IRIS體系審核時的評分方法

IRIS體系審核時的評分方法Totalquestions:255,including12K.O.questions?？偣?55個問題，其中包括 12個K.O.問題1.Knock-out(K.O.)questions關(guān)鍵性問題2.Openquestionswhichareassessedthroughafourlevelapproachforassessingthelevelofmaturityofprocessesandthegrade/eXtenSionofimplementation(Optimized，Qualified，Defined，Poor)開放式問題：通過在審核時評分過程的成熟程度和實(shí)施的程度，設(shè)定了四種不同級別(優(yōu)秀，合格?？梢??？? 。3.Closedquestions0Yes/No)withoutprogressivematuritylevels。封閉式問題：只有滿足 /不滿足，沒有遞進(jìn)的成熟度級別。Note：QUeStiOnSindicatedas‘Nonapplicable’O'NA'Oarenotassessedandrelevantjustificationshallbedocumentedθ注：如果問題被指明為“不適用”0即 NAO,這些問題將不會被審核，但要說明“不適用”的原因，并OOOOOOknockoutquestions0K.O.O關(guān)鍵性問題0K.O.問題O：AdetailedpreassessmentoftheKnockOutOK.O.OquestionsshallbecarriedouttoascertainthereadinesstoundertaketheauditO對K.O.問題應(yīng)逐條進(jìn)行預(yù)審核，以確定能否開始正式的審核。FulfilmentisconsideredasaprerequisiteforIRIScertificationO滿足K.O.問題的要求是開始 IRIS認(rèn)證的前提條件。K.O.questionsarenotscoredOK.O.問題不打分。WhenaK.O.requirementisnotmet,thewholeauditfailsOTheCertificationprocesshastostartwithanewrequestOcoveringthefullauditprocessagain)O一旦K.O.問題沒有滿足，將不能通過審核。組織需要重新遞交認(rèn)證申請0審核過程將重新覆蓋所有要素OOK.O.問題一共120,00 2個只適用于信號系統(tǒng)的公司OQualityManagementSystem-GeneralrequirementsOOOOOO一通用要求Incaseoftransferoroutsourcingofactivitywiththeexecutionofacontractdoesatransferprocedureincluding：feasibilitystudy,nskanalysis,planning,communicationtocustomerandFALstotheappropriatelevelexist?當(dāng)合同執(zhí)行過程中有轉(zhuǎn)讓或者外包的情況發(fā)生，是否有轉(zhuǎn)讓的程序？其內(nèi)容包括： 可行性研究，風(fēng)險分口，策劃，客戶溝通和首件檢驗(yàn)，這些內(nèi)容有在適當(dāng)?shù)乃缴蠁幔緿esignanddevelopmentsForSignallingonly）設(shè)計(jì)和開發(fā)（僅適用于信號系統(tǒng)口DoestheorganizationapplytheprinciplesindevelopinghighintegritySysteminlinewiththeCENELECstandardorotheragreedequivalentmodels?ThesoftwaredesignprocessmustexplicitlyimplementtherequirementsofEN50128relatedtosafetyintegrityoftheintendedscopeoftheIRIScertificate。組織在開發(fā)高集成系統(tǒng)時是否應(yīng)用在 CENELEC標(biāo)準(zhǔn)或其它協(xié)議的等效標(biāo)準(zhǔn)?軟件開發(fā)過程必須實(shí)施EN50128的要求（與 IRIS證書范圍的安全集成有關(guān)時） 。CENELEC-Europeancommitteeforelectro-technicalstandardization歐洲電工技術(shù)標(biāo)準(zhǔn)委員會Designanddevelopmentinputs設(shè)計(jì)和開發(fā)輸入Doestheorganizationensurenewtechnologies/newproductsarevalidatedbeforebeingintroducedinacustomerproject?組織是否確保新技術(shù) /新產(chǎn)品在引入顧客項(xiàng)目前得到確認(rèn)？Designanddevelopmentvalidation設(shè)計(jì)和開發(fā)確認(rèn)Doestheorganizationensurethatreports,calculation,testresults,etc,demonstratethattheproductdefinitionmeetsthespecificationrequirementsforalltherelevantoperationalconditions?組織是否確保報(bào)告、計(jì)算、測試結(jié)果等能夠展示產(chǎn)品定義滿足所有相關(guān)的運(yùn)行條件的規(guī)范要求？DesignapprovalθForSignallingonly□設(shè)計(jì)批準(zhǔn)（僅僅適用于信號系統(tǒng)口DoestheorganizationprovideadocumentedproceduredefiningthesafetycaseandapprovalinlinewiththisStandard?組織是否準(zhǔn)備了文件化的程序，用于按照這個標(biāo)準(zhǔn)要求明確安全情況和批準(zhǔn)？Validationofprocessesforproductionandserviceprovision生產(chǎn)和服務(wù)提供過程的確認(rèn)Arespecialprocessedmanagedaccordingtothecontractualrequirements?00000000合同要求進(jìn)行管理 ？ProjectManagement項(xiàng)目管理Doestheorganizationimplementadocumentedprojectmanagement（PM）approachorSystem,ornewproductdevelopmentprocessaddressingtheapplicableareasofPM,describingrolesandresponsibilities,integratingthewholefunctionsoftheorganizationinamultidisciplinaryteam□組織是否實(shí)施項(xiàng)目管理方法或體系，或新產(chǎn)品開發(fā)過程，涉及項(xiàng)目管理的使用領(lǐng)域，描述職責(zé)和任務(wù)，整合組織內(nèi)所有相關(guān)職能形成多功能小組？