第4部分质量管理系统 (1)

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1Section4Qualitymanagementsystem第四章质量管理体系4.1Generalrequirements一般要求4.2Documentationrequirements文件要求4.2.1General总则4.2.2Qualitymanual质量手册4.2.3Controlofdocuments文件控制4.2.3.C.1ControlofCustomer-SuppliedDocumentsandData–Theorganizationshallestablishandmaintainadocumentedprocedure(s)tocontrolallcustomer-supplieddocumentsanddata(e.g.,networkarchitecture,topology,capacity,installationterminationassignments,anddatabase)ifthesedocumentsanddatainfluencethedesign,verification,validation,inspectionandtesting,orservicingtheproduct.客户提供文件及数据控制-组织将建立并且维护文件化程序以控制所有客户提供的文件和数据(例如,网络体系结构,布局,容量,安装结束任务及数据库)如果这些文件和数据影响设计,验证,确认,检查及测试,或服务于产品。4.2.4Controlofrecords记录控制2Section5Managementresponsibility第五章-管理职责5.1Managementcommitment管理承诺5.2Customerfocus以顾客为关注焦点5.2.C.1CustomerRelationshipDevelopment–Topmanagementshalldemonstrateactiveinvolvementinestablishingandmaintainingmutually-beneficialrelationshipsbetweentheorganizationanditscustomers.[4]发展顾客关系-最高管理者应积极参与建立并维护组织与顾客之间的相互受益的关系。5.2.C.2CustomerCommunicationProcedures–Theorganizationshallestablishandmaintainadocumentedprocedure(s)forcommunicatingwithselectedcustomers.Thedocumentedprocedure(s)shallinclude:顾客沟通程序-组织应建立并维护文件化的程序以确保与特定顾客之间的沟通。该程序文件应包括:a)astrategyandcriteriaforcustomerselection,选择顾客的策略及标准b)amethodfortheorganizationanditscustomerstosharejointexpectationsandimprovethequalityofproducts,and组织和顾客共同参与策划及提高产品质量的方法,和c)ajointreviewwiththecustomeratdefinedintervalscoveringthestatusofsharedexpectationsandincludingamethodtotracktheresolutionofissues.[4]会同顾客安既定的时间间隔评审期望目标的状况,并且应有可以追踪决定流转的方法。5.2.C.2-NOTE1:Itisrecognizedthatitisnotpossibleforanorganizationtoprovidethesamelevelofcommunicationwithallitscustomers.Thelevelprovidedmaydependontheamountofbusinesswiththecustomer,thehistoryofproblems,customerexpectations,andotherfactors(seeAppendixF,“GuidanceforCommunicationwithCustomers”).注解1:众所周知,组织不可能对所有顾客提供同样级别的沟通。所提供的级别应依据与顾客的生意数量、历史问题、顾客期望值,以及其它因素(参见附录F,“顾客沟通指导”)5.3Qualitypolicy质量方针5.4Planning策划5.4.1Qualityobjectives质量目标5.4.1.C.1QualityObjectives–ObjectivesforqualityshallincludetargetsfortheTL9000measurementsdefinedintheTL9000QualityManagementSystemMeasurementsHandbook.质量目标-质量目标应包括在TL9000质量管理体系计算手册中为TL9000定义的对象。5.4.2Qualitymanagementsystemplanning质量管理体系策划35.4.2.C.1Long-andShort-TermQualityPlanning–Theorganization’squalityplanningactivitiesshallincludelong-andshort-termplanswithgoalsforimprovingqualityandcustomersatisfaction.长期和短期质量策划-组织的质量策划行为应包括以提高质量和顾客满意度为目标的长期策划和短期策划。Performancetothesegoalsshallbemonitoredandreported.Theseplansshalladdress:实现这些目标需要监控和汇报。这些策划应注明:a)cycletime,循环时间b)customerservice,顾客服务c)training,培训d)cost,成本e)deliverycommitments,and交货承诺,等f)productreliability.产品可靠性5.4.2.C.1-NOTE1:TopManagementshoulddemonstratetheiractiveinvolvementinlong-andshort-termqualityplanning.注解1:最高管理者应积极参与到长期和短期质量策划中。5.4.2.C.2CustomerInput–Theorganizationshallimplementmethodsforsolicitingandconsideringcustomerinputforqualityplanningactivities.Theorganizationshouldestablishjointqualityimprovementprogramswithcustomers.[4]顾客输入-组织应将顾客输入纳入质量策划中。组织应会同顾客建立质量改进程序。5.4.2.C.3SupplierInput–Theorganizationshallimplementmethodsforsolicitingandusingsupplierinputforqualityplanningactivities.[4]供应商输入-组织应将供应商输入纳入质量策划中。5.5Responsibility,authorityandcommunication职责、权限与沟通5.5.1Responsibilityandauthority职责和权限5.5.2Managementrepresentative管理者代表5.5.3Internalcommunication内部沟通5.5.3.C.1OrganizationPerformanceFeedback–Theorganizationshallinformemployeesofitsqualityperformanceandthelevelofcustomersatisfaction.[4]组织成绩反馈-组织应通知其员工关于质量成绩以及顾客满意程度。5.6Managementreview管理评审45.6.1General总则5.6.2Reviewinput评审输入5.6.3Reviewoutput评审输出5Section6Resourcemanagement第六章资源管理6.1Provisionofresources资源提供6.2Humanresources人力资源6.2.1General总则6.2.2Competence,awarenessandtraining能力、意识和培训6.2.2.C.1InternalCourseDevelopment–Whentheorganizationdevelopsinternaltrainingcourses,itshallestablishandmaintainaprocessforplanning,developing,andimplementingthesecourses.[4]内部课程开展-当组织开展内部培训课程时应当建立并维护一个程序以确保课程的计划、开展及实现。[4]6.2.2.C.2QualityImprovementConcepts–Thoseemployeesthathaveadirectimpactonthequalityoftheproduct,includingtopmanagement,shallbetrainedinthefundamentalconceptsofcontinualimprovement,problemsolving,andcustomersatisfaction.[4]质量改进观念-包括最高管理者在内的所有对产品质量有直接影响的员工应当接受持续改进、解决问题及顾客满意等基本观念的培训。[4]6.2.2.C.3TrainingRequirementsandAwareness–Trainingrequirementsshallbedefinedforallpositionsthathaveadirectimpactonthequalityofproducts.Employeesshallbemadeawareoftrainingopportunities.[4]培训需求和意识-培训需求应针对所有对产品质量有直接影响的职位。员工应该知晓培训的机会。6.2.2.C.4ESDTraining–Allemployeeswithfunctionsthatinvolveanyhandling,storage,packaging,preservation,ordeliveryofESD-sensitiveproductsshallreceivetraininginelectrostaticdischarge(ESD)protectionpriortoperformingtheirjobs.ESD培训-所有包括操作、仓储、包装、保存及运输ESD敏感产品的员工都应接受静电放电培训,以确保他们开展工作。6.2.2.C.5AdvancedQualityTraining–Theorganizationshallofferappropriatelevelsofadvancedqualitytraining.Examplesofadvancedqualitytrainingmayincludestatisticaltechniques,processcapability,statisticalsampling,datacollectionandanalysis,problemidentification,problemanalysis,andcorrectiveandprevent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