ISO9001中英文质量手册

质量手册QUALITYMANUAL文件编号:QM-01DocumentNo.:QM-01版本:02Version:02页次:PAGE1ofNUMPAGES45Page:PAGE1ofNUMPAGES45质量管理体系文件QualityManagementSystemDocument制定Preparedby审核:Checkedby:批准:Approvedby:日期Date日期Date日期DateDistributionlist分发签收清单客服部CSDept日期Date开发部D&DDept日期Date物料部MaterialDept日期Date品质部QADept日期Date生产部Prod.Dept日期Date货仓部WH.Dept日期Date运作部OPDept.日期Date采购开发部SourcingDept日期Date工程部EngineeringDept日期Date人事&行政部HR&Admin.Dept日期DateRevisionHistory修订记录REVISION版本DESCRIPTIONOFCHANGE修订内容ORIGINATOR起草人RELEASEDATE发行日期目录Content前言Prelude序言…………………6Foreword公司简介……………6Companyprofile质量方针……………7Qualitypolicy范围Scope产品范围…………….7Productscope场所范围…………….7Sitescope删节说明…………….7Cancellation引用标准………………….7Normativereference术语和定义……………….7-8Terms质量管理体系Qualitymanagementsystem总要求……………….8-9Generalrequirements文件要求…………….9-11Documentationrequirements管理职责Managementresponsibility管理承诺…………….11Managementcommitment以顾客为中心……………………….11Customerfocus质量方针…………….12Qualitypolicy策划………………….12Planning职责、权限和沟通………………….12-13Responsibility,authorityandcommunication管理评审…………….13-14Managementreview6.资源管理Resourcemanagement资源提供…………….14-15Provisionofresources人力资源…………….15Humanresources基础设施…………….15-16Infrastructure工作环境…………….16Workenvironment7.产品实现Productrealization产品实现的策划…………………….16Planningofproductrealization与顾客有关的过程………………….16-18Customer-relatedprocesses设计和开发………….18-20Designanddevelopment采购………………….20-21Purchasing生产………………….21-23Production监视和测量装置的控制…………….23-24Controlofmonitoringandmeasuringdevices8.测量、分析和改进Measurement,analysisandimprovement总则………………….24General监视和测量………….24-26Monitoringandmeasurement不合格品的控制…………………….26Controlofnonconformingproduct数据分析……………..26-27Analysisofdata改进………………….27-28Improvement9.附件Attachments附件1:质量管理体系流程图……………………..29-30Attachment1:QMSFlowchart附件2:组织架构图………………..31Attachment2:OrganizationalStructure附件3:部门职责对照表…………..………………32-34Attachment3:DepartmentalResponsibilityDeployment附件4:质量手册和程序清单……………………..35-36Attachment4:QMSManualandProcedureList附件5:部门职责一览表…………37-41Attachment5:Departmentalresponsibility附件6:质量目标分解表…………42Attachment6:QualityObjectives附件7:QMS管理者代表任命书………………...43Attachment7:AppointmentofQMSManagementRepresentative附件8:培训表格…………………...44Attachment8:TrainingForm前言Prelude序言Foreword企业要发展壮大,就必须有先进的管理方法.在结合本厂产品、实际情况、《ISO9001:2008质量管理体系要求》标准的前提下,制定了本《质量手册》.Businessexpansionalwaysdependsonadvancedmanagerialmethods.Hereby,wehaveformulatedthisQualityManualconsideringthecharacteristicsofourproducts,managerialstatusandISO9001:2008.本手册规定了公司质量方针、质量目标及建立、实施和改进质量管理体系的基本要求.ThisManualhasdefinedqualitypolicy,qualityobjectives,andthebasicrequirementsforestablishing,implementingandimprovingqualitymanagementsystem全体员工必须依据本手册及其支持性文件——程序文件、操作指导书、技术规范、国家法律、法规的规定进行运作，创造一种持续满足顾客要求的机制。PersonnelinXXXXXshallgobythismanualanditssupportivedocuments,cedures,workinstructions,specifications,andlegalrequirementstocreateamechanismsatisfyingcustomerrequirementscontinually公司简介Companyprofile公司名字:

:xxxxx)/Companyname

:XXXXXLtd(Include)企业性质

