Thermal (熱熱)Calibration (校正校正) Copy Right Reserved by UL-CCIC Company Limite

9、dIEC4 ,Rev.01Page 13ISO/IEC17025:2005ISO/IEC17025:2005包含了包含了ISO 9001中與實(shí)驗(yàn)室管理中與實(shí)驗(yàn)室管理體系所覆蓋的檢測(cè)和校準(zhǔn)服務(wù)有關(guān)的所有要求體系所覆蓋的檢測(cè)和校準(zhǔn)服務(wù)有關(guān)的所有要求實(shí)驗(yàn)室質(zhì)量管理體系符合實(shí)驗(yàn)室質(zhì)量管理體系符合ISO 9001的要求，并不證明的要求，并不證明實(shí)驗(yàn)室具有出具技術(shù)上有效數(shù)據(jù)和結(jié)果的能力實(shí)驗(yàn)室具有出具技術(shù)上有效數(shù)據(jù)和結(jié)果的能力實(shí)驗(yàn)室質(zhì)量管理體系符合本準(zhǔn)則，也不意味其運(yùn)作符實(shí)驗(yàn)室質(zhì)量管理體系符合本準(zhǔn)則，也不意味其運(yùn)作符合合ISO 9001的所有要求。的所有要求。 Copy Right Reserved by

10、UL-CCIC Company LimitedIEC4 ,Rev.01Page 14nScope范圍nNormative References參考標(biāo)準(zhǔn)nTerms and Definitions名詞與定義nManagement Requirements 管理要求nTechnical Requirements 技術(shù)要求ISO/IEC 17025規(guī)范的架構(gòu) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 15范圍制定執(zhí)行測(cè)試與校正的一般能力要求， 包括取樣涵蓋了使用標(biāo)準(zhǔn)標(biāo)準(zhǔn)、非非標(biāo)準(zhǔn)實(shí)驗(yàn)標(biāo)準(zhǔn)實(shí)驗(yàn)室自行室自行開發(fā)開發(fā)之方法

11、 所執(zhí)行的測(cè)試與校正適用于所有的實(shí)驗(yàn)實(shí)驗(yàn)室，而與實(shí)驗(yàn)實(shí)驗(yàn)室的人數(shù)和所執(zhí)行的測(cè)試與校正的范圍無(wú)關(guān)本準(zhǔn)則中的注是對(duì)正文的說(shuō)明、舉例和指導(dǎo)。它們既不包含要求，也不構(gòu)成本準(zhǔn)則的主體部分本準(zhǔn)則是CNAS對(duì)檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力進(jìn)行認(rèn)可的依據(jù)，也可用于實(shí)驗(yàn)室建立管理體系，以及為實(shí)驗(yàn)室的客戶、法定管理機(jī)構(gòu)對(duì)實(shí)驗(yàn)室的能力進(jìn)行確認(rèn)或承認(rèn)提供指南不涵蓋實(shí)驗(yàn)實(shí)驗(yàn)室作業(yè)的相關(guān)法規(guī)與安全要求ISO/IEC 17025 標(biāo)準(zhǔn)介紹標(biāo)準(zhǔn)介紹 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 16質(zhì)量質(zhì)量管理八大原管理八大原則則 顧客導(dǎo)向 (Custom

12、er Focus) 領(lǐng)導(dǎo)作用 (Leadership) 全員參與 (Involvement of People) 系統(tǒng)性管理 (System Approach to Management) 流程導(dǎo)向 (Process Approach) 持續(xù)改善 (Continual Improvement) 基于事實(shí)的決策 ( Factual Approach to Decision Making) 互利(雙贏)的供應(yīng)鏈關(guān)系 ( Mutually Beneficial Supplier Relationship) Copy Right Reserved by UL-CCIC Company LimitedI

13、EC4 ,Rev.01Page 17安全與健康（安全與健康（1.51.5） 任何國(guó)家的認(rèn)可活動(dòng)，都是以符合該國(guó)的安全與健康相關(guān)法律任何國(guó)家的認(rèn)可活動(dòng)，都是以符合該國(guó)的安全與健康相關(guān)法律/ /法規(guī)為前提的法規(guī)為前提的 實(shí)驗(yàn)室的活動(dòng)，也應(yīng)以遵守實(shí)驗(yàn)室的活動(dòng)，也應(yīng)以遵守 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 18Management Requirements 管理要求管理要求4.1 Organization組織組織組織4.2 Quality System質(zhì)量體系質(zhì)量體系4.3 Document Control文控

