ISO9001AwarenessTrainingforstaffs(PPT 114页).ppt

ISO9000:2000AwarenessTrainingISO9000:2000認識培訓QualityManagementSystemStandard質量管理系統標準,ISO-国际标准化组织,ISO-InternationalOrganizationforStandardization成立于1947年2月23日总部设于瑞士日内瓦推动和协调国际标准化工作推动国际贸易的发展120多个成员国组成，包括欧共体和欧盟的所有成员国，美国、日本、中国、新加坡等,国际标准制定的过程,TC技术委员会TC176：质量管理和质量保证技术委员会成立于1980年制定质量管理和质量保证标准ISO9000族标准就是由ISO/TC176制定的所有国际标准,ChangesfromISO9000:1994ISO9000:1994更改概要,ISO9001,ISO9002,ISO9003,ISO9001:2000-,QMSrequirements質量管理系統要求,ISO9000:2000-,Fundamentalsandbesafeguardedfromadjustmentsthatwouldinvalidatethemeasurementresult妥善防護以免因調整不當而使其校正失效Protectedfromdamageanddeteriorationduringhandling,maintenanceandstorage在搬運、維護、和儲存時應加以保護以避色損傷和變質,7.6Controlofmonitoringandmeasuringdevices測量和監控裝置控制,Assessandrecordthevalidityofthepreviousmeasuringresultswhentheequipmentisfoundnottoconformtorequirements(see4.2.4).當發現校正失效時，應評估之前的結果並採取適當的措施Theabilityofanycomputersoftwareusedinthemonitoringandmeasurementofspecifiedrequirementsshallbeconfirmedpriortoinitialusetosatisfytheintendedapplication.Thisshallbeundertakenandreconfirmedasnecessary.為特定要求而使用在量測和監督的軟體在使用前應予以確認.NOTESeeISO10012-1andISO10012-2forguidance.備註:參閱ISO10012指引,8Measurement,analysisandimprovement測量、分析和改進,8.1General總則8.2Monitoringandmeasurement測量和監控8.3Controlofnonconformingproduct不合格控制8.4Analysisofdata資料分析8.5Improvement改進,8.1General總則,Define,planandimplementmeasurementandmonitoringprocesses確定、計劃和實施測量及監控過程Demonstrateconformityoftheproduct保證產品的符合性EnsuretheconformityoftheQMS保證質量管理系統的符合性ContinuallyimprovetheeffectivenessoftheQMS持續改進質量管理系統的有效性Determineanduseapplicablemethods,includestatisticaltechniques,andtheextentoftheiruse鑒別和使用合適方法，包括統計工具，及其使用的內容,8.2Monitoringandmeasurement測量及監控,8.2.1Customersatisfaction顧客滿8.2.2Internalaudit內部審核8.2.3Monitoringandmeasurementofprocesses測量及監控過程8.2.4Monitoringandmeasurementofproduct測量及監控產品,8.2Monitoringandmeasurement測量及監控,MeasurementoftheperformanceoftheQMS質量管理系統表現的一個測量Monitorcustomerperceptionwhethertheorganizationhasfulfilledcustomerrequirements監控顧客對於組織已否滿足客戶要求的看法Determinemethodsforobtainingandusingthisinformation規定收集及應用資訊的方法,8.2Monitoringandmeasurement測量及監控,Conductinternalauditsatplannedintervalstodeterminewhetherthequalitymanagementsystem組織應執行定期性的內部審核，以判斷質量管理系統：Conformstotheplannedarrangements(see7.1),totherequirementsofthisInternationalStandardandtothequalitymanagementsystemrequirements符合本國際標準的要求Effectivelyimplementedandmaintained已有效地運作和維持,8.2Monitoringandmeasurement測量及監控,Anauditprogramshallbeplanned,takingintoconsiderationthestatusandimportanceoftheprocessesandareastobeaudited,aswellastheresultsofpreviousaudits組織應制定審核計劃，該計劃將依活動的狀況和重要性、被審核的範圍和以往審核結果列作考慮Theauditcriteria,scope,frequencyandmethodsshallbedefined審核範圍、頻率和方法應作界定Auditorsshallnotaudittheirownwork審核應由與受審方之工作無直接關係的人員執行Theresponsibilitiesandrequirementsforplanningandconductingaudits,andforreportingresultsshallbedefined審核的策劃、執行及報告等責任及要求應作界定,8.2Monitoringandmeasurement測量及監控,Follow-upactivitiesshallincludetheverificationoftheactionstakenandthereportingofverificationresults(see8.5.2)後續跟催活動應包括驗證糾正措施並記錄驗證結果Themanagementresponsiblefortheareabeingauditedshallensurethatactionsaretakenwithoutunduedelaytoeliminatedetectednonconformitiesandtheircauses管理階層應確定對審核期間所發現之缺失所採取的糾正措施在在限期前執行NOTESeeISO10011-1,ISO10011-2andISO10011-3forguidance.備註:參閱ISO10011-1,ISO10011-2和ISO10011-3指引,8.2Monitoringandmeasurement測量及監控,8.2.3Monitoringandmeasurementofprocesses測量及監控過程Applysuitablemethodsformonitoringandmeasurement組織應採用適當量測和監督方法Demonstratetheabilityoftheprocessestoachieveplannedresults方法需展示過程可達致計劃結果的能力Correctionandcorrectiveactionshallbetakenifnotachieveinordertoensureconformityoftheproduct若不能達致，需採取糾正和糾正措施以確保產品的符合性,8.2Monitoringandmeasurement測量及監控,8.2.4Monitoringandmeasurementofproduct測量及監控產品Monitorandmeasurethecharacteristicsoftheproducttoverifythatproductrequirementsaresatisfied組織應量測和監督產品的特性，以驗證產品符合要求Carryoutatappropriatestagesoftheproductrealizationprocessinaccordancewiththeplannedarrangements(see7.1)這些監督和量測應架構在產品實現流程的適當階段Evidenceofconformitywiththeacceptancecriteriashallbemaintained.