iso9001中英文对照(doc 13)

QUALITYMANAGEMENTSYSTEMSREQUIREMENTS1SCOPE11GENERALTHISINTERNATIONALSTANDARDSPECIFIESREQUIREMENTSFORAQUALITYMANAGEMENTSYSTEMWHEREANORGANIZATIONANEEDSTODEMONSTRATEITSABILITYTOCONSISTENTLYPROVIDEPRODUCTTHATMEETSCUSTOMERANDAPPLICABLEREGULATORYREQUIREMENTS,ANDBAIMSTOACHIEVECUSTOMERSATISFACTIONTHROUGHTHEEFFECTIVEAPPLICATIONOFTHESYSTEM,INCLUDINGPROCESSESFORCONTINUALIMPROVEMENTOFTHESYSTEMANDTHEASSURANCEOFCONFORMITYTOCUSTOMERANDAPPLICABLEREGULATORYREQUIREMENTSNOTEINTHISINTERNATIONALSTANDARD,THETERM“PRODUCT”APPLIESTOTHEPRODUCTINTENDEDFOR,ORREQUIREDBY,ACUSTOMER12APPLICATIONALLREQUIREMENTSOFTHISINTERNATIONALSTANDARDAREGENERICANDAREINTENDEDTOBEAPPLICABLETOALLORGANIZATIONS,REGARDLESSOFTYPE,SIZEANDPRODUCTPROVIDEDWHEREANYREQUIREMENTSOFTHISINTERNATIONALSTANDARDCANNOTBEAPPLIEDDUETOTHENATUREOFANORGANIZATIONANDITSPRODUCT,THISCANBECONSIDEREDFOREXCLUSIONWHEREEXCLUSIONSAREMADE,CLAIMSOFCONFORMITYTOTHISINTERNATIONALSTANDARDARENOTACCEPTABLEUNLESSTHESEEXCLUSIONSARELIMITEDTOREQUIREMENTSWITHINCLAUSE7,ANDSUCHEXCLUSIONSDONOTAFFECTTHEORGANIZATIONSABILITY,ORRESPONSIBILITY,TOPROVIDEPRODUCTTHATMEETSCUSTOMERANDAPPLICABLEREGULATORYREQUIREMENTS2NORMATIVEREFERENCETHEFOLLOWINGNORMATIVEDOCUMENTCONTAINSPROVISIONSWHICH,THROUGHREFERENCEINTHISTEXT,CONSTITUTEPROVISIONSOFTHISINTERNATIONALSTANDARDFORDATEDREFERENCES,SUBSEQUENTAMENDMENTSTO,ORREVISIONSOF,ANYOFTHESEPUBLICATIONSDONOTAPPLYHOWEVER,PARTIESTOAGREEMENTSBASEDONTHISINTERNATIONALSTANDARDAREENCOURAGEDTOINVESTIGATETHEPOSSIBILITYOFAPPLYINGTHEMOSTRECENTEDITIONOFTHENORMATIVEDOCUMENTINDICATEDBELOWFORUNDATEDREFERENCES,THELATESTEDITIONOFTHENORMATIVEDOCUMENTINDICATEDBELOWFORUNDATEDREFERENCES,THELATESTEDITIONOFTHENORMATIVEDOCUMENTREFERREDTOAPPLIESMEMBERSOFISOANDIECMAINTAINREGISTERSOFCURRENTLYVALIDINTERNATIONALSTANDARDSISO90002000,QUALITYMANAGEMENTSYSTEMSFUNDAMENTALSANDVOCABULARY3TERMSANDDEFINITIONSFORTHEPURPOSESOFTHISINTERNATIONALSTANDARD,THETERMSANDDEFINITIONSGIVENINISO9000APPLYTHEFOLLOWINGTERMSUSEDINTHISEDITIONOFISO9001TODESCRIBETHESUPPLYCHAIN,HAVEBEENCHANGEDTOREFLECTTHEVOCABULARYCURRENTLYUSEDSUPPLIERORGANIZATIONCUSTOMERTHETERM“ORGANIZATION”REPLACESTHETERM“SUPPLIER”USEDINISO9001”1994,ANDREFERSTOTHEUNIT,TOWHICHTHISINTERNATIONALSTANDARDAPPLIESALSO,THETERM“SUPPLIER”NOWREPLACESTHETERM“SUBCONTRACTOR”THROUGHOUTTHETEXTOFTHISINTERNATIONALSTANDARD,WHEREVERTHETERM”PRODUCT”OCCURS,ITCANALSOMEAN“SERVICE”品質管理体系要求1範圍11通則本國際標準規定了品質管理体系的各項要求，以滿足當組織有下列需求時A須要展現其能力足以穩定地提供符合客戶或適當法規要求之產品,和B透過体系的有效運用，包括持續改善與保證達成客戶和法規要求的流程，達到客戶滿意備註本國際標準中，產品一詞適用於預期提供予顧客或其所需要之產品。