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質量手冊QUALITYMANUAL文件編號:QM-01DocumentNo.:QM-01版本:02Version:02頁次:PAGE1ofNUMPAGES45Page:PAGE1ofNUMPAGES45質量管理體系文件QualityManagementSystemDocument制定Preparedby審核:Checkedby:批準:Approvedby:日期Date日期Date日期DateDistributionlist分發簽收清單客服部CSDept日期Date開發部D&DDept日期Date物料部MaterialDept日期Date品質部QADept日期Date生產部Prod.Dept日期Date貨倉部WH.Dept日期Date運作部OPDept.日期Date采購開發部SourcingDept日期Date工程部EngineeringDept日期Date人事&行政部HR&Admin.Dept日期DateRevisionHistory修訂記錄REVISION版本DESCRIPTIONOFCHANGE修訂內容ORIGINATOR起草人RELEASEDATE發行日期目錄Content前言Prelude序言…………………6Foreword公司簡介……………6Companyprofile質量方針……………7Qualitypolicy范圍Scope產品范圍…………….7Productscope場所范圍…………….7Sitescope刪節說明…………….7Cancellation引用標準………………….7Normativereference術語和定義……………….7-8Terms質量管理體系Qualitymanagementsystem總要求……………….8-9Generalrequirements文件要求…………….9-11Documentationrequirements管理職責Managementresponsibility管理承諾…………….11Managementcommitment以顧客為中心……………………….11Customerfocus質量方針…………….12Qualitypolicy策劃………………….12Planning職責、權限和溝通………………….12-13Responsibility,authorityandcommunication管理評審…………….13-14Managementreview6.資源管理Resourcemanagement資源提供…………….14-15Provisionofresources人力資源…………….15Humanresources基礎設施…………….15-16Infrastructure工作環境…………….16Workenvironment7.產品實現Productrealization產品實現的策劃…………………….16Planningofproductrealization與顧客有關的過程………………….16-18Customer-relatedprocesses設計和開發………….18-20Designanddevelopment采購………………….20-21Purchasing生產………………….21-23Production監視和測量裝置的控制…………….23-24Controlofmonitoringandmeasuringdevices8.測量、分析和改進Measurement,analysisandimprovement總則………………….24General監視和測量………….24-26Monitoringandmeasurement不合格品的控制…………………….26Controlofnonconformingproduct數據分析……………..26-27Analysisofdata改進………………….27-28Improvement9.附件Attachments附件1:質量管理體系流程圖……………………..29-30Attachment1:QMSFlowchart附件2:組織架構圖………………..31Attachment2:OrganizationalStructure附件3:部門職責對照表…………..………………32-34Attachment3:DepartmentalResponsibilityDeployment附件4:質量手冊和程序清單……………………..35-36Attachment4:QMSManualandProcedureList附件5:部門職責一覽表…………37-41Attachment5:Departmentalresponsibility附件6:質量目標分解表…………42Attachment6:QualityObjectives附件7:QMS管理者代表任命書………………...43Attachment7:AppointmentofQMSManagementRepresentative附件8:培訓表格…………………...44Attachment8:TrainingForm前言Prelude序言Foreword企業要發展壯大,就必須有先進的管理方法.在結合本廠產品、實際情況、《ISO9001:2008質量管理體系要求》標準的前提下,制定了本《質量手冊》.Businessexpansionalwaysdependsonadvancedmanagerialmethods.Hereby,wehaveformulatedthisQualityManualconsideringthecharacteristicsofourproducts,managerialstatusandISO9001:2008.本手冊規定了公司質量方針、質量目標及建立、實施和改進質量管理體系的基本要求.ThisManualhasdefinedqualitypolicy,qualityobjectives,andthebasicrequirementsforestablishing,implementingandimprovingqualitymanagementsystem全體員工必須依據本手冊及其支持性文件——程序文件、操作指導書、技術規范、國家法律、法規的規定進行運作,創造一種持續滿足顧客要求的機制。PersonnelinXXXXXshallgobythismanualanditssupportivedocuments,cedures,workinstructions,specifications,andlegalrequirementstocreateamechanismsatisfyingcustomerrequirementscontinually公司簡介Companyprofile公司名字:
:xxxxx)/Companyname
:XXXXXLtd(Include)企業性質