符合允收標準的證據應予以文件化Recordsshallindicatetheperson(s)authorizingreleaseofproduct(see4.2.4).記錄應能顯示負責產品放行的權責人員,8.2Monitoringandmeasurement測量及監控,Productreleaseandservicedeliveryshallnotproceeduntiltheplannedarrangements(see7.1)havebeensatisfactorilycompleted.Otherwiseitshouldbeapprovedbyarelevantauthorityorthecustomer.只有在所有規定的活動都已圓滿完成後，產品才能放行和服務才能交付，不然應取得客戶的核准.Noclearregulationonreceive,processandfinalinspectionofproduct沒有明確規定進貨，過程和最終檢驗,8.3Controlofnonconformingproduct不合格控制,Ensureproductwhichdoesnotconformtoproductrequirementsisidentifiedandcontrolledtopreventitsunintendeduseordelivery組織應確保不合格的產品予以鑑別和管制，以防止無意的使用或交貨Thecontrolsandrelatedresponsibilitiesandauthoritiesforshallbedefinedinadocumentedprocedure這些活動應於書面程序內界定,8.3Controlofnonconformingproduct不合格控制,Theorganizationshall:組織應：bytakingactiontoeliminatethedetectednonconformity不合格產品應改正並於改正後重新查驗以顯示其符合性byauthorizingitsuse,releaseoracceptanceunderconcessionbyarelevantauthorityand,whereapplicable,bythecustomer當有所要求時，不合格產品的使用應向客戶、實際使用者、驗證團體或其它團體報告取得特准bytakingactiontoprecludeitsoriginalintendeduseorapplication採取措施防止最初的用途或應用,8.3Controlofnonconformingproduct不合格控制,Recordsofthenatureofnonconformitiesandanysubsequentactionstaken,includingconcessionsobtained,shallbemaintained(see4.2.4)保存不合格產品的性質及相應措施的記錄Takeappropriateactionstotheeffectsorpotentialofthenonconformity在交付後或開始使用後方查出，需針對影響或潛在影響採取適當措施Whennonconformingproductiscorrecteditshallbesubjecttoreverificationtodemonstrateconformitytotherequirements改正後的產品需要再驗證以顯示已符合要求,8.3Controlofnonconformingproduct不合格控制,Ifnonconformingproductisdetectedafterdeliveryorusehasstarted,theorganizationshalltakeactionappropriatetotheeffects,orpotentialeffects,ofthenonconformity當不合格產品是在交貨後或開始使用後才被發覺，組織應視不符合狀況採取適當的措施,8.4Analysisofdata數字分析,DeterminethesuitabilityandeffectivenessoftheQMSsystem確定質量管理系統的適用性和有效性Identifyimprovement識別改進Informationinclude資料包括：Customersatisfaction顧客滿意/不滿意Conformancetoproductrequirements與顧客要求符合性Characteristicsandtrendsofprocessesandproducts過程及產品特性和趨勢Suppliers供方Source:Monitoringandmeasurementactivitiesorotherrelatedsource來源：測量和監控活動及其他相關來源,8.5Improvement改進,8.5.1Continualimprovement策劃持續改進ContinuallyimprovetheeffectivenessoftheQMSthroughtheuseof需持續改進質量管理系統的有效性Qualitypolicy質量方針Qualityobjectives質量目標Results審核結果Analysisofdata資料分析Correctiveandpreventiveactions糾正和預防措施Managementreview管理評審,8.5Improvement改進,8.5.2Correctiveaction糾正措施Correctiveactionsshallbetokenactiontoeliminatethecauseofnonconformitiesinordertopreventrecurrence組織應採取糾正措施以清除不合格的原因並防止再次發生Correctiveactionsshallbeappropriatetotheeffectsofthenonconformitiesencountered糾正措施應與所遭遇問題的衝擊相符,8.5Improvement改進,Adocumentedprocedureshallbeestablishedtodefinerequirementsfor糾正措施程序應包括：Reviewingnonconformities(includingcustomercomplaints)不符合格的鑑別（包括客戶投訴）Determiningthecausesofnonconformities確定不符合的原因Evaluatingtheneedforactiontoensurethatnonconformitiesdonotrecur評估為確保不符合不再發生所需的措施Determiningandimplementingactionneeded確定和實施所需的糾正措施Recordsoftheresultsofactiontaken(see4.2.4)記錄措施實施的結果reviewingcorrectiveactiontaken審查所採取的糾正措施,8.5Improvement改進,8.5.3Preventiveaction預防措施Determinepreventiveactiontoeliminatethecausesofpotentialnonconformitiesinordertopreventtheiroccurrence組織應確定預防預防措施以消除潛在不符合的原因以避免其發生Preventiveactionsshallbeappropriatetotheeffectsofthepotentialproblems.預防措施與所遭遇問題的大小和衝擊相符,8.5Improvement改進,Adocumentedprocedureshallbeestablishedtodefinerequirementsfor預防措施程序應包括:Determiningpotentialnonconformitiesandtheircauses鑑別潛在的不符合Evaluatingtheneedforactiontopreven