12應用此國際標準的所有要求乃通用性要求且期望能適用於所有組織,無論其行業、規模及所提供的產品，本國際標準的任何要求若因組織或產品之特性而無法適用時可考慮予以排除當本國際標準的任何要求被排除時，則組織不得宣稱其符合本國際標準，除非所排除的要求局限於本國際標準的第七章，且不影響組織提供符合客戶及適當法規要求產品的能力或責任2引用標準本國際標準引用下列標準的內容以構成本國際標準的條款，所引用的標準如具日期版次，則其后之修訂或改版均不適用於本國際標準然而依據本國際標準達成共識之各團體仍應探求使用下列標準文件最新版次的可能。引用的標準如未指定日期版次，則應使用最新的引用標準ISO及IEC會員皆維持有最新有效國際標準的登錄清單。ISO90002000品質管理体系原理與詞彙3名詞與定義ISO90002000中之與定義均適用於本國際標準。本國際標準用來描述供應鏈之名詞更動如下，以反映目前的習慣用語供應商組織顧客本版次以“組織”取代先前1994版次使用的”供應商”，以表示採用本國際標準的單位。而”供應商”則用來取代之前版次的”分包商”。本國際標準全文之中,”產品”一詞亦等同於”服務”。4QUALITYMANAGEMENTSYSTEM41GENERALREQUIREMENTSTHEORGANIZATIONSHALLESTABLISH,DOCUMENT,IMPLEMENTANDMAINTAINAQUALITYMANAGEMENTSYSTEMANDCONTINUALLYIMPROVEITSEFFECTIVENESSINACCORDANCEWITHTHEREQUIREMENTSOFTHISINTERNATIONALSTANDARDTHEORGANIZATIONSHALLAIDENTIFYTHEPROCESSESNEEDEDFORTHEQUALITYMANAGEMENTSYSTEM,ANDTHEIRAPPLICATIONTHROUGHOUTTHEORGANIZATIONSEE12BDETERMINETHESEQUENCEANDINTERACTIONOFTHESEPROCESSESCDETERMINECRITERIAANDMETHODSNEEDEDTOENSURETHATBOTHTHEOPERATIONANDCONTROLOFTHESEPROCESSESAREEFFECTIVEDENSURETHEAVAILABILITYOFRESOURCESANDINFORMATIONNECESSARYTOSUPPORTTHEOPERATIONANDMONITORINGOFTHESEPROCESSESEMONITOR,MEASUREANDANALYSISTHESEPROCESSES,ANDFIMPLEMENTACTIONNECESSARYTOACHIEVEPLANNEDRESULTSANDCONTINUALIMPROVEMENTOFTHESEPROCESSESTHESEPROCESSESSHALLBEMANAGEDBYTHEORGANIZATIONINACCORDANCEWITHTHEREQUIREMENTSOFTHISINTERNATIONALSTANDARDWHEREANORGANIZATIONCHOOSESTOOUTSOURCEANYPROCESSTHATAFFECTSPRODUCTCONFORMITYWITHREQUIREMENTS,THEORGANIZATIONSHALLENSURECONTROLOVERSUCHPROCESSESCONTROLOFSUCHOUTSOURCEDPROCESSESSHALLBEIDENTIFIEDWITHINTHEQUALITYMANAGEMENTSYSTEMNOTEPROCESSESNEEDEDFORTHEQUALITYMANAGEMENTSYSTEMREFERREDTOABOVESHOULDINCLUDEPROCESSESFORMANAGEMENTACTIVITIES,PROVISIONOFRESOURCES,PRODUCTREALIZATIONANDMEASUREMENT42DOCUMENTATIONREQUIREMENTS421GENERALTHEQUALITYMANAGEMENTSYSTEMDOCUMENTATIONSHALLINCLUDEADOCUMENTEDSTATEMENTSOFAQUALITYPOLICYANDQUALITYOBJECTIVESBAQUALITYMANUALCDOCUMENTEDPROCEDURESREQUIREDBYTHISINTERNATIONALSTANDARDDDOCUMENTSNEEDEDBYTHEORGANIZATIONTOENSURETHEEFFECTIVEPLANNINGOPERATIONANDCONTROLOFITSPROCESSES,ANDERECORDSREQUIREDBYTHISINTERNATIONALSTANDARDSEE424NOTE1WHERETHETERM“DOCUMENTEDPROCEDURE”APPEARSWITHINTHISINTERNATIONALSTANDARD,THISMEANSTHATTHEPROCEDUREISESTABLISHED,DOCUMENTED,IMPLEMENTEDANDMAINTAINEDNOTE2THEEXTENTOFTHEQUALITYMANAGEMENTSYSTEMDOCUMENTATIONCANDIFFERFROMONEORGANIZATIONTOANOTHERDUETOATHESIZEOFORGANIZATIONANDTYPEOFACTIVITIESBTHECOMPLEXITYOFPROCESSESANDTHEIRINTERACTIONSANDCTHECOMPETENCEOFPERSONNELNOTE3THEDOCUMENTATIONCANBEINANYFORMORTYPEOFMEDIUM422QUALITYMANUALTHEORGANIZATIONSHALLESTABLISHANDMAINTAINAQUALITYMANUALTHATINCLUDESATHESCOPEOFTHEQUALITYMANAGEMENTSYSTEM,INCLUDINGDETAILSOFANDJUSTIFICATIONFORANYEXCLUSIONSSEE12BTHEDOCUMENTEDPROCEDURESESTABLISHEDFORTHEQUALITYMANAGEMENTSYSTEM,ORREFERENCETOTHEM,ANDCADESCRIPTIONOFTHEINTERACTIONBETWEENTHEPROCESSESOFTHEQUALITYMANAGEMENTSYSTEM4品質管理体系41一般要求組織應遵照本際際標準的要求建立、文件化、執行、維持品質管理体系並持續改善其有效性。組織應A鑑別品質管理体系所需的過程及其在組織中之運用見12B決定這些過程的順序及相互關係C決定確保這些過程有效運作及管制的必要的準則及方方法，D確保提供支援這些過程的運作及監督必要的資源與資訊；E量測、監控及分析這些流程，和F采取必要行動以達成這些過程預期的結果及持續改善組織應遵照本國際標準的要求管理這些過程當組織選用任何滿足產品與要求所需的外來資源流程時，組織應確認能掌控這些流程。品質管理体系之外來資源流程的控制應被定義。備註上述品質管理体系所須之過程包括管理活動、資源提供、產品實現與量測等過程。42文件化要求421通則品質管理体系文件應包括A品質政策及品質目標B品質手冊C本國際標準要求的文件化程序；D組織為確保其過有效規劃、運作及管制所需要的文件，及E本國際標準要求之記錄（見424）備註1本國際標準中出現名詞”文件化程序”之處，係要求該程序須被建立、文件化、實施及維持。備注2各組織其品質管理体系文件化程度或有差別，端賴下列而定A組織的規模及活動型態；B過程的複雜性及相互關係C員工的能力。備註3文件可能為任何形式或種類的媒體。422品質手冊組織應建立與維護品質手冊，其內容包含A品質管理体系的範圍，包括對排除部份的細節與理由見12B品質管理体系所建立的文件化程序，或參考該等程序，及C描述品質管理体系各過程的順序及其彼此間之相互關係423CONTROLOFDOCUMENTSDOCUMENTSREQUIREDBYTHEQUALITYMANAGEMENTSYSTEMSHALLBECONTROLLEDRECORDSAREASPECIALTYPEOFDOCUMENTANDSHALLBECONTROLLEDACCORDINGTOREQUIREMENTSGIVENIN424ADOCUMENTEDPROCEDURESHALLBEESTABLISHEDTODEFINETHECONTROLSNEEDEDATOAPPROVEDOCUMENTSFORADEQUACYPRIORTOISSUEBTOREVIEWANDUPDATEASNECESSARYANDREAPPROVEDOCUMENTSCTOENSURETHATCHANGESANDTHECURRENTVERISIONSTATUSOFDOCUMENTSAREIDENTIFIEDDTOENSURETHATRELEVANTVERSIONSOFAPPLICABLEDOCUMENTSAREAVAILABLEATPOINTSOFUSEETOENSURETHATDOCUMENTSREMAINLEGIBLEANDREADILYIDENTIFIABLEFTOENSURETHATDOCUMENTSOFEXTERNALORIGINAREIDENTIFIEDANDTHEIRDISTRIBUTIONCONTROLLED,ANDGTOPREVENTTHEUNINTENDEDUSEOFOBSOLETEDOCUMENT,ANDTOAPPLYSUITABLEIDENTIFICATIONTOTHEMIFTHEYARERETAINEDFORANYPURPOSE424CONTROLOFRECORDSRECORDSSHALLBEESTABLISHEDANDMAINTAINEDTOPROVIDEEVIDENCEOFCONFORMITYTOREQUIREMENTSANDOFTHEEFFECTIVEOPERATIONOFTHEQUALITYMANAGEMENTSYSTEMRECORDSSHALLREMAINLEGIBLE,READILYIDENTIFIABLEANDRETRIEVABLEADOCUMENTEDPROCEDURESHALLBEESTABLISHEDTODEFINETHECONTROLSNEEDEDFORTHEIDENTIFICATION,STORAGE,PROTECTION,RETRIEVAL,RETENTIONTIMEANDDISPOSITIONOFQUALITYRECORDS5MANAGEMENTRESPONSIBILITY51MANAGEMENTCOMMITMENTTOPMANAGEMENTSHALLPROVIDEEVIDENCEOFITSCOMMITMENTTOTHEDEVELOPMENTANDIMPLEMENTATIONOFTHEQUALITYMANAGEMENTSYSTEMANDCONTINUALLYIMPROVINGITSEFFECTIVENESSBYACOMMUNICATINGTOTHEORGANIZATIONTHEIMPORTANCEOFMEETINGCUSTOMERASWELLASSTATUTORYANDREGULATORYREQUIREMENTSBESTABLISHINGTHEQUALITYPOLICYCENSURINGTHATQUALITYOBJECTIVESAREESTABLISHEDDCONDUCTINGMANAGEMENTREVIEWS,ANDEENSURINGTHEAVAILABILITYOFRESOURCES52CUSTOMERFOCUSTOPMANAGEMENTSHALLENSURETHATCUSTOMERREQUIREMENTSAREDETERMINEDANDMETWITHTHEAIMOFENHANCINGCUSTOMERSATISFACTIONSEE721AND82153QUALITYPOLICYTOPMANAGEMENTSHALLENSURETHATTHEQUALITYPOLICYAISAPPROPRIATETOTHEPURPOSEOFTHEORGANIZATIONBINCLUDESACOMMITMENTTOCOMPLYWITHREQUIREMENTSANDCONTINUALLYIMPROVETHEEFFECTIVENESSOFTHEQUALITYMANAGEMENTSYSTEMCPROVIDESAFRAMEWORKFORESTABLISHINGANDREVIEWINGQUALITYOBJECTIVESDISCOMMUNICATEDANDUNDERSTOODWITHINTHEORGANIZATIONEISREVIEWEDFORCONTINUINGSUITABILITY54PLANNING541QUALITYOBJECTIVESTOPMANAGEMENTSHALLENSURETHATQUALITYOBJECTIVES,INCLUDINGTHOSE423文件管制品質管理体系所要求之文件應加以管制，記錄為一特殊型態之文件應依據424之要求加以管制。應建立文件化之程序用以管制A文件發行前，核准其正確性B審查必要的更新與再次核准文件C確定文件的最新版次狀態已被界定D確保文件的改變及目前版次次狀態被標明E確保使用各場所，持有相應版次的適當文件，F確保外來原始文件被識別及管制分發，和G防止作廢文件被誤用。如因任何目的而留存時，應被適當的鑑別424記錄的管制品質管理体系所須之記錄應被建立與維護，以証明符合品質管理体系要求的符合性及有效運作。品質紀錄應易於閱讀，識別及取用應建立文件化程序以定義紀錄的識別、儲存、取用、保護、保存期限儲與處置方式。5管理責任51管理承諾最高管理者應透過下列方式，以證明對其品質管理体系發展、實施與持續改善体系有效性之承諾A對組織內部溝通符合客戶及法令要求的重要性B建立品質政策C確保品質目標被建立D執行管理審查，和E確保必要資源的提供52以客戶為中心最高管理者應確保客戶之要求已被決定且滿足，以達到客戶滿意為目的見721及82153品質政策最高管理者應確保其品質政策A適合組織的目地B包括符合品質管理体系要求及持續改善体系有效性之承諾C提供一個建立及審查品質目標之體制D於組織中被溝通及了解E審查其持續的適切性54規劃541品質目標高階管理者應確保組織內各相關機能及各層級之品質目NEEDEDTOMEETREQUIREMENTSFORPRODUCTSEE71AAREESTABLISHEDATRELEVANTFUNCTIONSANDLEVELSWITHINTHEORGANIZATIONTHEQUALITYOBJECTIVESSHALLBEMEASUREDANDCONSISTENTWITHTHEQUALITYPOLICY542QUALITYMANAGEMENTSYSTEMPLANNINGTOPMANAGEMENTSHALLENSURETHATATHEPLANNINGOFTHEQUALITYMANAGEMENTSYSTEMISCARRIEDOUTINORDERTOMEETTHEREQUIREMENTSGIVENIN41,ASWELLASTHEQUALITYOBJECTIVES,ANDBTHEINTEGRITYOFTHEQUALITYMANAGEMENTSYSTEMISMAINTAINEDWHENCHANGESTOTHEQUALITYMANAGEMENTSYSTEMAREPLANNEDANDIMPLEMENTED55RESPONSIBILITY,AUTHORITYANDCOMMUNICATION551RESPONSIBILITYANDAUTHORITYTOPMANAGEMENTSHALLENSURETHATTHERESPONSIBILITIES,AUTHORITIESAREDEFINEDANDCOMMUNICATEDWITHINTHEORGANIZATION552MANAGEMENTREPRESENTATIVETOPMANAGEMENTSHALLAPPOINTAMEMBEROFTHEMANAGEMENTWHO,IRRESPECTIVEOFOTHERRESPONSIBILITIES,SHALLHAVERESPONSIBILITYANDAUTHORITYTHATINCLUDESAENSURINGTHATPROCESSESNEEDEDFORTHEQUALITYMANAGEMENTSYSTEMAREESTABLISHED,IMPLEMENTEDANDMAINTAINEDBREPORTINGTOTOPMANAGEMENTONTHEPERFORMANCEOFTHEQUALITYMANAGEMENTSYSTEMANDANYNEEDFORIMPROVEMENT,ANDCENSURINGTHEPROMOTIONOFAWARENESSOFCUSTOMERREQUIREMENTSTHROUGHTHEORGANIZATIONNOTETHERESPONSIBILITYOFAMANAGEMENTREPRESENTATIVECANINCLUDELIAISONWITHEXTERNALPARTIESONMATTERSRELATINGTOTHEQUALITYMANAGEMENTSYSTEM553INTERNALCOMMUNICATIONTOPMANAGEMENTSHALLENSURETHATAPPROPRIATECOMMUNICATIONPROCESSESAREESTABLISHEDWITHINTHEORGANIZATIONANDTHATCOMMUNICATIONTAKESPLACEREGARDINGTHEEFFECTIVENESSOFTHEQUALITYMANAGEMENTSYSTEM56MANAGEMENTREVIEW561GENERALTOPMANAGEMENTSHALLREVIEWTHEORGANIZATIONSQUALITYMANAGEMENTSYSTEM,ATPLANNEDINTERVALS,TOENSUREITSCONTINUINGSUITABILITY,ADEQUACYANDEFFECTIVENESSTHISREVIEWSHALLINCLUDEASSESSINGOPPORTUNITIESFORIMPROVEMENTANDTHENEEDFORCHANGESTOTHEQUALITYMANAGEMENTSYSTEM,INCLUDINGTHEQUALITYPOLICYANDQUALITYOBJECTIVESRECORDSFROMMANAGEMENTREVIEWSSHALLBEMAINTAINEDSEE424562REVIEWINPUTTHEINPUTSTOMANAGEMENTREVIEWSHALLINCLUDEINFORMATIONONARESULTSOFAUDITSBCUSTOMERFEEDBACKCPROCESSPERFORMANCEANDPRODUCTCONFORMITYDSTATUSOFPREVENTIVEANDCORRECTIVEACTIONSEFOLLOWUPACTIONSFROMPREVIOUSMANAGEMENTREVIEWSFCHANGESTHATCOULDAFFECTTHEQUALITYMANAGEMENTSYSTEM,ANDGRECOMMENDATIONSFORIMPROVEMENT563REVIEWOUTPUTTHEOUTPUTSFROMTHEMANAGEMENTREVIEWSHALLINCLUDEANY標被建立，品質目標包含符合產品要求之各項要求見71A品質目標應可被量測，且必須與品質政策相一致。542品質管理体系規劃高階管理者應確保A規劃品質管理体系以符合條文41節及品質止標之要求，和B當品質管理体系計劃將有或已有變化時，維持品質管理体系之完整性。55責任,授權與溝通551責任與授權高階管理者應確定組織內之責任、授權已被定義及溝通。552管理代表高階管理者應指派管理階層中之一員，不受其他責任影響，明定其責任與授權包含下列A確保品質管理体系所需之過程被建立、實施與維持B向高階管理者報告品質管理体系執行之成效及必要之改善C確保組織全員對客戶要求認知的提昇備註管理代表的責任可以包括與外部機構對品質管理体系有關事務的聯繫553內部溝通最高管理者應確保組織內之溝通過程已被建立,並且對於品質管理体系有效性進行溝通56管理審查561通則高階管理者應於事先計劃的間隔期間審查組織的品質管理体系,以確保其持續的適切性、正確性與有效性。