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Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:1/27有限公司:质量环境手册Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:2/27有限公司:RevisionHistory版本修改履历Rev.版本012013-12-27Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:3/27有限公司:PAGE页码1.0INTRODUCTIONTOCMSPRECISIONMECHANICALMAMUFACTURING(WUJIANG)CO.,LTD6希迈斯精密机械制造(吴江)有限公司介绍66质量环境管理体系范围62.0NORMATIVEREFERENCE6引用标准63.0TERMSANDDEFINITIONS6术语和定义64.0QUALITY&ENVIRONMENTALMANAGEMENTSYSTEM7质量和环境管理体系74.1D7文件要求74.1.1S&ES7质量和环境体系结构74.1.2DOCUMENTS7文件管控74.1.3C8记录管控85.0MANAGEMENTRESPONSIBILITY8管理职责85.1MANAGEMENTCOMMITMENT8管理承诺85.2CUSTOMERFOCUS8以客户为关注焦点85.3QUALITY&ENVIRONMENTALPOLICY9质量和环境方针95.3.1QUALITYPOLICY9质量方针95.3.2ENVIRONMENTALPOLICY9环境方针95.4PLANNING9策划95.4.1QUALITYANDENVIRONMENTALOBJECTIVES9质量和环境目标95.4.2QUALITYANDENVIRONMENTALMANAGEMENTSYSTEMPLANNING9质量和环境管理体系策划95.5RESPONSIBILITY,ROLES,RESOURCES,AUTHORITYANDCOMMUNICATION9职责、资源、作用、权限和沟通95.5.1ORGANIZATIONSTRUCTURE9组织架构95.5.2INTERNALCOMMUNICATION11内部沟通115.5.3ENVIRONMENTALCOMMUNICATION11环境沟通115.6MANAGEMENTREVIEW11管理评审115.7ENVIRONMENTALASPECTS12环境因素125.8LEGALANDOTHERREQUIREMENTS12法律法规及其它要求126.0RESOURCEMANAGEMENT13资源管理136.1PROVISIONOFRESOURCES13资源的提供136.2HUMANRESOURCES13人力资源136.2.1COMPETENCE,AWARENESSANDTRAINING13能力,意识和培训136.3INFRASTRUCTURE13基础设施136.3.1EMERGENCYPREPAREDNESS&RESPONSE13Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:4/27有限公司:应急准备与响应136.4WORKENVIRONMENT13工作环境137.0PRODUCTREALIZATION13产品的实现137.1PLANNINGOFPRODUCTREALIZATION13产品实现的策划137.2CUSTOMER-RELATEDPROCESSES14与顾客有关的过程147.2.1DETERMINATIONOFREQUIREMENTSRELATEDTOTHEPRODUCT14与产品有关的要求的确定147.2.2REVIEWOFREQUIREMENTSRELATEDTOTHEPRODUCT14与产品要求有关的评审147.2.3CUSTOMERCOMMUNICATION14与顾客的沟通147.3DESIGNANDDEVELOPMENT14设计和开发147.4PURCHASING14采购147.4.1PURCHASINGPROCESS14采购的过程147.4.2PURCHASINGINFORMATION14采购信息147.4.3VERIFICATIONOFPURCHASEDPRODUCT14采购产品的验证147.5PRODUCTIONANDSERVICEPROVISION15生产和服务提供157.5.1CONTROLOFPRODUCTIONANDSERVICEPROVISION15生产和服务提供的控制157.5.2VALIDATIONOFPROCESSESFORPRODUCTIONANDSERVICEPROVISION15生产和服务提供的过程确认157.5.3PRODUCTIDENTIFICATIONANDTRACEABILITY15产品的标识与追溯157.5.4CUSTOMERPROPERTY16顾客财产167.5.5PRESERVATIONOFPRODUCT16产品的防护167.6CONTROLOFMONITORINGANDMEASURINGEQUIPMENT16监视和测量设备的控制168.0MEASUREMENT,ANALYSISANDIMPROVEMENT16测量、分析和改进168.1MONITORINGANDMEASUREMENT16监视和测量168.2.1CUSTOMERSATISFACTION17顾客满意178.2.2INTERNALAUDIT17内部审核178.2.3MONITORINGANDMEASUREMENTOFPROCESSES17过程的监视和测量178.2.4MONITORINGANDMEASUREMENTOFPRODUCT17产品的监视和测量178.3CONTROLOFNONCONFORMINGPRODUCT17不合格品的控制178.4ATA18数据分析188.5I18改进1818持续改进188.5.2C18纠正措施188.5.3P18预防措施18Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:5/27有限公司:Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:6/27有限公司:CMSPrecisionMechanicalManufacturing(Wujiang)Co.,LtdstartedbusinessformallyinJun.2012asawhollyownedsubsidiaryofCMSGroupinItaly.CMSGroupismajorengagedinthebusinessofdeveloping,manufacturingandsellingcomponents,modulesandcompletesystemsforthefoodprocessingandpackaging,forthemechanicalfield,railwaysfieldandindustrialplantsfield,andhasmanyyears’experience,technologyandknow-howinsuchfields.希迈斯精密机械制造(吴江)有限公司,于2012年6月开始正式营业,隶属于意大利希迈斯集团,集团主要从事食品加工及包装领域、机械领域、铁路及工业领域使用的设备组件、模具和整套系统的研发、生产和销售。CMSPrecisionMechanical(Wujiang)Co.,LTDislocatedinthesouthofQuandeRoadandthewestofPangjinRoad,WujiangEconomic&TechnologicalDevelopmentZone,JiangsuProvince.CMSisbuiltonafactoryareaof14000squaremeters.希迈斯精密机械制造(吴江)有限公司位于江苏省吴江经济技术开发区泉德路以南,庞金路以西。工厂占地14000平方米。Vision愿景:AddressingtheChinamarketasaglobalpartnerofleadingcompaniesintheirsector,fordesign,development,manufacturing,testingandsupplyofmachinesandcomponentsinvolvinghighlevelsofcomplexityandprecision致力于成为中国市场行业领先企业的全球合作伙伴,设计、开发、制造、测试和提供高水平、复杂性和高精度的机器和机器零部件。Manufacturingofmachinesandequipmentforpacking,filling,partshandling&transportation,railwayequipment,wastedisposal,environmentcare,industrial/factoryautomationsandtherelevantcomponentsandparts,salesofself-manufacturedproducts;import,exportandwholesaleofproductsofthesamecategoryastheself-manufacturedproducts;provisionofmaintenanceservices,after-salesservices,relevanttechnicalconsultationandinformationconsultation.从事包装设备,灌装设备,搬运传送设备,铁路设备,废物处理和环保设备及相关零部件的生产,销售所涉及到的相关活动,从事与本公司生产产品同类商品的批发及进出口业务,并提供维修服务,售后服务和相关技术咨询和信息咨询。ISO9001:2008Clause7.3–DesignandDevelopmentshallbeexcludedfromCMSQualityManagementSystem,asdesignanddrawingsareprovidedbycustomers.ISO9001:2008条款7.3-设计和开发不适用于此体系,因为设计和图纸都是由客户提供的。Ourcompanyhasoutsourcingprocess:surfacetreatment,outsourcedprocessing,andtheoutsourcesactivitiesarecontrolledandmonitoredbypurchasingprocedures.022.0NORMATIVEREFERENCE引用标准3.0TERMSANDDEFINITIONS术语和定义:S质量管理体系EMS:EnvironmentalManagementSystem环境管理体系Environment:Thesurroundingsinwhichtheorganizationoperates,includingair,water,land,naturalresources,flora,fauna,humans,andtheirinterrelation.组织运行活动的周边环境,包括空气,水,土地,自然资源,植物,动物,人,以及他们之间的相互关系。EnvironmentalAspect:Elementofanorganization’sactivities,productsandservices,whichcaninteractwiththeenvironment.环境因素:一个组织的活动,产品和服务中能与环境发生相互作用的要素EnvironmentalImpact:Anychangetotheenvironment,whetheradverseorbeneficial,whollyorpartiallyresultingfromactivities,productsandservicesoftheorganization.环境影响:全部或部分地由公司的环境因素给环境造成的任何有害或有益的变化。Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:7/27有限公司:Continualimprovement:Recurringprocessofenhancingthesysteminordertoachieveimprovementsinoverallperformance,notnecessarilyinallareasofactivitysimultaneously,butalwaysinlinewithanorganization’spolicy.持续改进:不断对体系进行强化的过程,目的是根据组织的绩效的改进。该过程不必同时发生与活动的所有方面。CMS:CMSP(W)C.,LOThedocumentationoftheQuality&EnvironmentalSystemisdividedtofourbasiclevelsnamelyManual,Procedures,WorkInstructions/StandardOperatingProcedures,andchecklist.质量环境系统文件可以分为4个基本的级别:手册、程序文件、作业指导书,记录表单。ThedocumentsareformulatedinaccordancetoISO9001andISO14001requirementsandconsistentwithCMSqualityandenvironmentalpolicy.文件的形成是依据ISO9001和ISO14001的要求并与希迈斯精密机械制造(吴江)有限公司的质量和环境方针是相符合的。Level1DocumentstatesCMSQuality&EnvironmentalpolicyandgivesanoutlinedescriptionoftheQuality&EnvironmentalSystem.一级文件陈述了希迈斯精密机械制造(吴江)有限公司的质量和环境方针并简要的描述了公司的质量环境体系。Level2Documentsdescribesthecontrolsofprocesses,responsibilities,actionsrequired,method/techniqueused,frequencyandthelocation.