:港资Capitalorigin:HKinvestment成立时间:xxxxx成立于Foundedin:地址Address:主要产品Mainproducts:手袋及其它缝纫制品。Bagsandothersewingproducts.主要生产流程Mainproductionprocesses:开料→贴合/热压/电压/烫画→车缝→包装Cutting→Lamination/Thermoforming/Highfrequency/Transfersticker→Sewing→Packing主要生产设备Mainproductionequipment:裁床、贴合机、热压机、电压机、针车等.Cuttingmachine,laminationmachine,thermoformingmachine,highfrequencymachine,sewingmachine,etc.主要测试仪器Mainmeasuringdevices:盐雾试验机、破裂强度测试仪、卡尺、硬度计、千分尺、拉力计、推拉力计、电子天平、验布机及及其它布料测试设备等.Saltspraytestmachine,brokenstrengthtester,caliper,hardnesstester,microscope,pullgage,push-pullgage,electronicweightscale,fabricinspectionmachineandotherfabrictestingequipment.质量方针Qualitypolicy:持续过程优化,追求顾客满意.Continualimprovementandcustomersatisfaction.范围Scope产品范围Productscope手袋及其它缝纫制品。Bagsandothersewingproducts.场所范围Locationscope删节说明Cancellation本手册“第7.3条设计和开发”只适用于xxxxx,不适用于xx.Theelements“7.3designanddevelopment”isonlyapplicableforxxxLbutnotapplicableforxx.因为xx依据xxxxx的样板、技术图纸进行制作样板,在样板得到xxxxx的承认之后进行产品生产,故本要素不适用于xxxxx.Thecauseofnotapplicable:becausexxcarriesoutsamplemakingbasedonbenchmarkingsamplesorspecificationprovidedbyxx,andxxcommencemassproductiononlyaftersamplehasbeenapprovedbyxxx引用标准Normativereference《ISO9000:2005质量管理体系—基础和术语》ISO9000:2005QualityManagementSystemFundamentalsandvocabulary《ISO9001:2008质量管理体系要求》ISO9001:2008QualityManagementSystemRequirements术语和定义Terms质量Quality一组固有特性满足要求的程度.Degreetowhichasetofinherentcharacteristicsfulfillsrequirements注1:术语“质量”可使用形容词如差、好或优秀来修饰Note1:theterm“quality”canbeusedwithadjectivessuchaspoor,goodorexcellent注2:“固有的”(其反义是“赋予的”)就是指在某事或某物中本来就有的,尤其是那种永久的特性Note2:“Inherent”,asopposedto“assigned”,meansexistinginsomething,especiallyasapermanentcharacteristics顾客满意Customersatisfaction顾客对其要求已被满足的程度的感受Customer’sperceptionofthedegreetowhichthecustomer’srequirementshavebeenfulfilled注1:顾客投诉是一种满意程度低的最常见的表达方式,但没有投诉并不一定表明顾客很满意Note1:customercomplaintareacommonindicatoroflowcustomersatisfactionbuttheirabsencedosenotnecessarilyimplyhighcustomersatisfaction注2:即使规定的顾客要求符合顾客的愿望并得到满足,也不一定确保顾客很满意Note2:evenwhencustomer’srequirementshavebeenagreedwiththecustomerandfulfilled,thisdoesnotnecessarilyensurehighcustomersatisfaction顾客Customer接受产品的组织或个人Organizationorpersonthatreceivesaproduct供应商/供方Supplier提供产品的组织或个人Organizationorpersonthatprovidesaproduct过程Process一组将输入转化为输出的相互关联或相互作用的活动Setofinterrelatingorinteractingactivitieswhichtransformsinputsintooutputs产品Product过程的结果Resultofaprocess合格Conformity满足要求Fulfillmentofarequirement不合格Nonconformity未满足要求Non-fulfillmentofarequirement预防措施Preventiveaction为消除潜在不合格或其他潜在不期望情况的原因所采取的措施Actiontoeliminatethecauseofapotentialnonconformityorotherpotentialundesirablesituation纠正Correction为消除已发现的不合格所采取的措施Actiontoeliminatedetectednonconformity纠正措施Correctiveaction为消除已发现的不合格或其他不期望情况的原因所采取的措施Actiontoeliminatethecauseofadetectednonconformityorotherundesirablesituation文件Document信息及其承载媒体Informationanditssupportingmedium记录Record阐明所取得的结果或提供所完成活动的证据的文件Documentstatingresultsachievedorprovidingevidenceofactivitiesperformed质量管理体系Qualitymanagementsystem总要求Generalrequirements本公司将按照本《质量手册》的要求建立质量管理体系,形成文件,加以实施和保持,并持续改进其有效性.Ourcompanyshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisQualityManual本公司将:Ourcompanyshall识别质量管理体系所需的过程及其在公司内的应用;Identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughoutourcompany确定这些过程的顺序和相互作用(见附件1:质量管理体系流程图);Determinethesequenceandinteractionoftheseprocesses(seeattachment1:QMSFlowchart)确保为这些过程的有效运作和控制所需的准则和方法;Determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective确保可以获得必要的资源和信息,以支持这些过程的运作和监视;Ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationoftheseprocesses监视、测量和分析这些过程;Monitor,measureandanalyzetheseprocesses,and实施必要的措施,以实现对这些过程所策划的结果和对这些过程的持续改进Implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses本公司必须按照《ISO9001:2008质量管理体系要求》管理上述的过程;TheseprocessesshallbemanagedbyourcompanyinaccordancewithISO9001:2008QualityManagementSystem针对本公司所外包的任何影响产品符合性的过程,本公司将确保对其予以识别和控制.Wherewechoosetooutsourceanyprocessthataffectsproductconformitywithrequirements,weshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.本公司的外包活动:部分工序,按照本公司《生产管理程序》进行控制.Someprocesseswillbeoutsourcedsometimes,andshallbeincontrolaccordingtoProductionManagementProcedure.文件要求Documentationrequirements总则General质量体系文件包括:Documentationofthequalitymanagementsystemconsistsof质量方针和质量目标;Qualitypolicyandqualityobjectives质量手册;QualityManual《ISO9001:2008质量管理体系要求》所要求的程序文件和本公司确定的其它程序文件,见附件4:《质量手册和程序清单》;DocumentedproceduresrequiredbyISO9001:2008QualityManagementSystemandourcompany,seeattachment4:本公司为确保过程有效策划、运作和控制所需的文件;Documentsneededbyourcompanytoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andQMSManualandProcedureList《ISO9001:2008质量管理体系要求》所要求的记录(见本手册第4.2.4条)RecordsrequiredbyISO9001:2008QualityManagementSystem(see4.2.4文件的形式:纸质或电子文件.Mediaofdocuments:paperorelectroniccarrier质量手册QualityManual本公司编制和保持本《质量手册》,且包括:WeshallestablishandmaintainthisQualityManualthatincludes质量管理体系的范围,包括任何删节的细节和合理性,见本手册第1章节:“范围”;Thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusion(seechapter1:Scope)为质量管理体系编制的形成文件的程序或对其引用;Thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and质量管理体系过程的相互作用的表述.Adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem本《质量手册》由管理者代表编制、总经理审核;ThisQualityManualshallbedraftedbyManagementRepresentative,andshallbeapprovedbyGeneralManager本《质量手册》按照《文控程序》进行控制.ThisQualityManualshallbecontrolledbasedonDocumentControlProcedure文件控制Controlofdocument质量管理体系所要求的文件必须予以控制.质量记录是一种特殊类型的文件,应按照第4.2.4条款的要求进行控制;Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4建立《文控程序》,以规定以下方面所需的控制:DocumentControlProcedureshallbeestablishedtodefinethecontrolsneeded文件发布前得到批准,以确保文件是充分与适宜的;toapprovedocumentsforadequacypriortoissue必要时,对文件进行评审与更新,并再次批准;toreviewandupdateasnecessaryandre-approvedocuments确保文件的更改和现行修订状态得到识别;toensurethatchangesandthecurrentversionstatusofdocumentsareidentified确保在使用处可获得有关版本的适用文件;toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse确保文件保持清晰、易于识别;toensurethatdocumentsremainlegibleandreadilyidentifiable确保外来文件得到识别,并控制其分发;toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and防止作废文件的非预期使用,若因任何原因而保留作废文件时,对这些文件进行适当的标识.topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose质量记录的控制Controlofqualityrecords建立《记录管理程序》,以便:RecordControlProcedureshallbeestablishedto建立并保持质量记录,以提供符合要求和质量管理体系有效运行的证据;establishandmaintainqualityrecordsinordertoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem确保质量记录保持清晰、易于识别和检索;ensurerecordscanremainlegible,readilyidentifiableandretrievable规定质量记录的标识、贮存、检索、保存期限和处置所需的控制.todefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords管理职责Managementresponsibility管理承诺Managementcommitment总经理将通过以下活动,对建立、实施质量管理体系并持续改进有效性的承诺提供证据:GeneralManagershallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby向公司全体成员传达满足顾客和法律法规要求的重要性;communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,制定质量方针;establishingthequalitypolicy制定质量目标,并定期进行统计和检讨;ensuringthatqualityobjectivesareestablished进行管理评审;conductingmanagementreviews,and提供适当的资源;ensuringtheavailabilityofresources以顾客为中心Customerfocus总经理以增强顾客满意为目的,确保顾客的要求得到确定并予以满足;GeneralManagershallensurethatcustomerrequirementsaredeterminedandmetwiththeaimofenhancingcustomersatisfaction建立和实施《客户服务程序》,包括对顾客订单进行有效评审及顾客满意度的调查.CustomerServiceProcedureshallbeestablishedandimplemented,includingthecustomerOrderReviewandCustomerSatisfactionSurvey.质量方针Qualitypolicy总经理应确保质量方针:GeneralManagershallensurethatthequalitypolicy与公司的宗旨想适应;isappropriatetothepurposeofourcompany包括对满足要求和持续改进质量管理体系有效性的承诺;includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem提供制定和评审质量目标的框架;providesaframeworkforestablishingandreviewingqualityobjectives在组织内得到沟通和理解;iscommunicatedandunderstoodwithintheorganization,and在持续适宜性方面得到评审.Isreviewedforcontinuingsuitability本公司的质量方针,见“前言”章节.Aboutqualitypolicyofourcompany,seetheForewordtothisManual策划Planning质量目标Qualityobjectives总经理应确保在公司的相关职能和层次上建立质量目标,质量目标包括满足产品要求所需的内容;GeneralManagershallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct,areestablishedatrelevantfunctionsandlevelswithintheorganization质量目标应是可测量的,并与质量方针保持一致;Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy本公司的质量目标见附件6:《质量目标分解表》Aboutthequalityobjectivesofourcompany,seeattachment6,QualityObjectives质量管理体系策划Qualitymanagementsystemplanning总经理应确保:GeneralManagershallensurethat对质量管理体系进行策划,以满足质量目标和本手册第4.1条款的要求;theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1ofthisManual,aswellasthequalityobjectives,and在对质量管理体系的更改进行策划和实施时,保持质量管理体系的完整性.theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented职责、权限和沟通Responsibility,authorityandcommunication职责和权限Responsibilityandauthority总经理应确保组织的职责、权限及其相互关系的得到规定和沟通;GeneralManagershallensuretheresponsibilitiesandauthoritiesaredefinedandcommunicatedwithinourcompany各部门的职责与权限,见附件2:《组织架构图》;附件3:《部门职责对照表》;附件5:《部门职责一览表》Aboutdepartmentalresponsibilitiesandauthorities,seeattachment2:OrganizationalStructure;andattachment3:DepartmentalResponsibilityDeployment管理者代表ManagementRepresentative总经理应任命管理者代表(见附件7:《管理者代表任命书》),以便履行下述职责与权限:GeneralManagershallappointamemberofmanagementwho(seeattachment7:AppointmentofQMSManagementRepresentative),irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatinclude确保质量管理体系所需的过程得到建立、实施和保持;ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained向总经理报告质量管理体系的业绩和任何改进的需求;reportingtoGeneralManagerontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and确保在公司内提高满足顾客和法律法规要求的意识;ensuringthepromotionofawarenessofcustomerrequirementsthroughoutourcompany,and与质量管理体系有关事宜的外部联络,如:认证机构、咨询机构,等.liaisingwithexternalpartiesonmattersrelatingtothequalitymanagementsystem内部沟通Internalcommunication总经理应该确保在组织内建立适当的沟通过程,并确保对质量管理体系的有效性进行沟通;GeneralManagershallensurethatappropriatecommunicationprocessesareestablishedwithinourcompanyandthatcommunicationtakesplacesregardingtheeffectivenessofthequalitymanagementsystem本公司的沟通途径:电子邮件、信件、会议,等Communicationchannelsinourcompanyincludeemail,letter,meeting,etc管理评审Managementreview总则General总经理应确保建立、实施和改进《管理评审程序》,以便GeneralManagershallestablish,implementandimproveManagementReviewProcedureto最少一年一次评审公司的质量管理体系,以确保其持续的适宜性、充分性和有效性;reviewthequalitymanagementsystemofourcompanyatleastyearlytoensureitscontinuingsuitability,adequacyandeffectiveness,and评审应包括评价质量管理体系改进的机会和变更的需要,包括质量方针和质量目标;assessopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives保留管理评审记录Recordsfrommanagementreviewshallbemaintained评审输入Reviewinput管理评审的输入必须包括以下方面的信息:Theinputtomanagementreviewshallincludeinformationon质量方针的适宜性;suitabilityofthequalitypolicy质量目标的适宜性;suitabilityofqualityobjectives外/内部审核的结果;resultsofbothinternalandexternalaudits顾客反馈;customerfeedback过程的业绩和产品的符合性;processperformanceandproductconformity预防和纠正措施的状况;statusofpreventiveandcorrectiveactions以往管理评审的跟踪措施;follow-upactionsfrompreviousmanagementreviews经策划的可能影响质量管理体系的变更;changesthatcouldaffectthequalitymanagementsystem,and改进的建议recommendationsforimprovement评审输出Reviewoutput管理评审的输出应该包括与以下方面有关的任何决定和措施:Theoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto质量管理体系及其过程有效性的改进;Improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses与顾客有关的产品的改进;improvementofproductrelatedtocustomerrequirements,and资源的需求.resourceneeds资源管理Resourcemanagement资源提供Provisionofresources总经理应确定并提供所需要的资源,以:GeneralManagershalldetermineandprovidetheresourcesneeded实施、保持质量管理体系并持续改进其有效性;toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,and通过满足顾客要求,增强顾客满意.toenhancecustomersatisfactionbymeetingcustomerrequirements人力资源Humanresources总则General基于适当的教育、培训、技能和经验,从事影响产品质量工作的人员应是能够胜任的.Personnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience能力、意识和培训Competence,awarenessandtraining建立、实施和改进《培训程序》,以:TrainingProcedureshallbeestablished,implementedandimprovedto确定从事影响产品质量工作的人员所必要的能力;determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality提供培训或采取其它措施以满足这些需求;providetrainingortakeotheractionstosatisfytheseneeds评价所采取措施的有效性;evaluatetheeffectivenessoftheactionstaken确保员工意识到所从事活动的相关性和重要性,和如何为实现质量目标作出贡献;ensurethatthepersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,and保持教育、培训、技能和经验的适当记录.maintainappropriaterecordsofeducation,training,skillsandexperience基础设施Infrastructure公司应确定、提供并维护为达到产品要求的符合性所需的基础设施,如:Ourcompanyshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicable建筑物、工作场所和相关设施;buildings,workspaceandassociatedutilities过程设备,包括硬件和软件;Processequipment(bothhardwareandsoftware),and支持性服务,如运输或通讯supportingservices(suchastransportorcommunication)建立、实施和改进《生产设备管理程序》,以对生产设备进行正确的操作、保养和维修;ProductionEquipmentManagementProcedureshallbeestablished,implementedandimprovedtoproperlyoperate,maintainandrepairproductionequipment建立、实施和改进《监控与测量设备控制程序》,以对测量和监视装置进行正确的操作、保养和校正;MonitoringandMeasuringDeviceManagementProcedureshallbeestablished,implementedandimprovedtoproperlyoperate,maintainandcalibratemeasuringandmonitoringdevices建立、实施和改进《模具管理程序》,以对模具装进行验证和保养.MoldManagementProcedureshallbeestablished,implementedandimprovedtoverifyandmaintainmolds.