ISO17025_培訓(xùn)教材

1、 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 1 檢測和校準實驗室能力的通用要求檢測和校準實驗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 過程方法實驗室審核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 請列舉你認為一個請列舉你認為一個好的校好的校準準或或檢測實驗檢測實驗室室應(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。(使用時間使用時間：10分分鐘鐘)請請各各組討論后組討論后，派一名代表上臺，派一名代表上臺發(fā)發(fā)表。表。 (各各組組使用使用時間時間: : 3 分分鐘鐘以內(nèi)以內(nèi))ISO/IEC 17025 標(biāo)準介紹標(biāo)準介紹 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、理體系運行、具有技術(shù)能力并能提供正確證明其按管理體系運行、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驗室，也必須可用作認可準則主要適用實驗室，也必須可用作認可準則必須代替必須代替EN45001EN45001，達成國際上的統(tǒng)一達成國際上的統(tǒng)一必須明確與必須明確與ISO9000ISO9000的關(guān)系的關(guān)系作為國際標(biāo)準出版作為國際標(biāo)準出版擴大范圍，納入抽樣、新方法制定和專業(yè)判斷內(nèi)容擴大范圍，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、避免制定過多應(yīng)用或解釋性文件避免制定過多應(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調(diào)了管理強調(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)容擴大了合同評審內(nèi)容擴大了合同評審內(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) 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)改進章節(jié)（新增加了持續(xù)改進章節(jié)（20052005版本）版本） 增加了管理評審過程中應(yīng)包括的內(nèi)容增加了管理評審過程中應(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）的準則增加了新方法制定要求，規(guī)定了有效性（確認）的準則 強化了對測量不確定度要求強化了對測量不確定度要求 區(qū)分開校準和檢測實驗室的量值溯源性區(qū)分開校準和檢測實驗室的量值溯源性 結(jié)果報告增加了很多內(nèi)容結(jié)果報告增加了很多內(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 (機械機械性性)Acoustical & Vibration (聲學(xué)與振動聲學(xué)與振動)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中與實驗室管理中與實驗室管理體系所覆蓋的檢測和校準服務(wù)有關(guān)的所有要求體系所覆蓋的檢測和校準服務(wù)有關(guān)的所有要求實驗室質(zhì)量管理體系符合實驗室質(zhì)量管理體系符合ISO 9001的要求，并不證明的要求，并不證明實驗室具有出具技術(shù)上有效數(shù)據(jù)和結(jié)果的能力實驗室具有出具技術(shù)上有效數(shù)據(jù)和結(jié)果的能力實驗室質(zhì)量管理體系符合本準則，也不意味其運作符實驗室質(zhì)量管理體系符合本準則，也不意味其運作符合合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)行測試與校正的一般能力要求， 包括取樣涵蓋了使用標(biāo)準標(biāo)準、非非標(biāo)準實驗標(biāo)準實驗室自行室自行開發(fā)開發(fā)之方法

11、 所執(zhí)行的測試與校正適用于所有的實驗實驗室，而與實驗實驗室的人數(shù)和所執(zhí)行的測試與校正的范圍無關(guān)本準則中的注是對正文的說明、舉例和指導(dǎo)。它們既不包含要求，也不構(gòu)成本準則的主體部分本準則是CNAS對檢測和校準實驗室能力進行認可的依據(jù)，也可用于實驗室建立管理體系，以及為實驗室的客戶、法定管理機構(gòu)對實驗室的能力進行確認或承認提供指南不涵蓋實驗實驗室作業(yè)的相關(guān)法規(guī)與安全要求ISO/IEC 17025 標(biāo)準介紹標(biāo)準介紹 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） 任何國家的認可活動，都是以符合該國的安全與健康相關(guān)法律任何國家的認可活動，都是以符合該國的安全與健康相關(guān)法律/ /法規(guī)為前提的法規(guī)為前提的 實驗室的活動，也應(yīng)以遵守實驗室的活動，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合同評審合同評審4.5 Subcontracting of Tests and Calibrations檢測和校準的分包檢測和校準的分包4.6 Purchasing Services and Supplies服服務(wù)和供應(yīng)品的采購務(wù)和供應(yīng)品的采購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不合格檢測和校準的控制不合格檢測和校準的

15、控制4.10 Improvement 改進改進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紀錄控制紀錄控制4.14 Internal Audits內(nèi)審內(nèi)審4.15 Management Reviews管理評審管理評審 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 194.1 Organization (I)組織組織ILegally responsible法律實體Meet Standard, Cu

16、stomer, Regulatory & Accreditation Bodies Requirements滿足標(biāo)準 客戶 法規(guī) 和認可機構(gòu)的要求Cover work carried out in permanent, offsite,mobile or temporary facilities覆蓋固定 外部 移動或臨時場所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三方實驗室的獨立性 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 204.1 Organization (II)組織組織IIThe laboratory shall實驗室應(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方針和程序確保機密信息和所有權(quán)的保護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 誠實性 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對測試和校準人員實施適當(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、實施和維持與其活動范圍相適應(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實驗室服務(wù)標(biāo)準的聲明 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) 實驗實驗室室質(zhì)量方針質(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) 實驗實驗室室質(zhì)量質(zhì)量目目標(biāo)標(biāo) 每月客訴件數(shù)不超過2件 延誤報告交期不超過 1天 報告出

