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9.Auditchecklist(稽核项目),,,,,,,Page_of_,Page2of8,
No.(序号),ClassIItem(一级项目),ClassIIItem(二级项目),No.(序号),DetailItem(具体项目),"ISOItemNo.
(ISO条款)",Audited2/0(是否审核此项),DoneY/N(是否做此项),Score(得分),"Remarks
(备注)"
1,QualitySystem(质量体系),QualityManual(质量手册),1.1,"Hasthesupplierdefinedanddocumenteditscorporatequalitypolicy,objectivesandcommitmentstoquality?公司是否有文件定义来证明它的质量方针和目标及品质承诺?",4.2.1,2,,,
,,"DocumentControl
(文件控制)",1.2,Areallthequalitydocumentsreviewedandapprovedforadequacybyauthorizedpersonnelpriortoissue?质量文件发行前是否经过相应权责人员的审核和批准?,4.2.3,2,,,
,,,1.3,"Isthereanadequatesystemtocontroldocumentsandensurethattheyarelegible,identified,reviewed,authorized,up-to-dateanddistributed?是否有一个适用的文件管控系统,并确保它们容易的识别,审核,批准,最新的和分发?",4.2.3,2,,,
,,,1.4,"Isthereanadequateanddocumentedsystemforreceivingexternaldocumentssuchaspurchaseorders,customerspecs,drawings,procedures,regulationsandstandardsandisthereadequaterevisioncontrolforthesedocuments?是否有适当的证据说明,有对外部文件如客户的订单、标准、图样、程序,规章和标准等文件及其版本的控制?",4.2.3,2,,,
,,,1.5,Arealltherecordsofqualitystoredinextensolandsearchedeasilythatitismaintainedandneatentermly?是否所有质量记录保存完好、易于检索,并且定期维护整理?,4.2.4,2,,,
,,"Training
(培训)",1.6,Doesthesupplierestablishedthetrainingplanforhumanresourcewithintheorganization?公司是否制订了组织内部人力资源培训计划?,6.2.1,2,,,
,,,1.7,"Isthereasystemthatidentifiesanddefinestrainingrequirementsforallpersonnelaffectingthequalityoftheproduct?
对影响产品质量工作的人员是否进行识别并明确培训需求?",6.2.2,2,,,
2,"Responsibility
(职责)",QualityPlanning(质量策划),2.1,IstheOrganizationStructureChartaccordantwiththekeyprocessesofQMS?公司组织架构是否与质量管理体系中关键过程相一致?,5.4.2,2,,,
,,,2.2,HasthesupplierdisassembletheobjectivesofqualityintoeachDept.?对质量目标是否分解到各个部门?,5.4.1,2,,,
,,,2.3,"Aretheobjectivesofqualitymensurableaswellascontinuousimprovement?
质量目标是否可测量,并能保持持续改善?",5.4.1,2,,,
,,,2.4,DoessupplierestablishwhichchannelofcommunicationtoQMSwithintheorganization?对质量管理体系在组织内部建立了那些沟通渠道?,5.5.3,2,,,
,,,2.5,"Couldthesupplierensurethattheinformationofcustomerisproperlycommunicatedwithintheorganizationintime?
能否保证客户相关信息在组织内部的适当并且及时沟通?",5.5.3,2,,,
,,SystemReview(体系评审),2.7,"Hasthesupplierestablishedauditplanningandchecklistwheninternalaudits?
内部质量审核时是否制定了具体审核计划和检查表?",8.2.2,2,,,
,,,2.9,"Doesthemanagementpersonnelresponsilbefortheareataketimelycorrectiveactiononthedeficienciesbefoundbytheinternalauditor?
在内部质量稽核过程中发现的不足,权责部门的管理者能否及时采取纠正措施?",8.5.2,2,,,
,,,2.10,"Doesthesupplierconductmanagementreviewsatappropriateintervalsforthesuitabilityandeffectivenessofthequalitymanagementsystem?