管理審查應包括評估改善的機會與品質管理体系修正的必要性，包括政策與目標管理審查的記錄需加以維護參見424562管理審查輸入管理審查的輸入應涵蓋下列資訊A稽核的結果B客戶回饋C過程績效及產品符合性D各項矯正預防措施的狀態E前次管理審查決議事項的跟催F可能影響品質管理体系的變化,和G改善的建議563管理審查的輸出DECISIONSANDACTIONSRELATETOAIMPROVEMENTOFTHEEFFECTIVENESSOFTHEQUALITYMANAGEMENTSYSTEMANDITSPROCESSESBIMPROVEMENTOFPRODUCTRELATEDTOCUSTOMERREQUIREMENTS,ANDCRESOURCENEEDS6RESOURCEMANAGEMENT61PROVISIONOFRESOURCESTHEORGANIZATIONSHALLDETERMINEANDPROVIDETHERESOURCESNEEDEDATOIMPLEMENTANDMAINTAINTHEQUALITYMANAGEMENTSYSTEMANDCONTINUALLYIMPROVEITSEFFECTIVENESS,ANDBTOENHANCECUSTOMERSATISFACTIONBYMEETINGCUSTOMERREQUIREMENTS62HUMANRESOURCES621GENERALPERSONNELPERFORMINGWORKAFFECTINGPRODUCTQUALITYSHALLBECOMPETENTONTHEBASICOFAPPROPRIATEEDUCATION,TRAINING,SKILLSANDEXPERIENCE622COMPETENCE,AWARENESSANDTRAININGTHEORGANIZATIONSHALLADETERMINETHENECESSARYCOMPETENCYFORPERSONNELPERFORMINGWORKAFFECTINGPRODUCTQUALITYBPROVIDETRAININGOFTAKEOTHERACTIONSTOSATISFYTHESENEEDSCEVALUATETHEEFFECTIVENESSOFTHEACTIONSTAKENDENSURETHATITSPERSONNELAREAWAREOFTHERELEVANCEANDIMPORTANCEOFTHEIRACTIVITIESANDHOWTHEYCONTRIBUTETOTHEACHIEVEMENTOFTHEQUALITYOBJECTIVES,ANDEMAINTAINAPPROPRIATERECORDSOFEDUCATION,TRAINING,SKILLSANDEXPERIENCESEE42463INFRASTRUCTURETHEORGANIZATIONSHALLDETERMINE,PROVIDEANDMAINTAINTHEINFRASTRUCTURENEEDEDTOACHIEVECONFORMINGTOPRODUCTREQUIREMENTSINFRASTRUCTUREINCLUDES,ASAPPLICABLEABUILDINGS,WORKSPACEANDASSOCIATEDUTILITIESBPROCESSEQUIPMENT,BOTHHARDWAREANDSOFTWARE,ANDCSUPPORTINGSERVICESSUCHASTRANSPORTORCOMMUNICATION64WORKENVIRONMENTTHEORGANIZATIONSHALLDETERMINEANDMANAGETHEWORKENVIRONMENTNEEDEDTOACHIEVECONFORMITYOFPRODUCTREQUIREMENTS7PRODUCTREALIZATION71PLANNINGOFREALIZATIONPROCESSESTHEORGANIZATIONSHALLPLANANDDEVELOPTHEPROCESSESNEEDEDFORPRODUCTREALIZATIONPLANNINGOFTHEPRODUCTREALIZATIONPROCESSESSHALLBECONSISTENTWITHTHEOTHERREQUIREMENTSOFTHEQUALITYMANAGEMENTSYSTEMSEE41INPLANNINGFORPRODUCTREALIZATION,THEORGANIZATIONSHALLDETERMINETHEFOLLOWING,ASAPPROPRIATEAQUALITYOBJECTIVESANDREQUIREMENTSFORTHEPRODUCTBTHENEEDTOESTABLISHPROCESSES,DOCUMENTATION,ANDPROVIDERESOURCESSPECIFICTOTHEPRODUCTCREQUIREDVERIFICATION,VALIDATION,MONITORING,INSPECTIONANDTESTACTIVITIESSPECIFICTOTHEPRODUCT,ANDTHECRITERIAFORPRODUCTACCEPTANCEDRECORDSNEEDEDTOPROVIDEEVIDENCETHATTHEREALIZATIONPROCESSESANDRESULTINGPRODUCTMEETREQUIREMENTSSEE424管理審查的輸出應包括下列各項的決議與行動A品質管理体系及各過程有效