工作环境Workenvironment公司应确定和管理为实现产品要求符合性所需的工作环境。Ourcompanyshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements，产品实现Productrealization产品实现的策划Planningofproductrealization本公司将策划和开发产品实现所需的过程.产品实现的策划应与质量管理体系其他过程的要求相一致.Ourcompanyshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesofthequalitymanagementsystem在对产品实现进行策划时,应确定以下方面的适当内容:Inplanningproductrealization,weshalldeterminethefollowing,asappropriate产品的质量目标和要求;qualityobjectivesandrequirementsfortheproduct针对产品确定过程、文件和资源的需求;theneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproduct产品所需求的验证、确认、监视、检验和试验活动,和产品接收准则;requiredverification,validation,monitoring,inspectionandtestactivitiesspecifiedtotheproductandthecriteriaforproductacceptance为实现过程及其产品满足要求提供证据所需的记录.recordsneededtoprovideevidencethattherealizationprocessesandresultingproductmeetrequirements策划的输出形式应适于本公司的运作方式.Theoutputofthisplanningshallbeinaformsuitableforourcompany’smethodofoperations注1:对应用于特定产品、项目或合同的质量管理体系的过程(包括产品实现过程)和资源作出规定的文件可称之为质量计划;Note1:Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingtheproductrealizationprocesses)andtheresourcestobeappliedtoaspecificproduct,projectorcontract,canbereferredtoasaqualityplan注2:也可以将条款7.3的要求应用于产品实现过程的开发.Note2:Theorganizationmayalsoapplytherequirementsgivenin7.3tothedevelopmentofproductrealizationprocesses与顾客有关的过程Customer-relatedprocesses与产品有关的要求的确定Determinationofrequirementsrelatedtotheproduct公司必须确定:Ourcompanyshalldetermine顾客规定的要求,包括对交付及交付后活动的要求;requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost-deliveryactivities顾客虽然没有明示,但规定的用途或已知和预期用途所必需的要求;requirementsnotstatedbythecustomerbutnecessaryforspecifiedorintendeduse,whereknown与产品有关的法律法规要求;statutoryandregulatoryrequirementsrelatedtotheproduct,and本公司确定的任何附加要求.anyadditionalrequirementsdeterminedbyourcompany与产品有关的要求的评审Reviewofrequirementsrelatedtotheproduct公司建立、实施和改进《客户服务程序》,以评审与产品有关的要求;CustomerServiceProcedureshallbeestablished,carriedoutandimprovedtoreviewtherequirementsrelatedtotheproduct评审在向顾客作出提供产品的承诺之前进行(如:提交标书、接受合同或订单、接受合同或订单的更改),并确保:thisreviewshallbeconductedpriortoourcommitmenttosupplyaproducttothecustomer(e.g.submissionoftenders,acceptanceofcontractsororders,acceptanceofchangestocontractsororders)andshallensurethat产品要求得到规定;productrequirementsaredefined与以前表述不一致的合同或订单的要求已予以解决;contractororderrequirementsdifferingfromthosepreviouslyexpressedareresolved,and有能力满足规定的要求.wehavetheabilitytomeetthedefinedrequirements评审结果及评审所引发的措施的记录必须予以保持;Recordsoftheresultsofthereviewandactionsarisingfromthereviewshallbemaintained若顾客提供的要求没有形成文件,业务人员在接收顾客要求前应要求顾客提供书面文件,本公司不接受口头指示;Wherethecustomerprovidesnodocumentedstatementofrequirement,thesalespersonnelshallrequestthecustomertoprovidethedocument.XXXXXdoesnotacceptanyverbalinstructions.