是否定期对质量管理体系的有效性和适宜性进行管理评审?",5.6.1,2,,,
,,,2.11,Aretheinputstomanagementreviewsincludedresultsofaudits、customerfeedback、processperformanceandfollow-upactionsfrompreviousmanagementreviews?管理评审的输入是否包括审核结果、顾客反馈、过程业绩以及以往管理评审的实施状况?,5.6.2,2,,,
,,,,,,,Page_of_,Page3of8,
3,"MeasuringandTestingDevices
(测量和检测设备)","Controlof
EnvironmentDeviecs(环境设施控制)",3.1,"Doesthesupplieridentifytheworkenvironmentneededtoachieveconformitytoproductrequirements?(Production,WarehouseandInspectionarea).
对产品符合要求所需的工作环境是否进行识别?",6.3,2,,,
,,,3.2,Doesthefactoryhaveaseparateinspectionroomwithappropriatetasklightingandinspectiontable?是否有一个单独检查场所,配备适当的照明和检验桌台?,6.4,2,,,
,,,3.3,"Hasthesupplierappliedthe6Smanagement,andhowaboutaretheeffects?
是否推行6S管理,6S实施效果如何?",6.4,2,,,
,,"MeasureSystem
(量测体系)",3.4,"Isthereadetailedprocedureforverifiedandcalibratedtotestequipments?
对测量设备的校验和校准是否制定相关管理程序?",7.6,2,,,
,,,3.5,"Becalibratedorverifiedatspecifiedintervals,orpriortouse,againstmeasurementstandardstraceabletointernationalornationalmeasurementstandards.
对照能溯源到国际或国家标准的测量标准,按照规定的时间间隔或在使用前进行校准或验证.",7.6a),2,,,
4,ProductDesignandDevelopment(产品设计和开发),"DevelopmentFlow
(研发流程)",4.1,"Isthereprocedurestoregulatedforcontrollingandverifyingthedesignofproduct,toensureallrequirementsaremet?
是否有程序规定去控制和验证产品设计,以保证符合所有的要求?",7.2.17.3.2,2,,,
,,,4.2,ArealltheQualityPlansofproductconstitutedthatincludedqualityobjectivesandqualityrequirmentsofproduct?是否制定产品质量计划,包括产品的质量目标和质量要求?,7.1,2,,,
,,,4.3,"Doesthesupplierspecifiedreviews,verification,validationofdesignanddevelopmentinprocedures?新产品研发的评审、验证、确认过程是否得到明确规定?",7.3.14.2.3,2,,,
,,,4.4,"Doesthesuppliertestthesamplesoftheirvendortoapprove?
对零部件供方的送样是否进行测试承认?",7.4.17.4.3,2,,,
,,"DesignandDevelopmentOutputs
(开发设计输出)",4.5,AretheDesignanddevelopmentoutputsincludedfunctionalandperformanceandit'sapproved?产品设计开发输出文档是否包括功能性能说明并经过审批?,7.3.3,2,,,
,,,4.6,Doesthesupplierspecifiedthecharacteristicsoftheproductthatareessentialforitssafeandproperuse?是否对产品的安全和正常使用所必须的产品特性作出规定?,7.3.47.3.54.2.4,2,,,
,,,4.7,"Aretheproductstestedtoensurespecsofthedesignaremetpriortomassproduction,therecordsaremaintainedandapproved?
量产前是否检验产品符合设计规格的要求(如设计评审/确认),并形成记录得到审批?",7.3.5,2,,,
,,,4.8,Hasvalidationprocessofproductperformedinaccordancewithplanedarrangementsofthedesignanddevelopment?对产品的验证确认过程是否符合产品设计开发策划的安排?,7.4.1,2,,,
,,"ECN
工程变更",4.9,Isthereaprocedurethatidentifieschangesfordesignandengineeringanditisreviewedandapprovedby?对于设计/工程变更是否有识别、审批、批准的书面化程序?,7.3.74.2.3,2,,,
,,,4.10,AretheECNdistributedallaffecteddepartmentsthatit'sausterelyaccordingtoprescribedtimes?是否严格按照规定的时机发放ECN并及时传达到受影响的部门?,7.3.7,2,,,
,,,4.11,"Areallchangesofdesignandengineeringreviewedandapprovedbyauthorizedpersonnelbeforeimplementationandithasrecorded?
设计/工程变更在执行前是否经权责人员审批并形成记录?",7.3.74.2.4,2,,,
,,,4.12,AretheECNsignalledcustomertoapprovebeforeimplementation?ECN变更前是否通报给顾客同意后才实施?,7.2.27.2.3,2,,,
,,"Customer-RelatedProcesses
(与顾客有关的过程)",4.13,"Doesthesupplierreviewthecustomerrequirementsofchanges?