二级文件描述了管控过程,职责,行动方法/技巧,频率和位置。Level3Documentsaredetailedinstructionsforperformingaparticularoperationorsimpleinstructionsdisplayedatworkstationforoperator’sreferenceintheformofvisualdisplay.三级文件是详细的作业指导书,或是陈列在工作站点的简单的作业指导,如图片等。CMSQuality&EnvironmentalManagementSystemframeworkshallcomplywiththeISO9001andIS014001StandardrequirementsandcontinuallyimprovestheeffectivenessoftheQuality&EnvironmentalManagementSystem.希迈斯精密机械制造(吴江)有限公司的质量和环境体系架构必须符合ISO9001和ISO14001的标准并能持续改善质量环境管理体系及其有效性。Thereferencematrix(attachment1)definedtherelationofQuality&EnvironmentalManualtoProceduresandISO9001andISO14001clauses.交叉参考图(附件1)是质量环境手册,程序文件,ISO9001及ISO14001条款的相互关系的比对。Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:8/27有限公司:Quality&Environmentalmanual,procedures,workinstructions(SOP)arecontrolledbyQualityDepartmentanddistributedtooperations,whichrequirethem.Alldocumentsarereviewedandapprovedpriortouse.Acontrolleddocumentlist,whichidentifiesthecurrentrevisionstatusismaintainedbyqualitydepartment.质量环境手册,程序文件,作业指导书由质量部管控并分发到需要的部门。所有的文件需要在审核和批准之后才可以发行使用。质量部门必须维护受控文件清单。Changesofcontrolleddocumentsshallbereviewedandapprovedbythesamedepartment,whichoriginatesthedocumentunlessotherwisedesignated.Amendmentsshallbeclearlyidentifiedontheaffecteddocumentsandstatedontherevisionhistory.受控文件的改版除有另外的指定,必须由起草文件的部门审核和批准。修改的部分必须要能清楚的识别,并在改版履历里面说明。Documentsshallbelegibleandreadilyidentifiable.文件必须是清晰并易于识别的。Externaldocuments,exceptfromtechnicalfilesanddrawings,shouldbecontrolledbyQualityDepartmentanddistributedtooperationswhichrequirethem.AlistofproductqualityandEnvironmentalandRegulatoryrequirementsshallbelistedinthecontrolleddocumentlist.外部的文件除产品的图纸和技术文件以外,其他由质量部管控并发行到相关的部门。与产品质量及环境相关的法律法规需要列在文件管控列表中。Controlofrecordshallbeestablishedtoprovideevidenceofconformitytorequirementsoftheeffectiveoperationofthequalitymanagementsystem.控制记录应当成立,以提供符合要求的证据的有效运行质量管理系统。Uponexpiryofretentionperiod,recordshallbedisposedasnormalgarbageorshredifcontainanyconfidentialinformation.当超过保存年限时,记录应当丢弃,若含有机密的信息则予以粉碎销毁。5.1ManagementCommitment管理承诺TopManagementshallcommittothedevelopment,implementationandwellfunctioningoftheQMS(QualityManagementSystem)andEMS(EnvironmentManagementSystem)andcontinuallyimproveitseffectiveness.Inordertoachievethis,topmanagementshallensurethatqualityandenvironmentalpolicyisestablished;最高管理者应致力于质量管理体系和环境管理体系的建立、实施和持续提升其有效性。为达成这样的目标,最高管理层应确保建立质量和环境方针。-Qualityandenvironmentalobjectivesisestablished;建立质量和环境目标。-Theimportanceofmeetingcustomerrequirementsandstatutoryandregulatoryrequirementsarecommunicated;沟通满足顾客要求和法律法规要求的重要性。-Resourcesfortheimplementationandmaintenanceofthequalityandenvironmentmanagementsystemanditsprocessareprovidedinatimelymanner;建立和维护质量和环境管理体系的过程中所需要的资源能够及时获得。-ManagementReviewsareconducted.进行管理评审GeneralManagers,Managers,intheirvariouscapacities,arefullyfocusedtomeetcustomerrequirementsintermsofproductquality,deliveryandcost.TopManagementensuresthatinternalandexternalcommunicationiswelldeveloped.总经理,经理等通过充分发挥各自的工作职能,达到客户对质量、交货期以及价格的要求。最高管理者确保良好的内外部沟通来确保客户的要求可以得到满足。Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:9/27有限公司:ThemanagementofCMShasdevelopedacorporatequalityandenvironmentalpolicywhichmeetstheneedsofCMSanditscustomers.希迈斯的管理层已经建立了公司的质量和环境方针,满足自身和客户需求。CMSisfullycommittedtocustomersatisfaction,providingproductsandservicesofhighstandardsandpursuingcontinuousimprovementinquality,delivery,reliabilityandperformance,withtheaimtoachievethehighestlevelofexcellence.希迈斯致力于提供高质量的产品和服务,确保客户满意。在质量、交货、可靠性方面进行持续改进并追求卓越。CMSisfullycommittedtocontinuouslyimprovingtheenvironmental-relatedperformance,complyingwithapplicablelawsandregulations,minimizingtheecologicalimpactsandmakingresourcesefficiencyandwastecontrolcorerequirementsofallouroperations.希迈斯将遵守适用的法律法规,持续提高环境相关绩效,对生态影响最小化,并将能源的高效使用和污染控制作为生产的核心要求。-MR.EmilioCassanelli卡萨乃利GeneralManager总经理Achievementofcompany'spolicyismeasuredintermsofattainmentofobjectivessetbyindividualdepartmentonayearlybasisandmonitoredonamonthlybasis.公司的方针是通过每年度各个部门的目标达成情况来衡量,每月监控目标达成情况。Topmanagementshallensurethatqualityandenvironmentalobjectives,includingthoseneededtomeetrequirementsforproduct,commitmenttopreventpollution,compliancetoalllegalrequirementsareestablishedatrelevantfunctionsandlevelswithinthecompany.Thequalityandenvironmentalobjectivesshallbemeasurableandconsistentwiththequalityandenvironmentalpolicy.管理者应确保在公司的相关职能层次上建立质量和环境目标。质量和环境目标包括满足产品要求、防止污染以及满足法律法规等内容,Baseontheinternalandexternalmeasurableresults,thesequalityandenvironmentalobjectivesarereviewedduringthemanagementreviewsregardingtheircontinuingsuitability.根据内外部衡量的结果,质量和环境目标需在管理评审时审核其持续的适宜性。ManagementshallensurethattheplanningoftheQMSandEMSiscarriedoutinordertomeettherequirementsoftheISO9001,ISO14001standardandthequalityandenvironmentalobjectivesofthecompany.Themanagement,throughMR(ManagementReview),shallalsoensurethattheintegrityoftheQMSandEMSismaintainedwhenchangestotheQMSandEMSareplannedandimplemented.ThemanagementmustreviewallchangestotheQMSandEMS.ThedocumentedQMSandEMSshallbereviewedonceayeartoensureitssuitabilityandeffectiveness.管理者应确保对质量和环境管理体系的策划是满足ISO9001,ISO14001的标准以及质量和环境目标的要求。管理者通过管理评审对质量和环境管理体系的更改进行策划和实施时,应保证质量环境管理体系的完整性并审核质量和环境管理体系的变更。为确保文件的适宜5.5.1OrganizationStructure.组织架构Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:10/27有限公司:ForproceduresandinstructionsthatrefertoG&Aandsales&Marketing,GMmeansExecutiveDirector.对程序和作业指导书涉及一般行政管理,业务部时,总经理指执行总监。ForproceduresandinstructionsthatrefertoTechnical,Quality,Supplychain,ProductionandAssembly,GMmeansPlantManager.对程序和作业指导书涉及技术、质量、供应链、生产和装配时总经理则指代工厂长。ThemanagementofCMSconsistsofGeneralManagerandManagementTeam.ManagementTeamensurestheavailabilityofresourcesessentialtoestablish,implement,maintain,andimprovethequalityandenvironmentsystem,includinghumanandspecializedskills,organizationalstructure,technologyandfinancialresources.公司的管理层包含总经理和管理组人员。管理组确保质量和环境管理体系的建立、实施、维护和改进的必要的资源能够获得。包括人员,特殊技能,组织架构,技术以及财政资源等。Roles,responsibilitiesandauthoritiesaredefined,documentedandcommunicatedtofacilitateaneffectivequalityandenvironmentalsystem.为促进质量和环境管理体系的有效性,角色、职责、权限需得到文件化规定和沟通。