14、文控4.4 Review of Requests, Tenders and Contracts合同評(píng)審合同評(píng)審4.5 Subcontracting of Tests and Calibrations檢測(cè)和校準(zhǔn)的分包檢測(cè)和校準(zhǔn)的分包4.6 Purchasing Services and Supplies服服務(wù)和供應(yīng)品的采購(gòu)務(wù)和供應(yīng)品的采購(gòu)4.7 Service to the Client服務(wù)客戶服務(wù)客戶4.8 Complaints抱怨抱怨4.9 Control of Nonconforming Testing and/or Calibration Work不合格檢測(cè)和校準(zhǔn)的控制不合格檢測(cè)和校準(zhǔn)的

15、控制4.10 Improvement 改進(jìn)改進(jìn)4.11 Corrective Action糾正措施糾正措施4.12 Preventive Action預(yù)防措施預(yù)防措施4.13 Control of Records紀(jì)錄控制紀(jì)錄控制4.14 Internal Audits內(nèi)審內(nèi)審4.15 Management Reviews管理評(píng)審管理評(píng)審 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 194.1 Organization (I)組織組織ILegally responsible法律實(shí)體Meet Standard, Cu

16、stomer, Regulatory & Accreditation Bodies Requirements滿足標(biāo)準(zhǔn) 客戶 法規(guī) 和認(rèn)可機(jī)構(gòu)的要求Cover work carried out in permanent, offsite,mobile or temporary facilities覆蓋固定 外部 移動(dòng)或臨時(shí)場(chǎng)所Other activities/responsibilities influencing lab work shall be defined in order to identify potential conflicts of interest 明確責(zé)任以鑒別潛

17、在的利益沖突 Other functions (e.g. Sales, Production or Finance etc.)其他職能 Independence of third party laboratories三方實(shí)驗(yàn)室的獨(dú)立性 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 204.1 Organization (II)組織組織IIThe laboratory shall實(shí)驗(yàn)室應(yīng)a) Have managerial and technical personnel with authority and reso

18、urces to carry out their duties擁有所需權(quán)力和資源的管理人員和技術(shù)人員b) Ensure management and personnel are free from any undue pressure (commercial or financial etc.)識(shí)別偏離c) Have policies and procedures for protection of clients confidential information and proprietary rights方針和程序確保機(jī)密信息和所有權(quán)的保護(hù)d) Have policies and proc

19、edures to protect competence, impartiality and judgment or operational integrity方針和程序避免有損能力 公正 判斷能力 誠(chéng)實(shí)性 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 214.1 Organization (III)組織組織IIIe) Define the organization structure, its place in parent organization and relationships between labor

20、atory and support services確定組織機(jī)構(gòu)和母體與支持服務(wù)的關(guān)系f) Specify the responsibilities, authorities and interrelationships of all personnel規(guī)定責(zé)任 權(quán)限和相互關(guān)系g) Provide adequate supervision of testing and calibration staff對(duì)測(cè)試和校準(zhǔn)人員實(shí)施適當(dāng)監(jiān)督h) Have technical management responsible for the technical operations技術(shù)管理者i) Appoin

21、t a Quality Manager ( however named) who can direct access to the highest level of management質(zhì)量經(jīng)理j) Appoint deputies for key managerial personnel代理人 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 22關(guān)鍵人員（關(guān)鍵人員（4.1.44.1.4）關(guān)鍵人員的范圍一般至少含關(guān)鍵人員的范圍一般至少含：首席執(zhí)行官（首席執(zhí)行官（CEOCEO）技術(shù)主管、授權(quán)簽字人技術(shù)主管、授權(quán)簽字人質(zhì)

22、量主管質(zhì)量主管 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 234.2 Quality System (I)質(zhì)量體系IvEstablish, Implement, and Maintain a quality system appropriate to the scope of its activities建立、實(shí)施和維持與其活動(dòng)范圍相適應(yīng)的質(zhì)量體系vDocument its policies, system, procedures and instructions文件化政策、制度、計(jì)劃、程序和指導(dǎo)書等等v Po