对顾客要求变更的内容是否进行评审?",7.2.24.2.4,2,,,
,,,4.14,Doesthesupplierrecordcontentsofcommunicationprocesseswithcustomerandthevalidityconfirmed?与顾客沟通的过程是否形成记录并对其有效性进行确认?,7.2.24.2.4,2,,,
,,,,,,,Page_of_,Page4of8,
5,ControlofPurchasingandSupplierManagement(采购和供方管理控制),SupplierManagement(供方管理),5.1,Hasthesupplierendorsedasonacontractofqualitytorestrictedbothresponsibilitiesandauthorities?是否与供方签定品质协议来约束双方责权?,7.4.1,2,,,
,,,5.2,Hastheeligiblelistofvendorbeenapprovedwhichisupdatedatappropriateintervals?合格供方名单是否经审批生效并定期更新?,7.4.14.2.4,2,,,
,,,5.3,Hasthesupplierassessedandrecordedperformanceoftheirvendoratappropriateintervals?是否定期对供方业绩进行考评并形成记录?,7.4.14.2.4,2,,,
,,,5.4,"Doesthesupplieraudittheirvendoratappropriateintervals?
是否定期对供方稽核?",7.4.1,2,,,
,,,5.5,"HasthesuppliercontinuallyadvancedandupgradedtheQualityobjectivestotheirvendor,andrequiredvendortodurativeimproved?
是否对供方提出不断提升的质量目标,并定期考评质量目标达成状况,并要求供方持续改善?",7.4.18.48.54.1f),2,,,
,,,5.6,"Hasthesupplieradoptedrelevantactiontoaccordingtotheachievementoftheirvendor(e.g.reducedorder、stoppedpurchasing、directedaudit)?
是否根据业绩考评结果对供方采取相应措施(如减少定单、停止采购、辅导监察等)?",7.4.14.2.4,2,,,
,,,5.7,Hasthesupplierrequiretheirvendortpdotestthattestifiedreliabilityandwearofproductatappropriateintervals?是否要求供方定期对产品进行试验以证明产品的可靠性、耐久性?,7.4.3,2,,,
,,ControlofPurchasing(采购控制),5.8,"ArethecomponentsofNotapprobatoryapprovedtourgentpurchasingpriortoimplementation?
对于紧急采购未经承认的零部件是否经审批后才实施?",7.4.24.2.3,2,,,
,,,5.9,Hasthesupplierestablishedtheplanningofdevelopmentfornewvendorandit'simplemented?是否制定新供方开发计划并执行?,7.4.1,2,,,
,,,5.10,"DoesthesupplieradoptenecessarycontrolWhentheirsupplierbreachacontract?
当供方违约是否对供方采取必需的控制?",7.4.18.5,2,,,
,,,5.11,"Hasthesupplierpreparedandapprovedthecondignpurchasingplan,andupdateditaccordingtorelevantrequirement?
是否制定批准适宜的采购计划并根据需要进行更新?",7.4.17.4.24.2.3,2,,,
6,"ControlofIn-comingMaterial
(来料控制)","ControlofIn-comingMaterial
(来料控制)",6.1,"Arethereworkinstructionsforanyproduct,isitunambiguousandclear?
针对每一种部品的检验是否都有作业指导书,作业指导书是否明确、清楚?",7.4.3,2,,,
,,,6.2,"Whennewmaterialonarrived,arethereSPECofcomponentsthatitisapprovedbyENGorRDDept?新物料到货时,是否具有工程或研发审批的部件承认书?",7.4.3,2,,,
,,,6.4,"Arethereclearspecforcheckwhenmaterialhavebeenchanged?
物料变更时是否有明确的检验依据?",7.5.1,2,,,
,,,6.5,Arethematerialscheckedbyalltheinspectorswhethertheywereaccordingtothecriterionofinspection?检查员是否按检验标准或规范进行检查?,7.5.1,2,,,
,,,6.6,"Havethesamplesofusedininspectionaffirmedandcontrolled?
