搜索
1SecretariatofISO/TC176/SC2Date:3June2013TotheMembersofISO/TC176/SC2-QualityManagementandQualityAssurance/QualitySystemsISO/CD9001目录1Scope范围2Normativereferences规范性引用文件3Termsanddefinitions术语和定义4Contextoftheorganization组织的背景4.1Understandingtheorganizationanditscontext理解组织及其背景4.2Understandingtheneedsandexpectationsofinterestedparties理解相关方的需求和期望4.3Determiningthescopeofthequalitymanagementsystem质量管理体系范围的确定4.4Qualitymanagementsystem质量管理体系5Leadership领导作用5.1Leadershipandcommitment领导作用和承诺5.2Qualitypolicy质量方针5.3Organizationalroles,responsibilitiesandauthorities组织的作用、职责和权限6Planning策划6.1Actionstoaddressrisksandopportunities风险和机遇的应对措施6.2Qualityobjectivesandplanningtoachievethem质量目标及其实施的策划6.3Planningofchanges变更的策划7Support支持7.1Resources资源7.2Competence能力7.3Awareness意识7.4Communication沟通7.5Documentedinformation形成文件的信息8Operation运行8.1Operationalplanningandcontrol运行的策划和控制8.2Determinationofmarketneedsandinteractionswithcustomers市场需求的确定和顾客沟通8.3Operationalplanningprocess运行策划过程28.4Controlofexternalprovisionofgoodsandservices外部供应产品和服务的控制8.5Developmentofgoodsandservices产品和服务开发8.6Productionofgoodsandprovisionofservices产品生产和服务提供8.7Releaseofgoodsandservices产品和服务放行8.8Nonconforminggoodsandservices不合格产品和服务9Performanceevaluation绩效评价9.1Monitoring,measurement,analysisandevaluation监视、测量、分析和评价9.2InternalAudit内部审核9.3Managementreview管理评审10Continualimprovement持续改进10.1Nonconformityandcorrectiveaction不符合和纠正措施10.2Improvement改进附录AAnnexAQualitymanagementprinciples(Informative)质量管理原则文献1．Scope范围ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization本标准为有下列需求的组织规定了质量管理体系要求：a）needstodemonstrateitsabilitytoconsistentlyprovidegoodsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,and需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；b）aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirements通过体系的的有效应用，包括体系持续改进的过程，以及保证符合顾客和适用的法律法规要求，旨在增强顾客满意。注1：InthisInternationalStandard,theterm“product”onlyappliesto在本标准一中，术语“产品”仅适用于：a)goodsandservicesintendedfor,orrequiredby,acustomer,and预期提供给顾客或顾客所要求的商品和服务；b)anyintendedoutputresultingfromtheoperationalprocesses运行过程所产生的任何预期输出。注2：Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements法律法规要求可称作为法定要求。2Normativereferences规范性引用文件Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies下列文件中的条款通过本标准的引用而构成本标准的条款。凡是注日期的引用文件，只有引用的版本适用。凡是不注日期的引用文件，其最新版本（包括任何修订）适用于本标准。ISO9000:2015,Qualitymanagementsystems—FundamentalsandvocabularyGB/T19000-2015质量管理体系基础和术语33Termanddefinitions术语和定义Forthepurposesofthisdocument,thetermsanddefinitionsgiveninISO9000apply本标准采用GB/T19000中所确立的术语和定义。4Contextoftheorganization组织的背景环境4.1Understandingtheorganizationanditscontext理解组织及其背景环境Theorganizationshalldetermineexternalandinternalissues,thatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedoutcome(s)ofitsqualitymanagementsystem组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事务。Theorganizationshallupdatesuchdeterminationswhenneeded需要时，组织应更新这些信息。Whendeterminingrelevantexternalandinternalissues,theorganizationshallconsiderthosearisingfrom:在确定这些相关的内部和外部事宜时，组织应考虑以下方面：a)changesandtrendswhichcanhaveanimpactontheobjectivesoftheorganization可能对组织的目标造成影响的变更和趋势；b)relationshipswith,andperceptionsandvaluesofrelevantinterestedparties与相关方的关系，以及相关方的理念、价值观；c)governanceissues,strategicpriorities,internalpoliciesandcommitments;and组织管理、战略优先、内部政策和承诺；d)resourceavailabilityandprioritiesandtechnologicalchange资源的获得和优先供给、技术变更。注1：Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,competitive,cultural,social,economicandnaturalenvironment,whetherinternational,national,regionalorlocal.外部的环境，可以考虑法律、技术、竞争、文化、社会、经济和自然环境方面，不管是国际、国家、地区或本地。注2：Whenunderstandingtheinternalcontexttheorganizationcouldconsiderthoserelatedtoperceptions,valuesandcultureoftheorganization.内部环境，可以组织的理念、价值观和文化。4.2Understandingtheneedsandexpectationsofinterestedparties理解相关方的需求和期望Theorganizationshalldetermine组织应确定：a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem,and与质量管理体系有关的相关方b)therequirementsoftheseinterestedparties相关方的要求Theorganizationshallupdatesuchdeterminationsinordertounderstandandanticipateneedsorexpectationsaffectingcustomerrequirementsandcustomersatisfaction组织应更新以上确定的结果，以便于理解和满足影响顾客要求和顾客满意度的需求和期望。Theorganizationshallconsiderthefollowingrelevantinterestedparties组织应考虑以下相关方：a)directcustomers直接顾客4b)endusers最终使用者c)suppliers,distributors,retailersorothersinvolvedinthesupplychain供应链中的供方、分销商、零售商及其他d)regulators;and立法机构e)anyotherrelevantinterestedparties其他注：NoteAddressingcurrentandanticipatedfutureneedscanleadtotheidentificationofimprovementandinnovationopportunities应对当前的和预期的未来需求可导致改进和变革机会的识别。4.3Determiningthescopeofthequalitymanagementsystem确定质量管理体系的范围Theorganiz