ISO 13485-2003 医疗器械.质量管理系统.管理目标的要求

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【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
【原文标准名称】:医疗器械.质量管理系统.管理目标的要求
【标准号】:ISO13485-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:回流;检验;服务设施;工艺管理;手册;质量;架设(施工作业);维修;医疗设备;标准;医疗器械;医疗器械;工业;国际标准;详细规范;卖货商;医疗产品;售后服务;开发;仪器;CE标记;验证;生产;医学科学;质量保证体系;消费者与供货者的关系;采办;装置;设计;装配;文献工作;交货条件;应用;规范;规范(验收);定义;电气工程;质量检查;使用;质量评定系统;质量保证;质量要求;交付
【英文主题词】:After-salesservices;Applications;Auditing;Bearings;CEmarking;Conduits;Consumer-supplierrelations;Corrrections;Customers;Data;Definitions;Delivery;Deliveryconditions;Design;Detailspecification;Developments;Documentations;Editing;Electricalengineering;Erecting(constructionoperation);Establishment;Evaluations;Handbooks;Handling;Industries;Inspection;Installation;Installations;Instruments;Internationalstandards;Maintenance;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Organization;Packages;Planning;Preservation;Preventiveactions;Process;Processmanagement;Procurements;Productdesign;Productplanning;Production;Products;Quality;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityauditing;Qualitycontrol;Qualityimprovement;Qualityrequirements;Responsibility;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalltherequirementsofISO9001(seeAnnexB).2ApplicationAllrequirementsofthisInternationalStandardarespecifictoorganizationsprovidingmedicaldevices,regardlessofthetypeorsizeoftheorganization.Ifregulatoryrequirementspermitexclusionsofdesignanddevelopmentcontrols(see7.3),thiscanbeusedasajustificationfortheirexclusionfromthequalitymanagementsystem.Theseregulationscanprovidealternativearrangementsthataretobeaddressedinthequalitymanagementsystem.ItistheresponsibilityoftheorganizationtoensurethatclaimsofconformitywiththisInternationalStandardreflectexclusionofdesignanddevelopmentcontrols[see4.2.2a)and7.3].Ifanyrequirement(s)inClause7ofthisInternationalStandardis(are)notapplicableduetothenatureofthemedicaldevice(s)forwhichthequalitymanagementsystemisapplied,theorganizationdoesnotneedtoincludesucharequirement(s)initsqualitymanagementsystem[see4.2.2a)].TheprocessesrequiredbythisInternationalStandard,whichareapplicabletothemedicaldevice(s),butwhicharenotperformedbytheorganization,aretheresponsibilityoftheorganizationandareaccountedforintheorganization'squalitymanagementsystem[see4.1a)].InthisInternationalStandardtheterms"ifappropriate"and"whereappropriate"areusedseveraltimes.Whenarequirementisqualifiedbyeitherofthesephrases,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.Arequirementisconsidered"appropriate"ifitisnecessaryinorderfor—theproducttomeetspecifiedrequirements,and/or—theorganizationtocarryoutcorrectiveaction.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:57P;A4
【正文语种】:英语