Departmentmanagersandsupervisorsshallbeheldresponsibleandaccountablefortheactivitiesinhisdepartment.Heshallensureadequatestaffinganddesignationofcompetentstafftoperformdepartmentfunctions,includinginternalqualityandenvironmentalaudits.KeyPersons主要人员OverallresponsiblefortheperformanceofCMSPrecisionMechanicalManufacturing(Wujiang)Co.,LTD.Establishandimprovethecompany’smanagementsystemandorganizationalstructure,andpresidedoverthecompany’-to-dyoperationsandmanagement;companymanagementanddevelopmentobjectives.负责希迈斯精密机械制造(吴江)有限公司的整体业绩,指定和实施公司的整体战略和年度运营计划;建立和健全公司的管理体系和组织结构;支持公司的日常运营和管理工作,实现公司经营管理和发展目标。ManagementRepresentative(MR):管理代表()Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:11/27有限公司:QualitymanagerisappointedbytheManagementasthemanagementrepresentative(MR)who,irrespectiveofotherdutiesandresponsibilities,hasadefinedauthorityandresponsibilityfor:质量经理除本身职责之外还被任命为管理代表。管理代表的职责包括:-EnsuringthataqualityandenvironmentalmanagementsystemisestablishedandimplementedandmaintainedinaccordancewiththerequirementsoftheinternationalstandardofISO9001:2008andISO14001:2004.确保希迈斯的质量和环境管理体系能够按照ISO9001:2008和ISO14001:2004的要求得到建立、实施和维护。-Reportingontheperformanceofthequalityandenvironmentalmanagementsystemtothetopmanagement,andneedsforimprovement向最高管理者汇报质量和环境管理体系的业绩和任何改进的需求。-Thepropercoordinationofqualityandenvironmentalrelatedissuesandactivitieswithinthecompany,withexternalcustomersandsuppliersandotherexternalpartnersandauthorities.对公司内部活动,外部客户,供应商合以及政府部门就质量和环境相关的问题进行协调。-Promotingtheawarenessofenvironmentalprotection,customerrequirementsandexpectationsthroughoutthecompany.提高满足客户要求和环境保护的意识。5.5.2InternalCommunication内部沟通TopManagementshallensurethatappropriatecommunicationprocessesareestablished.CommunicateregardingtheeffectivenessoftheQualityManagementSystemwithinthecompanyviae-mails,memos,meetingminutesorkanban.管理者应确保在公司内部建立有效的沟通过程,如邮件,备忘录,会议记录以及看板等。AnycommunicationproblemsregardingqualityandenvironmentalmanagementsystemarereportedtotheManagementRepresentativesforcorrectiveactions.质量和环境的任何沟通问题都应报告给管理者代表并采取改善措施。CMSestablishesasystemtocollectbothinternalandexternalinformationrelatedtoenvironmentalmanagementsystem.Andtheseinformationreceivedshallbeconsideredduringthesettingofenvironmentalobjectivesandtargets.公司就环境管理体系建立一个收集内部和外部信息的系统。这些信息将在设定环境目标时进行考量。Whensignificantenvironmentoccurs,e.g.fire,explosion,environmentalcontaminationormajoroccupationalinjury,uponapprovalofthegeneralmanager,CMSwillcommunicateinformationtotherelateddepartment.当发生重大环境影响时,如:火灾、爆炸、环境污染及重大工伤,经公司总经理批准,将主动和相关方进行沟通。ManagementReviewisheldatleastonceayearandmaybemorefrequentdependingonthenecessity.ParticipantsofthemanagementreviewconsistsofGeneralManager,manager,supervisorandManagementTeam.Thereviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalityandenvironmentalmanagementsystem,includingthequalityandenvironmentalpolicyandqualityandenvironmentalobjectives.管理评审至少每年进行一次,可根据内部需要增加评审的次数。参加管理评审的人员应包括总经理,经理,部门主管等管理层。评审应包括质量和环境体系改进的机会和变更的需要、质量和环境方针,质量和环境目标。