Qualitymanagement質(zhì)量管理Doestheorganizationensurethattheprocessisinplacetomanageprojectdeliverables?組織是否確保有過程來管理項(xiàng)目是可以交付的？Changemanagement變更管理Areverification，validationANDAPPROVAL，activitiesdefined，toensurecompliancewithcustomerrequirementsBEFOREIMPLEMENTATION？在實(shí)施前，是否定義了驗(yàn)證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求？Firstarticleinspection]FAI）首件檢驗(yàn)DoestheorganizationsSystemprovideadocumentedproceduredefininginspection,verificationanddocumentationofarepresentativeitemfromthefirstserialproductionrunofanewpartorfollowinganysubsequentchangethatinvalidatesthepreviousfirstarticleinspectionresult?Note：iftheproductisaone-offorasoftware,FAIismeantasvalidation組織的體系是否有文件化的程序， 規(guī)定在新零件首次批量生產(chǎn)時 （或任何隨后的會導(dǎo)致先前的首件檢驗(yàn)結(jié)果失效的變更引入時）代表性零件的檢驗(yàn)、驗(yàn)證和文件化？注：如果產(chǎn)品僅是一個或是軟件 ，F(xiàn)AI就是指得是確認(rèn)。Commissioning/Customerservice測試/客戶服務(wù)Doestheorganizationprovideaprocessforfieldservices/Dofieldprocessesprovide：actionstobetakenwhereproblemsareidentifiedafterdelivery,includinginvestigation,reportingactivitiesandactionsorserviceInformationO組織是否有現(xiàn)場服務(wù)的過程?現(xiàn)場服務(wù)過程是否提供，在交付后，當(dāng)發(fā)現(xiàn)問題時，要采取相應(yīng)的措施，包括調(diào)查，報(bào)告活動和服務(wù)信息的措施？Controlofnonconformingprocesses不合格過程的控制Intheeventofbusinessmanagementprocessvariation,doestheorganizationhaveaprocessinplaceto；Identifyandrecordthevariation,andifthebusinessmanagementprocessisnon-conformtotakeappropriateactiontotcorrectthenonconformingprocess?Evaluatewhetherthebusinessmanagementprocessvariationhasresultedinproductnonconformity?Identifyandcontrolthenon-conformingproduct]當(dāng)發(fā)生過程偏差時，組織是否有過程來： a）識別，記錄偏差并采取適當(dāng)行動，糾正不合格的過程， b）00000000000口產(chǎn)品不合格，并且 C）識別并控制不合格的產(chǎn)品？Qualitymanagement/質(zhì)量管理Doestheorganizationensurethataprocessisinplacetomanageprojectdeliverables?組織是否確保有過程來管理項(xiàng)目是可以交付的？Theorganizationhasastructured,appropriateprojectrelatedqualitysysteminplacewithmanuals,proceduresandqualityplanstomanageprojectdeliverables組織有結(jié)構(gòu)化的、合適的與項(xiàng)目有關(guān)的質(zhì)量體系，包括手冊、程序和質(zhì)量計(jì)劃來管理項(xiàng)目是可以交付的。Changemanagement/變更管理Areverification，validationANDAPPROVALactivitiesdefined，toensurecompliancewithcustomerrequirementsBEFOREIMLEMENTATION？在變更實(shí)施前，是否定義了驗(yàn)證，確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求？Verification!]validationandapprovalactivitiesaredefinedtoensurecompliancewithcustomerrequirementsBEFOREIMPLENMTSTION]Processimplementedandrecordsareavailable在變更實(shí)施前。定義了驗(yàn)證、確認(rèn)和批準(zhǔn)活動，以確保符合顧客要求。過程得到了實(shí)施并有記錄。OpenQuestionsOOOOOOEachindividualrequirementθquestionθshallbescoredprogressivelyusingmaturitylevelsθ每項(xiàng)要求吐個問題）將按照成熟度級別被評分。Maturitylevelsandrelevantexpectedevidencesshallbeinterpretedconsistentlywithauditscopeandcompanycharacteristicsθ等級的評定依據(jù)和相關(guān)的審核發(fā)現(xiàn)必須是一致的。MaturityLevel成熟度級別 Istherequirementmet?是否滿足要求? Point分?jǐn)?shù) “Optimized”優(yōu)秀Exceededandcontinuouslyimproved4“qualified”合格Exceeded超過要求J “defined”滿足Metinfull達(dá)到要求 _2 “poor”差Partiallymet00000求1“insufficient”不滿Notmet00000O Compliance