:港資Capitalorigin:HKinvestment成立時間:xxxxx成立于Foundedin:地址Address:主要產品Mainproducts:手袋及其它縫紉制品。Bagsandothersewingproducts.主要生產流程Mainproductionprocesses:開料→貼合/熱壓/電壓/燙畫→車縫→包裝Cutting→Lamination/Thermoforming/Highfrequency/Transfersticker→Sewing→Packing主要生產設備Mainproductionequipment:裁床、貼合機、熱壓機、電壓機、針車等.Cuttingmachine,laminationmachine,thermoformingmachine,highfrequencymachine,sewingmachine,etc.主要測試儀器Mainmeasuringdevices:鹽霧試驗機、破裂強度測試儀、卡尺、硬度計、千分尺、拉力計、推拉力計、電子天平、驗布機及及其它布料測試設備等.Saltspraytestmachine,brokenstrengthtester,caliper,hardnesstester,microscope,pullgage,push-pullgage,electronicweightscale,fabricinspectionmachineandotherfabrictestingequipment.質量方針Qualitypolicy:持續過程優化,追求顧客滿意.Continualimprovementandcustomersatisfaction.范圍Scope產品范圍Productscope手袋及其它縫紉制品。Bagsandothersewingproducts.場所范圍Locationscope刪節說明Cancellation本手冊“第7.3條設計和開發”只適用于xxxxx,不適用于xx.Theelements“7.3designanddevelopment”isonlyapplicableforxxxLbutnotapplicableforxx.因為xx依據xxxxx的樣板、技術圖紙進行制作樣板,在樣板得到xxxxx的承認之后進行產品生產,故本要素不適用于xxxxx.Thecauseofnotapplicable:becausexxcarriesoutsamplemakingbasedonbenchmarkingsamplesorspecificationprovidedbyxx,andxxcommencemassproductiononlyaftersamplehasbeenapprovedbyxxx引用標準Normativereference《ISO9000:2005質量管理體系—基礎和術語》ISO9000:2005QualityManagementSystemFundamentalsandvocabulary《ISO9001:2008質量管理體系要求》ISO9001:2008QualityManagementSystemRequirements術語和定義Terms質量Quality一組固有特性滿足要求的程度.Degreetowhichasetofinherentcharacteristicsfulfillsrequirements注1:術語“質量”可使用形容詞如差、好或優秀來修飾Note1:theterm“quality”canbeusedwithadjectivessuchaspoor,goodorexcellent注2:“固有的”(其反義是“賦予的”)就是指在某事或某物中本來就有的,尤其是那種永久的特性Note2:“Inherent”,asopposedto“assigned”,meansexistinginsomething,especiallyasapermanentcharacteristics顧客滿意Customersatisfaction顧客對其要求已被滿足的程度的感受Customer’sperceptionofthedegreetowhichthecustomer’srequirementshavebeenfulfilled注1:顧客投訴是一種滿意程度低的最常見的表達方式,但沒有投訴并不一定表明顧客很滿意Note1:customercomplaintareacommonindicatoroflowcustomersatisfactionbuttheirabsencedosenotnecessarilyimplyhighcustomersatisfaction注2:即使規定的顧客要求符合顧客的愿望并得到滿足,也不一定確保顧客很滿意Note2:evenwhencustomer’srequirementshavebeenagreedwiththecustomerandfulfilled,thisdoesnotnecessarilyensurehighcustomersatisfaction顧客Customer接受產品的組織或個人Organizationorpersonthatreceivesaproduct供應商/供方Supplier提供產品的組織或個人Organizationorpersonthatprovidesaproduct過程Process一組將輸入轉化為輸出的相互關聯或相互作用的活動Setofinterrelatingorinteractingactivitieswhichtransformsinputsintooutputs產品Product過程的結果Resultofaprocess合格Conformity滿足要求Fulfillmentofarequirement不合格Nonconformity未滿足要求Non-fulfillmentofarequirement預防措施Preventiveaction為消除潛在不合格或其他潛在不期望情況的原因所采取的措施Actiontoeliminatethecauseofapotentialnonconformityorotherpotentialundesirablesituation糾正Correction為消除已發現的不合格所采取的措施Actiontoeliminatedetectednonconformity糾正措施Correctiveaction為消除已發現的不合格或其他不期望情況的原因所采取的措施Actiontoeliminatethecauseofadetectednonconformityorotherundesirablesituation文件Document信息及其承載媒體Informationanditssupportingmedium記錄Record闡明所取得的結果或提供所完成活動的證據的文件Documentstatingresultsachievedorprovidingevidenceofactivitiesperformed質量管理體系Qualitymanagementsystem總要求Generalrequirements本公司將按照本《質量手冊》的要求建立質量管理體系,形成文件,加以實施和保持,并持續改進其有效性.Ourcompanyshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisQualityManual本公司將:Ourcompanyshall識別質量管理體系所需的過程及其在公司內的應用;Identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughoutourcompany確定這些過程的順序和相互作用(見附件1:質量管理體系流程圖);Determinethesequenceandinteractionoftheseprocesses(seeattachment1:QMSFlowchart)確保為這些過程的有效運作和控制所需的準則和方法;Determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective確保可以獲得必要的資源和信息,以支持這些過程的運作和監視;Ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationoftheseprocesses監視、測量和分析這些過程;Monitor,measureandanalyzetheseprocesses,and實施必要的措施,以實現對這些過程所策劃的結果和對這些過程的持續改進Implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses本公司必須按照《ISO9001:2008質量管理體系要求》管理上述的過程;TheseprocessesshallbemanagedbyourcompanyinaccordancewithISO9001:2008QualityManagementSystem針對本公司所外包的任何影響產品符合性的過程,本公司將確保對其予以識別和控制.Wherewechoosetooutsourceanyprocessthataffectsproductconformitywithrequirements,weshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.本公司的外包活動:部分工序,按照本公司《生產管理程序》進行控制.Someprocesseswillbeoutsourcedsometimes,andshallbeincontrolaccordingtoProductionManagementProcedure.文件要求Documentationrequirements總則General質量體系文件包括:Documentationofthequalitymanagementsystemconsistsof質量方針和質量目標;Qualitypolicyandqualityobjectives質量手冊;QualityManual《ISO9001:2008質量管理體系要求》所要求的程序文件和本公司確定的其它程序文件,見附件4:《質量手冊和程序清單》;DocumentedproceduresrequiredbyISO9001:2008QualityManagementSystemandourcompany,seeattachment4:本公司為確保過程有效策劃、運作和控制所需的文件;Documentsneededbyourcompanytoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andQMSManualandProcedureList《ISO9001:2008質量管理體系要求》所要求的記錄(見本手冊第4.2.4條)RecordsrequiredbyISO9001:2008QualityManagementSystem(see4.2.4文件的形式:紙質或電子文件.Mediaofdocuments:paperorelectroniccarrier質量手冊QualityManual本公司編制和保持本《質量手冊》,且包括:WeshallestablishandmaintainthisQualityManualthatincludes質量管理體系的范圍,包括任何刪節的細節和合理性,見本手冊第1章節:“范圍”;Thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusion(seechapter1:Scope)為質量管理體系編制的形成文件的程序或對其引用;Thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and質量管理體系過程的相互作用的表述.Adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem本《質量手冊》由管理者代表編制、總經理審核;ThisQualityManualshallbedraftedbyManagementRepresentative,andshallbeapprovedbyGeneralManager本《質量手冊》按照《文控程序》進行控制.ThisQualityManualshallbecontrolledbasedonDocumentControlProcedure文件控制Controlofdocument質量管理體系所要求的文件必須予以控制.質量記錄是一種特殊類型的文件,應按照第4.2.4條款的要求進行控制;Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4建立《文控程序》,以規定以下方面所需的控制:DocumentControlProcedureshallbeestablishedtodefinethecontrolsneeded文件發布前得到批準,以確保文件是充分與適宜的;toapprovedocumentsforadequacypriortoissue必要時,對文件進行評審與更新,并再次批準;toreviewandupdateasnecessaryandre-approvedocuments確保文件的更改和現行修訂狀態得到識別;toensurethatchangesandthecurrentversionstatusofdocumentsareidentified確保在使用處可獲得有關版本的適用文件;toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse確保文件保持清晰、易于識別;toensurethatdocumentsremainlegibleandreadilyidentifiable確保外來文件得到識別,并控制其分發;toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and防止作廢文件的非預期使用,若因任何原因而保留作廢文件時,對這些文件進行適當的標識.topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose質量記錄的控制Controlofqualityrecords建立《記錄管理程序》,以便:RecordControlProcedureshallbeestablishedto建立并保持質量記錄,以提供符合要求和質量管理體系有效運行的證據;establishandmaintainqualityrecordsinordertoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem確保質量記錄保持清晰、易于識別和檢索;ensurerecordscanremainlegible,readilyidentifiableandretrievable規定質量記錄的標識、貯存、檢索、保存期限和處置所需的控制.todefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords管理職責Managementresponsibility管理承諾Managementcommitment總經理將通過以下活動,對建立、實施質量管理體系并持續改進有效性的承諾提供證據:GeneralManagershallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby向公司全體成員傳達滿足顧客和法律法規要求的重要性;communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,制定質量方針;establishingthequalitypolicy制定質量目標,并定期進行統計和檢討;ensuringthatqualityobjectivesareestablished進行管理評審;conductingmanagementreviews,and提供適當的資源;ensuringtheavailabilityofresources以顧客為中心Customerfocus總經理以增強顧客滿意為目的,確保顧客的要求得到確定并予以滿足;GeneralManagershallensurethatcustomerrequirementsaredeterminedandmetwiththeaimofenhancingcustomersatisfaction建立和實施《客戶服務程序》,包括對顧客訂單進行有效評審及顧客滿意度的調查.CustomerServiceProcedureshallbeestablishedandimplemented,includingthecustomerOrderReviewandCustomerSatisfactionSurvey.質量方針Qualitypolicy總經理應確保質量方針:GeneralManagershallensurethatthequalitypolicy與公司的宗旨想適應;isappropriatetothepurposeofourcompany包括對滿足要求和持續改進質量管理體系有效性的承諾;includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem提供制定和評審質量目標的框架;providesaframeworkforestablishingandreviewingqualityobjectives在組織內得到溝通和理解;iscommunicatedandunderstoodwithintheorganization,and在持續適宜性方面得到評審.Isreviewedforcontinuingsuitability本公司的質量方針,見“前言”章節.Aboutqualitypolicyofourcompany,seetheForewordtothisManual策劃Planning質量目標Qualityobjectives總經理應確保在公司的相關職能和層次上建立質量目標,質量目標包括滿足產品要求所需的內容;GeneralManagershallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct,areestablishedatrelevantfunctionsandlevelswithintheorganization質量目標應是可測量的,并與質量方針保持一致;Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy本公司的質量目標見附件6:《質量目標分解表》Aboutthequalityobjectivesofourcompany,seeattachment6,QualityObjectives質量管理體系策劃Qualitymanagementsystemplanning總經理應確保:GeneralManagershallensurethat對質量管理體系進行策劃,以滿足質量目標和本手冊第4.1條款的要求;theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1ofthisManual,aswellasthequalityobjectives,and在對質量管理體系的更改進行策劃和實施時,保持質量管理體系的完整性.theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented職責、權限和溝通Responsibility,authorityandcommunication職責和權限Responsibilityandauthority總經理應確保組織的職責、權限及其相互關系的得到規定和溝通;GeneralManagershallensuretheresponsibilitiesandauthoritiesaredefinedandcommunicatedwithinourcompany各部門的職責與權限,見附件2:《組織架構圖》;附件3:《部門職責對照表》;附件5:《部門職責一覽表》Aboutdepartmentalresponsibilitiesandauthorities,seeattachment2:OrganizationalStructure;andattachment3:DepartmentalResponsibilityDeployment管理者代表ManagementRepresentative總經理應任命管理者代表(見附件7:《管理者代表任命書》),以便履行下述職責與權限:GeneralManagershallappointamemberofmanagementwho(seeattachment7:AppointmentofQMSManagementRepresentative),irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatinclude確保質量管理體系所需的過程得到建立、實施和保持;ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained向總經理報告質量管理體系的業績和任何改進的需求;reportingtoGeneralManagerontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and確保在公司內提高滿足顧客和法律法規要求的意識;ensuringthepromotionofawarenessofcustomerrequirementsthroughoutourcompany,and與質量管理體系有關事宜的外部聯絡,如:認證機構、咨詢機構,等.liaisingwithexternalpartiesonmattersrelatingtothequalitymanagementsystem內部溝通Internalcommunication總經理應該確保在組織內建立適當的溝通過程,并確保對質量管理體系的有效性進行溝通;GeneralManagershallensurethatappropriatecommunicationprocessesareestablishedwithinourcompanyandthatcommunicationtakesplacesregardingtheeffectivenessofthequalitymanagementsystem本公司的溝通途徑:電子郵件、信件、會議,等Communicationchannelsinourcompanyincludeemail,letter,meeting,etc管理評審Managementreview總則General總經理應確保建立、實施和改進《管理評審程序》,以便GeneralManagershallestablish,implementandimproveManagementReviewProcedureto最少一年一次評審公司的質量管理體系,以確保其持續的適宜性、充分性和有效性;reviewthequalitymanagementsystemofourcompanyatleastyearlytoensureitscontinuingsuitability,adequacyandeffectiveness,and評審應包括評價質量管理體系改進的機會和變更的需要,包括質量方針和質量目標;assessopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives保留管理評審記錄Recordsfrommanagementreviewshallbemaintained評審輸入Reviewinput管理評審的輸入必須包括以下方面的信息:Theinputtomanagementreviewshallincludeinformationon質量方針的適宜性;suitabilityofthequalitypolicy質量目標的適宜性;suitabilityofqualityobjectives外/內部審核的結果;resultsofbothinternalandexternalaudits顧客反饋;customerfeedback過程的業績和產品的符合性;processperformanceandproductconformity預防和糾正措施的狀況;statusofpreventiveandcorrectiveactions以往管理評審的跟蹤措施;follow-upactionsfrompreviousmanagementreviews經策劃的可能影響質量管理體系的變更;changesthatcouldaffectthequalitymanagementsystem,and改進的建議recommendationsforimprovement評審輸出Reviewoutput管理評審的輸出應該包括與以下方面有關的任何決定和措施:Theoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto質量管理體系及其過程有效性的改進;Improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses與顧客有關的產品的改進;improvementofproductrelatedtocustomerrequirements,and資源的需求.resourceneeds資源管理Resourcemanagement資源提供Provisionofresources總經理應確定并提供所需要的資源,以:GeneralManagershalldetermineandprovidetheresourcesneeded實施、保持質量管理體系并持續改進其有效性;toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,and通過滿足顧客要求,增強顧客滿意.toenhancecustomersatisfactionbymeetingcustomerrequirements人力資源Humanresources總則General基于適當的教育、培訓、技能和經驗,從事影響產品質量工作的人員應是能夠勝任的.Personnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience能力、意識和培訓Competence,awarenessandtraining建立、實施和改進《培訓程序》,以:TrainingProcedureshallbeestablished,implementedandimprovedto確定從事影響產品質量工作的人員所必要的能力;determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality提供培訓或采取其它措施以滿足這些需求;providetrainingortakeotheractionstosatisfytheseneeds評價所采取措施的有效性;evaluatetheeffectivenessoftheactionstaken確保員工意識到所從事活動的相關性和重要性,和如何為實現質量目標作出貢獻;ensurethatthepersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,and保持教育、培訓、技能和經驗的適當記錄.maintainappropriaterecordsofeducation,training,skillsandexperience基礎設施Infrastructure公司應確定、提供并維護為達到產品要求的符合性所需的基礎設施,如:Ourcompanyshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicable建筑物、工作場所和相關設施;buildings,workspaceandassociatedutilities過程設備,包括硬件和軟件;Processequipment(bothhardwareandsoftware),and支持性服務,如運輸或通訊supportingservices(suchastransportorcommunication)建立、實施和改進《生產設備管理程序》,以對生產設備進行正確的操作、保養和維修;ProductionEquipmentManagementProcedureshallbeestablished,implementedandimprovedtoproperlyoperate,maintainandrepairproductionequipment建立、實施和改進《監控與測量設備控制程序》,以對測量和監視裝置進行正確的操作、保養和校正;MonitoringandMeasuringDeviceManagementProcedureshallbeestablished,implementedandimprovedtoproperlyoperate,maintainandcalibratemeasuringandmonitoringdevices建立、實施和改進《模具管理程序》,以對模具裝進行驗證和保養.MoldManagementProcedureshallbeestablished,implementedandimprovedtoverifyandmaintainmolds.工作環境Workenvironment公司應確定和管理為實現產品要求符合性所需的工作環境。Ourcompanyshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements,產品實現Productrealization產品實現的策劃Planningofproductrealization本公司將策劃和開發產品實現所需的過程.產品實現的策劃應與質量管理體系其他過程的要求相一致.Ourcompanyshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesofthequalitymanagementsystem在對產品實現進行策劃時,應確定以下方面的適當內容:Inplanningproductrealization,weshalldeterminethefollowing,asappropriate產品的質量目標和要求;qualityobjectivesandrequirementsfortheproduct針對產品確定過程、文件和資源的需求;theneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproduct產品所需求的驗證、確認、監視、檢驗和試驗活動,和產品接收準則;requiredverification,validation,monitoring,inspectionandtestactivitiesspecifiedtotheproductandthecriteriaforproductacceptance為實現過程及其產品滿足要求提供證據所需的記錄.recordsneededtoprovideevidencethattherealizationprocessesandresultingproductmeetrequirements策劃的輸出形式應適于本公司的運作方式.Theoutputofthisplanningshallbeinaformsuitableforourcompany’smethodofoperations注1:對應用于特定產品、項目或合同的質量管理體系的過程(包括產品實現過程)和資源作出規定的文件可稱之為質量計劃;Note1:Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingtheproductrealizationprocesses)andtheresourcestobeappliedtoaspecificproduct,projectorcontract,canbereferredtoasaqualityplan注2:也可以將條款7.3的要求應用于產品實現過程的開發.Note2:Theorganizationmayalsoapplytherequirementsgivenin7.3tothedevelopmentofproductrealizationprocesses與顧客有關的過程Customer-relatedprocesses與產品有關的要求的確定Determinationofrequirementsrelatedtotheproduct公司必須確定:Ourcompanyshalldetermine顧客規定的要求,包括對交付及交付后活動的要求;requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost-deliveryactivities顧客雖然沒有明示,但規定的用途或已知和預期用途所必需的要求;requirementsnotstatedbythecustomerbutnecessaryforspecifiedorintendeduse,whereknown與產品有關的法律法規要求;statutoryandregulatoryrequirementsrelatedtotheproduct,and本公司確定的任何附加要求.anyadditionalrequirementsdeterminedbyourcompany與產品有關的要求的評審Reviewofrequirementsrelatedtotheproduct公司建立、實施和改進《客戶服務程序》,以評審與產品有關的要求;CustomerServiceProcedureshallbeestablished,carriedoutandimprovedtoreviewtherequirementsrelatedtotheproduct評審在向顧客作出提供產品的承諾之前進行(如:提交標書、接受合同或訂單、接受合同或訂單的更改),并確保:thisreviewshallbeconductedpriortoourcommitmenttosupplyaproducttothecustomer(e.g.submissionoftenders,acceptanceofcontractsororders,acceptanceofchangestocontractsororders)andshallensurethat產品要求得到規定;productrequirementsaredefined與以前表述不一致的合同或訂單的要求已予以解決;contractororderrequirementsdifferingfromthosepreviouslyexpressedareresolved,and有能力滿足規定的要求.wehavetheabilitytomeetthedefinedrequirements評審結果及評審所引發的措施的記錄必須予以保持;Recordsoftheresultsofthereviewandactionsarisingfromthereviewshallbemaintained若顧客提供的要求沒有形成文件,業務人員在接收顧客要求前應要求顧客提供書面文件,本公司不接受口頭指示;Wherethecustomerprovidesnodocumentedstatementofrequirement,thesalespersonnelshallrequestthecustomertoprovidethedocument.XXXXXdoesnotacceptanyverbalinstructions.