1)Resultsofaudits,includinginternalandexternalsystemaudit,customeraudit,processauditandnonconformitycorrectiveactionvalidation审核结果:包含内外部体系审核,客户审核,制程审核以及一些不符合项的验证2)Interestedpartyfeedback,includingcustomersatisfaction,interestedpartycomplaint,customerrequirementandsuggestions相关方反馈:包含客户满意度,相关方抱怨要求及建议等。3)Processperformanceandproductconformity,includingperformancetrends过程的业绩和产品的符合性,包含业绩趋势图4)Statusofpreventiveandcorrectiveactionsforprocessandproduct过程,产品的预防和纠正措施的状况5)Follow-upactionsfrompreviousmanagementreviews以往管理评审的跟踪措施Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:12/27有限公司:6)Changesthatcouldaffectthequalityandenvironmentalmanagementsystemincludingthechangesoforganizationalstructure,lawsandregulationsinternalandexternalchangesintheenvironment12)Theenvironmentalperformanceoftheorganization环境方面的绩效RecordsofsuchreviewsshallbemaintainedandtheQualityDepartmentshallfollow-uponallthesuggestionsorrecommendationsthatmentionedduringthemeeting.对管理评审的记录应予以保存和维护。质量部门应对会议中提出的建议事项进行进一步追踪。CMSwillestablishandmaintainaproceduretoidentifytheenvironmentalaspectsofouractivities,productsandservicesofwhichwecancontrolwithinthedefinedscopeofEMSandexpectstohaveaninfluence.Theidentificationwillcoverthedirectandindirectaspectscoveringnormal,abnormalandemergencysituations,plannedornewdevelopments,ormodifiedtheactivities,productsandservices.Theidentifiedaspectswillbeevaluatedinordertodeterminethosethathaveorcanhavesignificantimpactsontheenvironment.CMSwillensurethattheaspectsrelatedtothesesignificantimpactsareconsideredinsettingitsenvironmentalobjectivesandtargets.Theorganizationshallensurethatthesignificantenvironmentalaspectsareconsideredindeveloping,implementingandmaintainingitsEMS.Thedocumentandinformationshallbekeptuptodate.公司应建立并维护确定环境管理体系范围内的活动、产品及服务中能够控制和施加影响的环境因素。此时还应考虑到正常,异常和紧急状态下的直接和间接环境因素,已纳入计划的或新的开发、变更的活动、产品和服务;判定那些对环境具有重大影响,或可能具有重大影响的因素(即重要环境因素)。公司在建立目标指标,建立、实施和保持环境管理体系时,对重要环境因素加以考虑,并将这方面的信息形成文件并及时更新。5.8LegalandotherRequirements法律法规及其它要求CMSshallestablishaproceduretoidentifyandhaveaccesstotheapplicablelegalrequirementstodeterminehowtheserequirementsapplytoitsenvironmentalaspect.AndCMSensurethatapplicablelegalrequirementsandotherrequirementstowhichtheorganizationsubscribearetakenintoaccountinestablishing,implementingandmaintainingitsenvironmentalmanagementsystem.公司将建立程序识别和获得适用的法律要求来确定这些要求如何应用其环境方面。公司确保适用的法律要求和其他要求在公司建立、实施和保持环境管理体系时予以考虑。Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:13/27有限公司:TopManagementshalldetermineandprovideresourcesneededtoimplementandmaintaintheQualityandEnvironmentalManagementSystemandcontinuallyimproveitseffectivenessandenhancecustomersatisfaction.最高管理者应确定并提供实施和保持质量和环境管理体系和持续改进其有效性、增强客户满意度所需的资源。Itistheresponsibilityofdepartmentheadstoidentifyqualificationrequirementsofpersonnelassignedtodefinedactivities,whichaffectproductqualityorenvironmentalperformance.Qualificationrequirementsincludeeducation,training,skillsandexperienceasappropriate.Therequirementsneedtobedocumentedandtrainingisprovidedtoemployeesorotheractionsaretakeninordertomeetdefinedqualifications.部门主管确定参与相关活动影响产品或环境人员的资格要求。资格要求包括教育、培训、技能和适当的经验。相关的要求需要形成文件化的岗位说明书。为满足各岗位能力的需求,对员工应经行相应的培训等。CMSshallbeawareoftheimportanceoftheroleandresponsibilityinachievingconformitywithrequirementsofthequalityandenvironmentsystem.