若产品要求发生变更,应确保相关文件得到修改,并确保相关人员知道已变更的要求.Whereproductrequirementsarechanged,weshallensurethatrelevantdocumentsareamendedandthatrelevantpersonnelaremadeawareofthechangedrequirements顾客沟通Customercommunication本公司将对以下有关方面确定并实施与顾客沟通的有效安排:Ourcompanyshalldetermineandimplementeffectivearrangementforcommunicatingwithcustomersinrelationto产品信息;productinformation问询、合同或订单的处理,包括对其的修改;enquiries,contractsororderhandling,includingamendments,and顾客反馈,包括顾客投诉.customerfeedback,includingcustomercomplaints设计和开发Designanddevelopment本公司建立、实施和改进《新产品设计与开发程序》以确保产品的固有品质、效力、安全性及顾客满意度.NewProductDesignandDevelopmentProcedureshallbeestablished,carriedoutandimprovedtoensuretheinherentquality,effectiveness,safetyandcustomersatisfactionoftheproduct.设计和开发策划DesignandDevelopmentPlanning在设计和开发策划期间,本公司需确定Duringthedesignanddevelopmentplanning,ourcompanyshalldetermine:设计各开发所需的过程和阶段;thedesignanddevelopmentstages在设计和开发的各阶段进行适当的评审,验证和确认;thereview,verificationandvalidationthatareappropriatetoeachdesignanddevelopmentstage,and设计和开发的职责与权限;theresponsibilitiesandauthoritiesfordesignanddevelopment.公司需处理好参与设计与开发的不同小组间的工作衔接以确保有效交流及明确分工.Thecompanyshallmanagetheinterfacesbetweendifferentgroupsinvolvedindesignanddevelopmenttoensureeffectivecommunicationandclearassignmentofresponsibility.策划的结果应根据设计和开发的进展进行适当的更新.Planningoutputshallbeupdated,asappropriate,asthedesignanddevelopmentprogresses.设计和开发输入Designanddevelopmentinputs需确定与产品要求相关的设计和开发输入并保存相关记录,输入包括:Inputsrelatingtoproductrequirementsshallbedeterminedandrecordsmaintained,Theseshallinclude功能、性能和外观要求;Functional,performanceandappearancerequirements,适用的法律及法规要求;applicablestatutoryandregulatoryrequirements,以前类似的设计信息;whereapplicable,informationderivedfromprevioussimilardesigns,and设计和开发的其它重要要求.otherrequirementsessentialfordesignanddevelopment.设计和开发输入的适当性需进行评估.要求需完整,明确且不相互抵触.Theseinputsshallbereviewedforadequacy.Requirementsshallbecomplete,unambiguousandnotinconflictwitheachother.设计和开发输出Designanddevelopmentoutputs设计和开发输出必须以表格的形式提供以便能对应设计和开发输入进行验证,此外在分发前必须获得批准.Theoutputsofdesignanddevelopmentshallbeprovidedinaformthatenablesverificationagainstthedesignanddevelopmentinputandshallbeapprovedpriortorelease.设计和开发输出须Designanddevelopmentoutputsshall满足设计和开发输入的要求;meettheinputrequirementsfordesignanddevelopment,提供正确的采购生产及服务信息;provideappropriateinformationforpurchasing,productionandforserviceprovision,包含或提及产品接受标准;containorreferenceproductacceptancecriteria,and详述产品基本的安全及正确使用方面的特性.specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.设计和开发评审Designanddevelopmentreview在适当时期,应根据策划阶段已拟定的计划对设计与开发进行系统的评审.Atsuitablestages,systematicreviewsofdesignanddevelopmentshallbeperformedinaccordancewithplannedarrangements.评估设计和开发结果满足要求的能力Toevaluatetheabilityoftheresultsofdesignanddevelopmenttomeetrequirements,and识别所有问题并提出必要措施toidentifyanyproblemsandproposenecessaryactions.评审过程的参与者应包括与被评审的设计和开发阶段相关的各部门代表,应保存相关的评审结果及必要措施的记录.Participantsinsuchreviewsshallincluderepresentativesoffunctionsconcernedwiththedesignanddevelopmentstage(s)beingreviewed.Recordsoftheresultofthereviewsandanynecessaryactionsshallbemaintained.设计和开发验证Designanddevelopmentverification应根据策划阶段已拟定的计划对设计和开发进行验证以确保其输出满足输入的要求,应保存设计和开发验证的结果及必要措施的记录,以下一种或多种验证方法均可接受:Verificationshallbeperformedinaccordancewithplannedarrangementstoensurethat