23、licies and objectives shall be defined in the Quality Manual在質(zhì)量手冊(cè)中規(guī)定質(zhì)量方針和目標(biāo)vQuality Policy statement authorized by Chief Executive, include at least the following:主要管理者發(fā)布批準(zhǔn)質(zhì)量方針: Commitment to good practice and client service承諾為客戶服務(wù)的良好職業(yè)操守 Standard of service實(shí)驗(yàn)室服務(wù)標(biāo)準(zhǔn)的聲明 Objectives of the quality syste

24、m確定目標(biāo) Familiarity, Understanding and Implementation by all personnel為全員認(rèn)知 Commitment to compliance with ISO 17025承諾符合ISO 17025 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 24質(zhì)量方針與質(zhì)量質(zhì)量方針與質(zhì)量目目標(biāo)舉標(biāo)舉例例 (僅供參考) 實(shí)驗(yàn)實(shí)驗(yàn)室室質(zhì)量方針質(zhì)量方針 以優(yōu)良的測(cè)試品質(zhì)提供客戶最佳的滿意服務(wù) 實(shí)驗(yàn)實(shí)驗(yàn)室室質(zhì)量質(zhì)量目目標(biāo)標(biāo) 每月客訴件數(shù)不超過(guò)2件 延誤報(bào)告交期不超過(guò) 1天 報(bào)告出

25、錯(cuò)率小于5% 客戶滿意度高于80分 2005年取得ISO/IEC 17025的證書 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 25訂定目標(biāo)的原則訂定目標(biāo)的原則- SMART 特定性特定性 (Specific) 可衡量可衡量 (Measurable) 可達(dá)成性可達(dá)成性v.s. 有挑戰(zhàn)性有挑戰(zhàn)性 (Attainable) 相關(guān)性相關(guān)性 (Relevant) 時(shí)限性時(shí)限性 (Timeframe)上司的支持與承諾，以及員工的認(rèn)同是達(dá)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！成目標(biāo)的關(guān)鍵因素！ Copy Ri

26、ght Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 26實(shí)驗(yàn)室的工作范圍實(shí)驗(yàn)室的工作范圍 專業(yè)領(lǐng)域和學(xué)科專業(yè)領(lǐng)域和學(xué)科 校準(zhǔn)領(lǐng)域校準(zhǔn)領(lǐng)域 檢測(cè)領(lǐng)域檢測(cè)領(lǐng)域 實(shí)驗(yàn)室的質(zhì)量體系應(yīng)覆蓋其工作范圍實(shí)驗(yàn)室的質(zhì)量體系應(yīng)覆蓋其工作范圍 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 274.2 Quality System (II)質(zhì)量體系IIq Quality Manual質(zhì)量手冊(cè) Policies and objectives shall be defined定義方針

27、目標(biāo) Outline the structure of the documentation used in the quality system概述質(zhì)量體系文件結(jié)構(gòu) Include or make reference to the supporting & technical procedures引用程序文件 Duties of Technical and Quality Managers shall be defined規(guī)定技術(shù)質(zhì)量經(jīng)理的職責(zé) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 284.3 Do

28、cument Control (I)文件控制Iq General總則總則 Establish and maintain procedures to control internal/external documents建立程序控制外部文件,內(nèi)部文件 External documents may be regulations, standards, test/calibration methods, drawings, software, specifications and instruction manuals etc.外部文件可能包括法規(guī) 標(biāo)準(zhǔn) 測(cè)試校準(zhǔn)方法 圖紙 軟件 規(guī)范和指導(dǎo)書等q

29、Document Approval and Issue文件的批準(zhǔn)和發(fā)布 All documents shall be reviewed and approved prior to issue發(fā)布前的審查和批準(zhǔn) Master list or equivalent control procedure shall be established to identify the current revision and distribution status建立清單 Authorized documents shall be available at point of use適當(dāng)?shù)氖跈?quán)版本 Docume