25、錯率小于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) 可達成性可達成性v.s. 有挑戰(zhàn)性有挑戰(zhàn)性 (Attainable) 相關(guān)性相關(guān)性 (Relevant) 時限性時限性 (Timeframe)上司的支持與承諾，以及員工的認同是達上司的支持與承諾，以及員工的認同是達成目標(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實驗室的工作范圍實驗室的工作范圍 專業(yè)領(lǐng)域和學(xué)科專業(yè)領(lǐng)域和學(xué)科 校準領(lǐng)域校準領(lǐng)域 檢測領(lǐng)域檢測領(lǐng)域 實驗室的質(zhì)量體系應(yīng)覆蓋其工作范圍實驗室的質(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 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 測試校準方法 圖紙 軟件 規(guī)范和指導(dǎo)書等q

29、Document Approval and Issue文件的批準和發(fā)布 All documents shall be reviewed and approved prior to issue發(fā)布前的審查和批準 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文件的價值文件可以溝通意圖、統(tǒng)一行動，有助于：文件可以溝通意圖、統(tǒng)一行動，有助于： 實現(xiàn)產(chǎn)品質(zhì)量和質(zhì)量改進

31、；實現(xiàn)產(chǎn)品質(zhì)量和質(zhì)量改進； 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)； 評價體系的有效性。評價體系的有效性。 文件的制定應(yīng)是一項文件的制定應(yīng)是一項增值增值的活動的活動 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)書和合同的評審Iv Procedures for contract review shall ensure that:建立和維持評審客戶要求，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測和校準方法 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)書和合同的評審IIv Records of review, including

36、significant changes and discussions with client, shall be maintained保持評審記錄包括重大變化的記錄v Client shall be informed of any deviation from the contract對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檢測和校準的分包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v Laboratory is responsible to the client for the subcontractors work, except client or regulatory authority specifies實驗室就其分包方的工作對客戶負責(zé)v Maintain a register of all subcontra

39、ctors保存所有分包方的注冊資料 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Iq Policy and procedures for擁有的政策和程序 Selection of services and supplies選擇和購買的服務(wù)和供應(yīng)品 Purchase, reception and storage of reagent and consumable materials采購接受儲存試劑和易耗品q Purchas

40、ing documents shall be reviewed and approved for technical content prior to release采購文件在發(fā)出之前,其技術(shù)內(nèi)容應(yīng)經(jīng)過審查和批準q Inspection or verification of purchased services or materials: 檢查驗證購買的服務(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IIq Evaluation of suppliers for critical consumables and services:評價重要供應(yīng)品和服務(wù)的供應(yīng)商 Records of evaluation shall be maintained保存這些評價的記錄 AVL (Approved Vendors List) shall be maintained獲批準的供應(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 合理準許客戶合理

44、準許客戶 到現(xiàn)場監(jiān)督到現(xiàn)場監(jiān)督開展定期的客戶調(diào)查開展定期的客戶調(diào)查是簡便有效的方法是簡便有效的方法. OFFER A SMILE. Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 384.8 Complaints報怨Policy and procedure for compliant resolution有政策和程序處理來自客戶的抱怨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)不符合檢測和校準工作的控制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確定對不符合工

46、作進行管理的責(zé)任和權(quán)力, 確定所采取的措施 Evaluation of the significance of the nonconforming work is made評價不符合工作的嚴重性 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,通知客戶并取消工作 Responsibility for authorizing the resumption of work is defined確定批準恢復(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)不符合檢測和校準工作的控制IIExamples: 例如 Customer complaints, Internal/External audits, Management review顧客投訴 內(nèi)/外審 管理評審 Test/Calibration/Maintenance results and Quality Control (e.

48、g. IQC)測試/校準/維護結(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 改進改進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 實驗室應(yīng)運用品質(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制定實施糾正措施的政策和程序Determine the root causes of the problem確定問題的根本原因Selection and implementation of cor

51、rective actions糾正措施的選擇和執(zhí)行 Identify potential corrective actions識別潛在的糾正措施 Appropriate to the magnitude and the risk of the problem力度應(yīng)與問題的嚴重性和危險性相適應(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)致與實驗室方針

53、和程序不符合,應(yīng)盡快實施附加審核 Note：問題嚴重或?qū)I(yè)務(wù)有風(fēng)險時采用，否則不強制要求進行。 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需要時制定監(jiān)控措施計劃 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Pro-active vs. Reactive (preventive vs. corrective action)事先對事后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（SPC）和風(fēng)險水平和水平測試結(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 解決已存在的問題 被動的 (Reactive) 避免問題再發(fā)生 通常為單一事件 通常屬于局部性的 通常需要糾正對策 消除問題的真因(治本) 預(yù)防 解決潛在的問題 主動的 (Proactive) 讓問題不會發(fā)生 資料分析/趨勢分析 通常為全面性的 僅趨勢不好時才需要采取對策 消除潛在問題的真因 Copy

56、Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Page 46趨勢圖與預(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)防措施趨勢變差趨勢變好預(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 :成立問題處理小組D2 : 問題描述D3 : 采取臨時的圍堵措施D4 : 真因分析D5 : 采取永久的糾正措施D6 : 執(zhí)行并確認糾正措

57、施D7 : 防止再發(fā)生 (預(yù)防措施)D8 : 肯定團隊和個人表現(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)建立并維持識別、收集、索引、存取、存檔、存放、維護和清理質(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有程序來保護和備份以電子形式存儲的記錄，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對原始數(shù)據(jù)導(dǎo)出數(shù)據(jù)保持一定時間 Sufficient for repetition充分可接受 Identity of responsible personnel標(biāo)識責(zé)任人Observations, data and calculations shall be recorded觀察值,數(shù)據(jù)和計算值應(yīng)記錄Mistakes in records shall be crossed out, not erased, and the correct value entered along