检验使用的样品是否经过认证和处于受控状态?",7.6,2,,,
,,,6.7,Hasthesupplierassessedandtrainedtermlytoinspectorwhethertherearecleartrainingplan?对检查员是否考核和定期的培训,是否有明确的培训计划?,6.2.1,2,,,
,,,6.9,"Aretherethecalibratedstatusofinstrumentforusingwhethertheymeetrequirements?
检验用仪器校准状态是否符合使用要求?",7.6,2,,,
,,,,,,,Page_of_,Page5of8,
,,"ControlofNonconformingPart
(不合格物料处理)",6.10,"Arethererejectlotsthatitisconcededtoacceptedonthesuppliergoingtofallstandard,howdotheyapprove?是否有降低标准或让步接收不合格物料的情况,如何进行批准的?",8.3,2,,,
,,,6.11,ArethererejectlotswhethertheyareanalyzedandhaveCARbytherelevantdepartmentorsupplier?对不合格批次是否有相应部门或供应商的分析改善报告?,8.3,2,,,
,,,6.12,"Howtrackandaffirmarethecorrectiveandpreventiveactionofanalysisreprot?
对分析报告中的纠正和预防措施及其效果是如何跟踪、确认的?",8.3,2,,,
7,"Controlofproduction
(生产控制)",FlowofProduction(生产流程),7.1,HasthesupplierpreparedtheQCflow-chartorPMPthatisimplemented?是否制作QC工程图或PMP并依此作业?,7.5.17.3.3,2,,,
,,,7.2,"Hasthesupplierdefinedhowtodrawthematerialspriortoproduction?
生产开始时领料或者配料的依据是否明确?",7.3.3,2,,,
,,,7.3,"Doesthesupplieridentifystationofkeyandspecialtocontrol?
是否识别关键工序和特殊工序并加以控制?",7.5.24.2.4,2,,,
,,,7.4,"AreanystationofproductiondoneaccordingtotheWI?
每个生产工序是否有作业指导书并按规定作业?",7.5.1,2,,,
,,,7.5,Hasthesupplierestablishedcriterionforstopproductionandholdshipment?是否建立了停线和停止出货的标准?,8.2.38.5,2,,,
,,,7.6,Arealltheoperatorstrainedtopasstooperationthroughexaminationspeciallyonthestationofkeyandspecial?关键工序和特殊工序的作业员是否经过培训考核合格后上岗?,6.2.24.2.4,2,,,
,,,7.7,"Arealltheequipmentsforproductionwithinperiodofvalidity?
生产所使用的仪器设备是否处于检定、校验有效期内?",7.6,2,,,
,,,7.8,"Havethoseeligibleandsubstandardproductsbeenmarked?
对合格品、不合格品的状况是否明确标识?",7.5.3,2,,,
,,,7.9,"Arerawmaterialsarightstoredincontrolledareatoavoidloss,damage,deterioration?所有材料是否在受控区域正确存放避免混料或损坏?",7.5.5,2,,,
,,,7.10,Aretheallproductsoftestandnottestdetachedandadoptedpropermodetoavoidmix?所有通过/未通过测试的产品是否采取适当方式分开以避免混淆?,7.5.3,2,,,
,,"IPQC
(制程质量控制)",7.11,Hasthesuppliersetobjectivesofdefectiverateofprocessthatshallbeanalyseditsstatusmanaged?是否设定制程不良率目标并对目标达成状况进行分析确认?,8.3,2,,,
,,,7.12,"AreanalysisandappropriateactionstakeniftheCp/Cpkvaluesorcontrolchartarenotmeetingexpectation?
当管制图超出管制界限或CP/CPK值(没有达到期望值时)是否进行原因分析和改善对策?",7.18.2.38.48.5,2,,,
,,,7.13,DoestheIPQC(QualityControl)performseparatelyfromtheProductiondepartmentandrecordsaredone?IPQC是否执行巡查检验并进行记录?,7.18.2.4,2,,,
,,,7.14,Doesthesuppliercheckthefirstproductwhenproductlineorshiftischanged?生产开始/生产换班时、换产品线时,是否进行首件确认?,7.18.2.4,2,,,
,,,7.15,Hasthesuppliercheckedandmaintainedtheequipmentthatrecordsaremaintained?是否对设备进行点检、保养并保持记录?,7.64.2.4,2,,,
,,,7.16,"DoesthesupplierperformedtheECNaccordingtoprocedure?