若產品要求發生變更,應確保相關文件得到修改,并確保相關人員知道已變更的要求.Whereproductrequirementsarechanged,weshallensurethatrelevantdocumentsareamendedandthatrelevantpersonnelaremadeawareofthechangedrequirements顧客溝通Customercommunication本公司將對以下有關方面確定并實施與顧客溝通的有效安排:Ourcompanyshalldetermineandimplementeffectivearrangementforcommunicatingwithcustomersinrelationto產品信息;productinformation問詢、合同或訂單的處理,包括對其的修改;enquiries,contractsororderhandling,includingamendments,and顧客反饋,包括顧客投訴.customerfeedback,includingcustomercomplaints設計和開發Designanddevelopment本公司建立、實施和改進《新產品設計與開發程序》以確保產品的固有品質、效力、安全性及顧客滿意度.NewProductDesignandDevelopmentProcedureshallbeestablished,carriedoutandimprovedtoensuretheinherentquality,effectiveness,safetyandcustomersatisfactionoftheproduct.設計和開發策劃DesignandDevelopmentPlanning在設計和開發策劃期間,本公司需確定Duringthedesignanddevelopmentplanning,ourcompanyshalldetermine:設計各開發所需的過程和階段;thedesignanddevelopmentstages在設計和開發的各階段進行適當的評審,驗證和確認;thereview,verificationandvalidationthatareappropriatetoeachdesignanddevelopmentstage,and設計和開發的職責與權限;theresponsibilitiesandauthoritiesfordesignanddevelopment.公司需處理好參與設計與開發的不同小組間的工作銜接以確保有效交流及明確分工.Thecompanyshallmanagetheinterfacesbetweendifferentgroupsinvolvedindesignanddevelopmenttoensureeffectivecommunicationandclearassignmentofresponsibility.策劃的結果應根據設計和開發的進展進行適當的更新.Planningoutputshallbeupdated,asappropriate,asthedesignanddevelopmentprogresses.設計和開發輸入Designanddevelopmentinputs需確定與產品要求相關的設計和開發輸入并保存相關記錄,輸入包括:Inputsrelatingtoproductrequirementsshallbedeterminedandrecordsmaintained,Theseshallinclude功能、性能和外觀要求;Functional,performanceandappearancerequirements,適用的法律及法規要求;applicablestatutoryandregulatoryrequirements,以前類似的設計信息;whereapplicable,informationderivedfromprevioussimilardesigns,and設計和開發的其它重要要求.otherrequirementsessentialfordesignanddevelopment.設計和開發輸入的適當性需進行評估.要求需完整,明確且不相互抵觸.Theseinputsshallbereviewedforadequacy.Requirementsshallbecomplete,unambiguousandnotinconflictwitheachother.設計和開發輸出Designanddevelopmentoutputs設計和開發輸出必須以表格的形式提供以便能對應設計和開發輸入進行驗證,此外在分發前必須獲得批準.Theoutputsofdesignanddevelopmentshallbeprovidedinaformthatenablesverificationagainstthedesignanddevelopmentinputandshallbeapprovedpriortorelease.設計和開發輸出須Designanddevelopmentoutputsshall滿足設計和開發輸入的要求;meettheinputrequirementsfordesignanddevelopment,提供正確的采購生產及服務信息;provideappropriateinformationforpurchasing,productionandforserviceprovision,包含或提及產品接受標準;containorreferenceproductacceptancecriteria,and詳述產品基本的安全及正確使用方面的特性.specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.設計和開發評審Designanddevelopmentreview在適當時期,應根據策劃階段已擬定的計劃對設計與開發進行系統的評審.Atsuitablestages,systematicreviewsofdesignanddevelopmentshallbeperformedinaccordancewithplannedarrangements.評估設計和開發結果滿足要求的能力Toevaluatetheabilityoftheresultsofdesignanddevelopmenttomeetrequirements,and識別所有問題并提出必要措施toidentifyanyproblemsandproposenecessaryactions.評審過程的參與者應包括與被評審的設計和開發階段相關的各部門代表,應保存相關的評審結果及必要措施的記錄.Participantsinsuchreviewsshallincluderepresentativesoffunctionsconcernedwiththedesignanddevelopmentstage(s)beingreviewed.Recordsoftheresultofthereviewsandanynecessaryactionsshallbemaintained.設計和開發驗證Designanddevelopmentverification應根據策劃階段已擬定的計劃對設計和開發進行驗證以確保其輸出滿足輸入的要求,應保存設計和開發驗證的結果及必要措施的記錄,以下一種或多種驗證方法均可接受:Verificationshallbeperformedinaccordancewithplannedarrangementstoensurethat
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