公司应意识到质量和环境意识对达成符合性要求及相关岗位的重要性。FacilityMaintenanceSectionmaintainsthebuildings,workspaceandassociatedutilities.ITshallprovidesupportingservices(e.g.hardware,software,andcommunicationorinformationsystems)whichneededtoachieveconformitytoproductrequirements.为达到产品的符合性,满足相关的要求,设施维护部门应维护房屋,工作场等相关设施。信息技术应提供相关的支持性服务(如硬件,软件,通讯或信息系统)。CMSestablishesanemergencyplanidentifyingpotentialaccidents&emergencysituations,preventing&mitigatingpotentialenvironmentalimpactsthatmaybeassociatedwiththem,andperiodicallytestingsuchprocedureswherepractical.Thisplanshallbereviewedperiodicallytocheckthenecessitytoberevised.公司建立应急计划并识别潜在事故和紧急情况,预防和缓解与其相关的潜在的环境影响。定期对计划进行测试,确认是否有必要修改。6.4WorkEnvironment工作环境Thecompanyhasdeterminedandmanagedtheworkenvironmentneededtoachieveconformitytoproductrequirementsthrough5Scampaignandgeneralcleaning.Wherenecessary,therelevantinfrastructureasin6.3willbeprovidedandmaintainedtoachievetherequiredworkenvironment.公司通过5S活动和一般清洁等管控工作场所的环境来满足实现产品的符合性的工作环境需求。提供与维护与6.3的相关的基础设施来确保所需要的工作环境。PlanningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesoftheQualityManagementSystemandtherequirementsoftheEnvironmentalManagementsystem.Processesneededfortheproductrealizationhasbeenplannedanddeveloped.QualityPlanningisalsointheformofprocedureswhichdefinestheworkingflow,workinginstructionswhichdefinestheoperation,toolsused,methodsandsomeotherrelateddocuments.质量策划通过程序文件定义作业的流程,作业指导书以及其他相关的文件定义作业的方法,使用的工具等。Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:14/27有限公司:7.2Customer-RelatedProcesses与顾客有关的过程CMSdefinesproductrequirementsincludethosespecifiedbythecustomer,thosenotstatedbythecustomerbutnecessaryfortheintendeduse,statutoryandregulatoryrequirementsrelatedtotheproduct,deliveryandpost-deliveryactivities,andanyadditionalrequirementsdefinedbyCMS.希迈斯定义产品需求包括客户明确的要求,以及非客户规定但必要的预期用途的要求、相关的法律和法规要求、产品交付及交付后活动,以及其他任何附加的要求。CMSreviewsproductrelatedrequirementsperthecustomerdrawingsandspecifications.Thesereviewsareconductedpriortoanycommitmenttosupplytocustomertoensurethatproductrequirementsaredefined.Recordsoftheresultsofthereviewandactionsarisingfromthereviewaremaintained.Whereproductrequirementarechanged,needtoensurethatrelevantdocumentsareamendedandthatrelevantemployeesaremadeawareofthechangedrequirements.希迈斯根据客户的图纸和规格来确定客户的相关的要求。在承诺供应产品给客户之前,需要对客户的要求评审和定义。评审结果以及矫正措施进行维护。产品需求有变化时,需要确保相关文件修改,相关员工了解变化的需求。Customercommunicationisvitaltocustomersatisfaction.Thecommunicationwithcustomersshouldbebefore,afterandthewholeprocessofproductrealization.Thecommunicationshallincludeproductinformation,inquires,contractsororderhandling,includingamendments,customerfeedbackandcustomercomplaints.与客户沟通对于客户满意度是至关重要的。与顾客的沟通应在产品实现之前,之中,之后的整个过程中实现。沟通的内容包括产品信息,合同,订单的处理修改,顾客的反馈,包括顾客抱怨等。ThisclauseisnotapplicabletoCMS(Wujiang)Co.,Ltd,asdesignanddrawingsareprovidedbythecustomers,CMSisnotauthorizedtorevisethedrawings.此条款对于希迈斯机械制造(吴江)有限公司不适用,因设计和图纸都是由客户提供的,本公司无修改的权力。