是否依规定ECN执行工程变更?",7.5.1,2,,,
,,,7.17,Hasthesupplierdefinedhowtoextendtheexceptionalrequisitionofquality?Doesthesuppliertodoaccordingtoit?对发放质量异常通知单的条件是否充分定义并按规定实施?,7.18.2.3,2,,,
,,,7.18,DoesthesupplierinspectproductaccordingtodrawingandspecorFARofcustomer?是否依据客户提供之产品图纸规格及材料承认书或FAR进行检验?,8.3,2,,,
,,,,,,,Page_of_,Page6of8,
,,Cotrolofproductinspection(成品检验控制),7.19,"Arealltheproductsofshipmentpassedthattheyareinextensocheckedandtested?
是否每批产品都经过完整的检验、试验合格后才放行?",8.2.4,2,,,
,,,7.20,"Arealltheinspectorsofstationpassedthattheyaretrainedandexamined?
检查员是否经培训考核合格后上岗?",6.2.24.2.4,2,,,
,,,7.21,"Hasthesuppliermarkedtheproductinprocess?
检验过程中产品状态标识是否明确?",7.5.3,2,,,
,,,7.22,"Aretheprocessofproductiontraceability,andhowtotraced?
对产品生产过程是否可追溯,如何追溯的?",7.5.3,2,,,
,,,7.23,Hasthesupplierconstitutedre-workflow?Wasitincludedprocessofinspection?对批退之成品,是否有制定重工流程,且重工执行完整的检验试验过程?,6.2.24.2.4,2,,,
,,,7.24,DoesthesupplierinspectproductaccordingtodrawingandspecorFARofcustomer?是否依据客户提供之产品图纸规格及材料承认书或FAR进行验货?,8.34.2.3,2,,,
,,,7.25,"DosethesuppliertheCARwhendefectiveproductisfound,whichamendatoryactionsweretrackedandvalidatedtoeffect?
针对所发现的不良有否发行CAR,并对改善对策进行跟踪验证?",8.38.5,2,,,
,,,7.26,"DoesthesupplieranalyseforstatusofOQAobjectivesmanaged?
是否对成品检验目标达成状况进行分析?",7.18.44.2.4,2,,,
,,,7.27,Istheconcessionapprovedtoforfailurelotsbyauthorizedpersonnel?让步放行出货是否经权责人员批准?,8.2.44.2.4,2,,,
,,,7.28,"Arealltherecordsofcheckoutstored,andeasytosearch?
是否保存检验纪录,且便于查询?",7.5.2,2,,,
,,"ControlofDie
(模具控制)",7.29,"Hasthesupplierdefinedlifetousedfordiewithfile?
对模具使用寿命(或者使用次数)是否有书面规定?",7.5.14.2.3,2,,,
,,,7.3,"Wasthediemetlifeofused?
模具是否在使用寿命之内?",4.2.4,2,,,
,,,7.31,"Arethereaprocedurefordietoberepairedandchanged?
模具的修理及变更是否有规定?",7.5.14.2.3,2,,,
,,,7.32,"Hasthesuppliercheckedandmaintainedthosedies?andrecordsmaintained?
模具的维护保养是否进行按照规定进行,记录保留是否完整?",7.5.14.2.4,2,,,
,,,7.33,"Arethereamarkingonthedie,andconvenientfortracing?
模具上有无相应编码等标记便于追溯?",7.5.3,2,,,
8,"WarehouseManagementandFenseProduct
(资材管理和产品防护)",StorageProduct(产品贮存),8.1,"Arethereproceduresforhandling,storing,packaginganddeliveryofproduct?
是否制定产品搬运、贮存、包装和交付管理办法?",7.5.5,2,,,
,,,8.2,"ArethematerialsissuedaccordingtoFIFO,andaretherearecordsoflist?
原材料发放如何保证先进先出原则,是否有帐台明细表记录?",7.5.5,2,,,
,,,8.3,"Aretherewaysofwarehousemanagementforrawmeterials,WIPandproduct?