30、nts shall be periodically reviewed and revised as necessary定期審查文件 Invalid/obsolete documents shall be removed from all points of use promptly, or assure against unintended use撤除作廢文件 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 29文件的價(jià)值文件可以溝通意圖、統(tǒng)一行動(dòng)，有助于：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)

31、；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)；提供適宜的培訓(xùn)； 確保重復(fù)性和可追溯性；確保重復(fù)性和可追溯性； 提供客觀的證據(jù)；提供客觀的證據(jù)； 評(píng)價(jià)體系的有效性。評(píng)價(jià)體系的有效性。 文件的制定應(yīng)是一項(xiàng)文件的制定應(yīng)是一項(xiàng)增值增值的活動(dòng)的活動(dòng) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 304.3 Document Control (II)文件控制II Retained obsolete documents (for legal or knowledge preservation purpose) shall be s

32、uitably marked標(biāo)記保留作廢文件 Documents shall be unique identified (date of issue/revision, page numbering, total number of pages and issuing authority)唯一標(biāo)識(shí)q Document Changes文件更改 Changes shall be reviewed and approved by authorized personnel審批 Changes (altered or new text) shall be identified標(biāo)注更改 Procedure

33、s and authorities for hand written amendments shall be defined手改的程序和權(quán)限 Hand written amendments shall be clearly marked, initialed and dated 手改應(yīng)清楚標(biāo)記簽名和注明日期 Procedure for changes to electronic documents shall be established 電子版文件更改的程序 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 314.

34、4 Review of Requests, Tenders and Contracts要求、標(biāo)書和合同的評(píng)審Iv Procedures for contract review shall ensure that:建立和維持評(píng)審客戶要求，標(biāo)書和合同的程序 Requirements are defined, documented and understood要求被適當(dāng)?shù)匾?guī)定，形成文件，被理解 Capability and resources to meet the requirements能力和資源 Appropriate test and/or calibration method is sel

35、ected and capable選擇適當(dāng)?shù)臋z測(cè)和校準(zhǔn)方法 Differences between tender and contract shall be resolved工作開始前，已解決差異 Subcontracted work shall be reviewed審查所有被分包的工作 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 324.4 Review of Requests, Tenders and Contracts要求、標(biāo)書和合同的評(píng)審IIv Records of review, including

36、significant changes and discussions with client, shall be maintained保持評(píng)審記錄包括重大變化的記錄v Client shall be informed of any deviation from the contract對(duì)合同的任何偏離均應(yīng)通知客戶v Changes to contract shall be reviewed and communicated to all affected personnel變更情況應(yīng)評(píng)審并通知所有受影響的人員 Copy Right Reserved by UL-CCIC Company Li

37、mitedIEC4 ,Rev.01Page 334.5 Subcontracting of Tests and Calibrations檢測(cè)和校準(zhǔn)的分包v Subcontracting of work:工作的分包 Unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity)不可預(yù)見原因 Continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements)長(zhǎng)期連續(xù)情況下

38、shall be placed with a competent subcontractor應(yīng)分包給合格的分包方v Advise the client in writing and gain approval when appropriate獲得客戶的批準(zhǔn)v Laboratory is responsible to the client for the subcontractors work, except client or regulatory authority specifies實(shí)驗(yàn)室就其分包方的工作對(duì)客戶負(fù)責(zé)v Maintain a register of all subcontra

39、ctors保存所有分包方的注冊(cè)資料 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 344.6 Purchasing Services and Supplies服務(wù)和供應(yīng)品的采購(gòu)Iq Policy and procedures for擁有的政策和程序 Selection of services and supplies選擇和購(gòu)買的服務(wù)和供應(yīng)品 Purchase, reception and storage of reagent and consumable materials采購(gòu)接受儲(chǔ)存試劑和易耗品q Purchas

40、ing documents shall be reviewed and approved for technical content prior to release采購(gòu)文件在發(fā)出之前,其技術(shù)內(nèi)容應(yīng)經(jīng)過(guò)審查和批準(zhǔn)q Inspection or verification of purchased services or materials: 檢查驗(yàn)證購(gòu)買的服務(wù)和供應(yīng)品 Prior to use使用前使用前 Compliance with specified requirements符合要求符合要求 Records shall be maintained保持記錄 Copy Right Reserv