Purchasingproceduresareinplacetoensurethatpurchasedproductsmeettherequirements.Thetypeandextentofcontrolappliedtothesupplierandpurchasedproductsshallbedependentupontheeffectofthepurchasedproducts.CMSshallevaluateandselectsuppliersbasedontheirabilitytosupplyproductinaccordancewithinternalrequirements.Criteriaforselection,evaluationandre-evaluationshallbeestablished.Recordsoftheseevaluationandfollowingactionsshallberecorded.制定采购程序以确保采购的产品符合要求。控制的方式和程度根据采购产品对之后的实现过程及其输出的影响确定。公司根据供方按本公司的要求提供产品的能力评价和选择供方,并制定选择、评价和重新评价的原则予以规定,评价的结果和跟踪措施应予以记录。SupplierswhodirectlydealwithsignificantaspectsshallbemadeawareofCMS’senvironmentalpolicy.提供与环境有关的产品和服务的供应商应了解公司的环境方针。7.4.2PurchasingInformation采购信息Internalrequisitionandpurchaseordersusedfortheplacementofordersshallcontainallthepertinentinformation.Priortoreleasetosuppliers,purchaseordershallbereviewedandfinallyapprovedbyGeneralManager.用于下单的请购单和采购单必须含有所有相关的信息。在发给供应商之前,采购定单需要审核并最终由总经理批准。IncomingInspection进料检验Doc.code编号:CMS-QEM01Rev.版本:03Page第/页:15/27有限公司:InternalinspectioniscarriedoutbytrainedinspectorsinaccordancetoQualityInspectionInstruction(QII),andbeenrecordedininspectionsheet.内部进料检验是由受过训练的检验员按照质量检验指导书进行,并记录在检验记录表中。Verificationatsupplierspremises.供应商现场的确认VerificationarrangementandthemethodofproductreleaseshallbespecifiedinpurchasingdocumentsshouldCMSorcustomerchoosetoverifypurchasedproductatsupplier’spremises.当本公司或客户需要在供应商现场对材料进行验证时,则验证的安排以及产品放行的方法必须在采购的文件中进行定义。Production&AssemblyDepartmentshallmanufactureandexercisecontrolonallproductionprocesses,inaccordancetoproceduresandworkinstructions.制造和装配部必须根据程序和作业指导书对生产和装配的过程进行管控。ProductionandAssemblyManagershallensurethatsuitableequipmentisadequateattheworkshopandpersonnelinvolvedinproductionarewelltrainedandunderstandtherequirementsofthejob.Productionsupervisorshallensurethatoperatorscomplywithstatedproceduresandworkinginstructions.Effectivefeedbacksystemshallbeenforcedtoenablenotificationofanyabnormality.NonconformitiesataboveallowablelimitsshallbetreatedasperSection8.2(ControlofNonconformingProduct).制造和装配部经理需确保工作现场有足够的适宜的工具和设备,并且生产相关的人员得到充分的培训,了解工作的要求。生产主管必须确保员工能够按照作业指导书进行作业。需要有效的信息反馈系统能在异常发生时得到有效的反馈。对于不合格的产品应根据8.2节(不合格品管理程序)进行处理。Whenenvironmentalaspectsareconsideredtobesignificant,CMSshallestablishrelatedcontrolmethodstoreduceoreliminatestheimpacttotheenvironmentandtoseekforconformitytothepolicy.当评价与所确定的重要环境因素运行时,为确保其在运行过程中能够控制或减少对环境的影响,应建立相应的控制措施,以满足环境方针。7.5.2ValidationofProcessesforProductionandServiceProvision生产和服务提供的过程确认CMSvalidatesprocessesforproductionandserviceprovisionwheretheresultingoutputcannotbeverifiedbysubsequentmonitoringormeasurement.Validationdemonstratestheabilityoftheprocessestoachieveplannedresults.CMSestablishesdefinedcriteriaforreviewandapprovaloftheprocess,approvalofequipmentandqualificationofemployees,useofspecificmethodsandprocedures,requirementsforrecordsandre-validation.CMSneedtovalidatetheweldingprocessandestablishrelateddocumenttocontroltheprocess.当输出不能由后续的监视或测量验证时,公司对这样的过程进行验证。验证证明了过程的能力和策划的结果。公司定义标准来审查设备的认可和人员资质的鉴定,使用特定的方法和程序进行记录和再验证,公司需要进行过程确认的工序为焊接工序,以建立相关的文件对其进行管控。Theidentificationandtraceabilityshallbeimplementedthroughouttheproductrealizationto
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