性的改善B與客戶要求有關的產品改善C資源的要求6資源管理61資源的提供組織應決定與提供必須的資源，以A執行和維護品質管理体系及持續改善其有效性，和B籍由符合客戶要求以增進客戶滿意62人力資源621通則人員從事足以影響產品品質之工作,必須依其適當的教育、訓練、技能和經歷以勝任其工作622資格、認知與訓練組織應A界定從事足以影響產品品質者之資格要求B提供訓練或其他措施以滿足這些要求C評估所采取措施的有效性D確保員工認知本身作業的相關性與重要性及其對達成品質目標的貢獻,和E維護適當的教育、訓練、技能及經驗的紀錄見42463基礎設施組織應決定、提供及維護為達成符合產品要求必要的基楚設施，基楚設施包括可行的下列A建築物、工作空間及附屬的設施B過程設備包括軟、硬體設備,和C支援服務例如運輸、通訊64工作環境組織應決定和管理為達到符合產品要求的工作環境，7產品實現71產品實現的規劃組織應規劃與展開產品實現所需要的各項過程,產品實現過程的規劃必須與品質管理体系其他過程的要求相一致在規劃產品實現過程時，組織必須適當決定下列要項A品質目標和產品要求B針對產品所需過程、文件及資源的提供C針對產品必要的驗證、確認、監控、檢驗與測試的活動及產品的允收標準D必要的記錄以証明產品實現過程與最終產品符合要求THEOUTPUTOFTHISPLANNINGSHALLBEINAFORMSUITABLEFORTHEORGANIZATIONSMETHODOFOPERATIONSNOTE1ADOCUMENTSPECIFYINGTHEPROCESSESOFTHEQUALITYMANAGEMENTSYSTEMINCLUDINGTHEPRODUCTREALIZATIONPROCESSESANDTHERESOURCESTOBEAPPLIEDTOSPECIFICPRODUCT,PROJECTORCONTRACT,CANBEREFERREDTOASAQUALITYPLANNOTE2THEORGANIZATIONMAYALSOAPPLYTHEREQUIREMENTSGIVENIN73TOTHEDEVELOPMENTOFPRODUCTREALIZATIONPROCESSES72CUSTOMERRELATEDPROCESSES721DETERMINATIONOFREQUIREMENTSRELATEDTOTHEPRODUCTTHEORGANIZATIONSHALLDETERMINEAREQUIREMENTSSPECIFIEDBYTHECUSTOMER,INCLUDINGTHEREQUIREMENTSFORDELIVERYANDPOSTDELIVERYACTIVITIESBREQUIREMENTSNOTSTATEDBYTHECUSTOMERBUTNECESSARYFORSPECIFIEDORINTENDEDUSE,WHEREKNOWN,CSTATUTORYANDREGULATORYREQUIREMENTSRELATEDTOPRODUCT,ANDDANYADDITIONALREQUIREMENTSDETERMINEDBYTHEORGANIZATION722REVIEWOFREQUIREMENTSRELATEDTOTHEPRODUCTTHEORGANIZATIONSHALLREVIEWTHEREQUIREMENTSRELATEDTOTHEPRODUCTTHISREVIEWSHALLBECONDUCTEDPRIORTOTHEORGANIZATIONSCOMMITMENTTOSUPPLYAPRODUCTTOTHECUSTOMEREGSUBMISSIONOFTENDERS,ACCEPTANCEOFACONTRACTORORDERS,ACCEPTANCEOFCHANGESTOCONTRACTSORORDERSANDSHALLENSURETHATAPRODUCTREQUIREMENTSAREDEFINEDBCONTRACTORORDERREQUIREMENTSDIFFERINGFROMTHOSEPREVIOUSLYEXPRESSEDARERESOLVED,ANDCTHEORGANIZATIONHASTHEABILITYTOMEETDEFINEDREQUIREMENTSRECORDSOFTHERESULTSOFTHEREVIEWANDACTIONSARISINGFROMTHEREVIEWSHALLBEMAINTAINEDSEE424WHERETHECUSTOMERPROVIDESNODOCUMENTEDSTATEMENTOFREQUIREMENT,THECUSTOMERREQUIREMENTSSHALLBECONFIRMEDBYTHEORGANIZATIONBEFOREACCEPTANCEWHEREPRODUCTREQUIREMENTSARECHANGED,THEORGANIZATIONSHALLBEENSURETHATRELEVANTDOCUMENTSAREAMENDEDANDTHATRELEVANTPERSONNELAREMADEAWAREOFTHECHANGEDREQUIREMENTSNOTEINSOMESITUATIONSSUCHASININTERNETSALES,AFORMALREVIEWISIMPRACTICALFOREACHORDERINSTEADTHEREVIEWCANCOVERRELEVANTPRODUCTINFORMATIONSUCHASCATALOGUESORADVERTISINGMATERIAL723CUSTOMERCOMMUNICATIONTHEORGANIZATIONSHALLDETERMINEANDIMPLEMENTEFFECTIVEARRANGEMENTSFORCOMMUNICATIONWITHCUSTOMERSINRELATIONTOAPRODUCTINFORMATIONBENQUIRIES,CONTRACTSORORDERHANDLING,INCLUDINGAMENDMENTSCCUSTOMERFEEDBACK,INCLUDINGCUSTOMERCOMPLAINTS73DESIGNANDDEVELOPMENT731DESIGNANDDEVELOPMENTPLANNINGTHEORGANIZATIONSHALLPLANANDCONTROLDESIGNANDDEVELOPMENTOFPRODUCTDURINGTHEDESIGNANDDEVELOPMENTPLANNING,THEORGANIZATIONSHALLDETERMINEATHEDESIGNANDDEVELOPMENTSTAGESBTHEREVIEW,VERIFICATIONANDVALIDATIONTHATAREAPPROPRIATETOEACHDESIGNANDDEVELOPMENTSTAGE,ANDCTHERESPONSIBILITIESANDAUTHORITIESFORDESIGNANDDEVELOPMENT見424此項規劃產出的結果,其格應適合其組織作業方法。備註1針對特定產品、專案或合約用以描述其品質管理体系所有過程包括產品實現過程及所需資源的書面文件,可被稱為品質計劃備注2組織亦可運用條文73的要求於產品實現過程的展開。72顧客相關的過程721決定產品相關的要求組織應決定A顧客已指明的要求，包括對交貨與售后的要求B非顧客所明確指定，但對於已知特定或使用目的是必要的要求C與產品相關法令及法規的要求,和D組織自訂的任何額外要求722產品相關要求的審查組織應審查產品相關的要求此項審查應該在向客戶承諾提供產品之前完成即提出標單,接受合約或訂單,接受合約或訂單的變更並且確保A產品的要求已被定義B）合約或其他要求與先前表達有所不同處已被解決C組織有能力滿足各項已定義的要求審查結果及後續措施的紀錄必須加以維持（見424）當客戶提出非文件化的要求時，組織在接受客戶要求前應加以確認。當產品要求被改變時，組織應確保相關文件被修正，及相關人員都知道改變後的要求備註在某些情況下,例如網際行銷，對每一張訂單進行正式審查並不實際取代的方式可以是對相關產品的資訊例如型錄、廣告等加以審查。723客戶溝通組織應決定及實施有效的安排,以進行下列與客戶有關的溝通A產品資訊B詢價，合約或訂單的處理及修改,和E客戶回饋，包括客戶抱怨73設計與/或開發731設計與/或開發規劃組織須規劃和管制產品的設計開發活動在設計與開發規劃時,組織必須決定A設計開發過程的各階段B適合於各設計開發階段的審查,驗證和確認活動,和THEORGANIZATIONSHALLMANAGETHEINTERFACESBETWEENDIFFERENTGROUPSINVOLVEDINTHEDESIGNANDDEVELOPMENTTOENSUREEFFECTIVECOMMUNICATIONANDCLEARASSIGNMENTOFRESPONSIBILITIESPLANNINGOUTPUTSHALLBEUPDATED,ASAPPROPRIATE,ASTHEDESIGNANDDEVELOPMENTPROGRESSES732DESIGNANDDEVELOPMENTINPUTSINPUTSRELATINGTOPRODUCTREQUIREMENTSSHALLBEDETERMINEDANDRECORDEDMAINTAINEDSEE424THESESHALLINCLUDEAFUNCTIONALANDPERFORMANCEREQUIREMENTSBAPPLICABLESTATUTORYANDREGULATORYREQUIREMENTSCWHEREAPPLICABLE,INFORMATIONDERIVEDFROMPREVIOUSSIMILARDESIGNS,ANDDOTHERREQUIREMENTSESSENTIALFORDESIGNANDDEVELOPMENTTHESEINPUTSSHALLBEREVIEWEDFORADEQUACYREQUIREMENTSSHALLBECOMPLETE,UNAMBIGUOUSANDNOTINCONFLICTWITHEACHOTHER733DESIGNANDDEVELOPMENTOUTPUTSTHEOUTPUTSOFTHEDESIGNANDDEVELOPMENTSHALLBEPROVIDEDINAFORMTHATENABLESVERIFICATIONAGAINSTTHEDESIGNANDDEVELOPMENTINPUTSSHALLBEAPPROVEDPRIORTORELEASEDESIGNANDDEVELOPMENTOUTPUTSHALLAMEETTHEINPUTREQUIREMENTSFORDESIGNANDDEVELOPMENTBPROVIDEAPPROPRIATEINF