41、ed by UL-CCIC Company LimitedIEC4 ,Rev.01Page 354.6 Purchasing Services and Supplies服務(wù)和供應(yīng)品的采購(gòu)IIq Evaluation of suppliers for critical consumables and services:評(píng)價(jià)重要供應(yīng)品和服務(wù)的供應(yīng)商 Records of evaluation shall be maintained保存這些評(píng)價(jià)的記錄 AVL (Approved Vendors List) shall be maintained獲批準(zhǔn)的供應(yīng)商名單 Copy Right Reserve

42、d by UL-CCIC Company LimitedIEC4 ,Rev.01Page 364.7 Service to the Client服務(wù)顧客Afford clients cooperation to與客戶或其代表合作 Clarify clients request明確客戶的要求 Monitor laboratorys performance監(jiān)視其工作有關(guān)的操作 Ensure confidentiality to other clients保密Cooperation may include:合作可包括 Reasonable access to relevant areas for w

43、itness見證 Preparation, packaging, and dispatch of test and/or calibration items制備包裝分發(fā)樣品 Communication process溝通 Client surveys (positive and negative feedback from clients)客戶調(diào)查 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 374.7 Service to the Client服務(wù)顧客 應(yīng)理解并明確客戶要求應(yīng)理解并明確客戶要求 合理準(zhǔn)許客戶合理

44、準(zhǔn)許客戶 到現(xiàn)場(chǎng)監(jiān)督到現(xiàn)場(chǎng)監(jiān)督開展定期的客戶調(diào)查開展定期的客戶調(diào)查是簡(jiǎn)便有效的方法是簡(jiǎn)便有效的方法. OFFER A SMILE. Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 384.8 Complaints報(bào)怨Policy and procedure for compliant resolution有政策和程序處理來(lái)自客戶的抱怨Records shall be maintained:保持記錄 Complaints抱怨 Investigations調(diào)查 Corrective actions taken糾正措施 C

45、opy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 394.9 Control of Nonconforming Testing and/or Calibration Work(I)不符合檢測(cè)和校準(zhǔn)工作的控制IPolicy and procedures for deviations shall ensure that有政策和程序確保: Responsibilities and authorities for the management of nonconforming work are designated確定對(duì)不符合工

46、作進(jìn)行管理的責(zé)任和權(quán)力, 確定所采取的措施 Evaluation of the significance of the nonconforming work is made評(píng)價(jià)不符合工作的嚴(yán)重性 Remedial actions (containment) are taken immediately立即采取糾正措施 Client is notified and work is recalled where necessary必要時(shí),通知客戶并取消工作 Responsibility for authorizing the resumption of work is defined確定批準(zhǔn)恢復(fù)工作

47、的職責(zé) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 404.9 Control of Nonconforming Testing and/or Calibration Work(II)不符合檢測(cè)和校準(zhǔn)工作的控制IIExamples: 例如 Customer complaints, Internal/External audits, Management review顧客投訴 內(nèi)/外審 管理評(píng)審 Test/Calibration/Maintenance results and Quality Control (e.

48、g. IQC)測(cè)試/校準(zhǔn)/維護(hù)結(jié)果和質(zhì)量控制 Staff observations or supervision/Documentation checks人員監(jiān)督管理/文件檢查Corrective action procedures given in 4.11 shall be promptly followed where the nonconforming work could recur不合格工作重復(fù)發(fā)生應(yīng)立即運(yùn)行4.11規(guī)定的糾正措施 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 414.10 4.10 I

49、mprovement Improvement 改進(jìn)改進(jìn)The laboratory shall continually improve the effectiveness of its management system through the use of: quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management review 實(shí)驗(yàn)室應(yīng)運(yùn)用品質(zhì)政策、品質(zhì)目標(biāo)、稽核結(jié)果、據(jù)分析、矯正及預(yù)防措施及管審查， 持續(xù)改進(jìn)其管系統(tǒng)的有效性。

50、Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 424.11 Corrective Action(I)糾正措施糾正措施IEstablish policy and procedure and designate appropriate authorities for implementing corrective action制定實(shí)施糾正措施的政策和程序Determine the root causes of the problem確定問(wèn)題的根本原因Selection and implementation of cor