是否制定原料、半成品、成品仓库管理办法?",7.5.5,2,,,
,,,8.4,Doesthesuppliermonitortotemperatureandhumidityinthesestorageareasatappropriateintervals?是否定期对贮存场所的温度和湿度等环境条件进行监测?,7.5.5,2,,,
,,,8.5,Arethereproceduretostipulatetheperiodofvalidityofmaterialsandproductsinstock?是否规定各类材料、成品的库存有效期?,7.5.5,2,,,
,,,,,,,Page_of_,Page7of8,
,,Productmarkingandmanagement(产品标识和管理),8.8,"Doesthesupplierstoredtomaterialsaccordingtodifferentsortofmaterial,whichismarked?各类材料是否分类存放,并且明显标记?",7.5.5,2,,,
,,,8.9,"Arerecordsofcontrolofmaterialsstoredproperly?
材料控制记录是否适当的保存?",7.5.5,2,,,
,,TransportationAssurance(运输保证),9.1,Doesthesupplierconstitutedproceduretocontrolprocessesofdeliverytopreventdamageordeterioration?是否制定运输保证文件以提供运输过程中的产品防护?,8.48.54.2.3,2,,,
9,"AnalysieofDateandContinualimprovement
(数据分析和持续改善)","AnalyseofData
(数据分析)",9.1,"Arethereformalprocedurestoanalysedefectiveproductofreturnfrommarketincludingcorrectionandprevention,continuousmeliorationtoreturndefectiveproductformmarket?对市场返回的不良品是否有一套分析、纠正预防及持续改善流程?",8.48.54.2.3,2,,,
,,,9.2,"Arethereproceduresfortheseparationandmarkingandrecordsandanalysisandmeansofcorrectionandpreventionactiontocontrol?
是否有一套对不合格品进行隔离、标识、记录、分析、改善及采取纠正预防措施的控制方法?",8.38.48.54.2.3,2,,,
,,,9.3,Couldthecorrectiveactionsbeefficaciouslyeliminatedthefailures?纠正措施是否可以有效地消除不合格?,8.5.2,2,,,
,,,9.4,Arepreventiveactionsmonitoredforvaliditytopreventingsimilarnonconformance?是否对预防措施的有效性进行监控确认?,8.5.38.2.3,2,,,
,,"Continualimprovement
(持续改善)",9.6,"Areanyobjectivespresentedcontinualandamendatorytrend,whichitiscollectedandanalysetostatusofobjectivestoidentifychanceofcontinualimprovement?设定的各项目标是否呈持续改善趋势,并针对目标定期统计达成状况,并从中识别持续改善的机会?",8.47.1,2,,,
,,,9.8,"HasthesuppliertermlysurveyedthedegreeoftheCustomersatisfaction?
是否定期进行顾客满意度调查?",8.4,2,,,
10,SupportforQualityCooperate(质量合作支持能力),"DisposeFlowforComplaintofCustomer
(客户投诉处理流程)",10.1,"Isthereadetailedprocedureforflowofcomplaintofcustomer?
对于客户投诉是否有具体的处理流程?",8.3,2,,,
,,,10.2,Howdidthesupplierprescribedandensuredefficiencyofresponseonthecustomercomplaintinprocedure?如何规定和保证客户投诉响应速度?,8.2.1,2,,,
,,"RelevantdataforQualityAssurance
(质量保证资料提供情况)",10.3,Couldthesupplierprovideessentialdataofqualityassuranceinordertobedemonstrate?是否能提供必要的证明质量保证的资料?,/,2,,,
,,,10.4,Couldthesupplierprovidestatusbetweenqualitylevelandqualityobjectivesforcurrentproduct?是否能提供当前产品达到的质量水平和质量目标比较情况?,/,2,,,
,,,10.5,Couldthesupplierproviderelevantdatatomeettocustomerrequirementsintimes?是否能按照客户要求的时间提供相关资料?,/,2,,,
,,,10.6,Arethesupplierdefinedforthewindowsofqualityandmanagementrepresentative?质量接口人和管理者代表联络窗口是否明确?,/,2,,,
,,,10.7,"Hasthesupplierhadainformtothecustomerwhenfoundbugandmajordefectofproductinprodutionprocesses?Isthereaprocedureforthisflow?
在生产过程中发现产品缺陷或者重大不合格后是否通知客户,是否有文件规定?",/,2,,,
,,,10.8,"Hasthesupplierdonetheexperimentationandaccessorialinspectfortherequirementsofcustomerinprocessofproduction?
产品持续生产过程中是否按照客户要求进行例行试验、增加确认检验?",/,2,,,
,,,,,,,
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