51、rective actions糾正措施的選擇和執(zhí)行 Identify potential corrective actions識(shí)別潛在的糾正措施 Appropriate to the magnitude and the risk of the problem力度應(yīng)與問(wèn)題的嚴(yán)重性和危險(xiǎn)性相適應(yīng) Document and implement any changes resulting from corrective actions文件化并執(zhí)行任何需要的變更 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 434.11 C

52、orrective Action糾正措施糾正措施IIMonitor the results to ensure that the corrective actions taken have been effective監(jiān)控結(jié)果確保措施有效Additional audits shall be done ASAP at appropriate areas in accordance with 4.13 where nonconformances not comply with laboratorys policies and procedures, or ISO 17025如果發(fā)現(xiàn)導(dǎo)致與實(shí)驗(yàn)室方針

53、和程序不符合,應(yīng)盡快實(shí)施附加審核 Note：?jiǎn)栴}嚴(yán)重或?qū)I(yè)務(wù)有風(fēng)險(xiǎn)時(shí)采用，否則不強(qiáng)制要求進(jìn)行。 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 444.12 Preventive Action預(yù)防措施預(yù)防措施Develop, implement and monitor action plans when preventive action is required需要時(shí)制定監(jiān)控措施計(jì)劃 To prevent from recurrence防止再發(fā)生 To take advantage of the opportunit

54、ies for improvement有利于持續(xù)改進(jìn)Pro-active vs. Reactive (preventive vs. corrective action)事先對(duì)事后Procedure to ensure that the preventive actions are effective確保預(yù)防措施有效Preventive action might involve analysis of data, including trend and risk analysis and proficiency-testing results涉及數(shù)據(jù)分析,包括趨勢(shì)（SPC）和風(fēng)險(xiǎn)水平和水平測(cè)試結(jié)

55、果的分析 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 45糾正糾正 ( (Corrective) V.S. Corrective) V.S. 預(yù)防預(yù)防 ( (Preventive)Preventive) 糾正糾正 解決已存在的問(wèn)題 被動(dòng)的 (Reactive) 避免問(wèn)題再發(fā)生 通常為單一事件 通常屬于局部性的 通常需要糾正對(duì)策 消除問(wèn)題的真因(治本) 預(yù)防 解決潛在的問(wèn)題 主動(dòng)的 (Proactive) 讓問(wèn)題不會(huì)發(fā)生 資料分析/趨勢(shì)分析 通常為全面性的 僅趨勢(shì)不好時(shí)才需要采取對(duì)策 消除潛在問(wèn)題的真因 Copy

56、Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 46趨勢(shì)圖與預(yù)防措施月份 1 2 3 4 5 6 7 8 9 10 11 12 每月客訴件數(shù)510目標(biāo)值：客訴件數(shù)每月小于10件采取預(yù)防措施采取預(yù)防措施趨勢(shì)變差趨勢(shì)變好預(yù)防措施有效 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 47糾正與預(yù)防措施的步驟 (8D)D1 :成立問(wèn)題處理小組D2 : 問(wèn)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

57、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) Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 484.13 Control of Records(I)記錄的控制IProcedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records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

58、術(shù)記錄的程序Quality records include internal audit & management review reports and records of corrective & preventive actions質(zhì)量記錄包括內(nèi)審管理評(píng)審和糾正措施All records shall be legible, stored, retained and readily retrievable in a suitable environment所有記錄應(yīng)清晰明了，便于存放和保存Retention times shall be established規(guī)定保存時(shí)間A

59、ll records shall be held secure and in confidence所有記錄應(yīng)保證安全保密Documented procedures to protect and back-up records stored electronically and to prevent unauthorized access有程序來(lái)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 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 494.13 Control of Records(II)記錄控制記錄控制I

60、IRetain records of original observations and derived data for a defined period對(duì)原始數(shù)據(jù)導(dǎo)出數(shù)據(jù)保持一定時(shí)間 Sufficient for repetition充分可接受 Identity of responsible personnel標(biāo)識(shí)責(zé)任人Observations, data and calculations shall be recorded觀察值,數(shù)據(jù)和計(jì)算值應(yīng)記錄Mistakes in records shall be crossed out, not erased, and the correct value entered along