【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
【原文标准名称】:医疗设备.质量管理体系.管理要求
【标准号】:BSENISO13485-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-07-24
【实施或试行日期】:2003-07-24
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗器械;仪器;检验;设计;交货条件;医学科学;质量保证;装置;架设(施工作业);使用;质量检查;医疗设备;交付;质量保证体系;质量;CE标记;显影;工业;医疗装置;质量要求;规范(验收);装配;应用;定义;电气工程;消费者与供货者的关系;医疗产品;规范;生产;质量评定系统;验证;售后服务
【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】:ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalltherequirementsofISO9001.AllrequirementsofISO13485:2003arespecifictoorganizationsprovidingmedicaldevices,regardlessofthetypeorsizeoftheorganization.Ifregulatoryrequirementspermitexclusionsofdesignanddevelopmentcontrols,thiscanbeusedasajustificationfortheirexclusionfromthequalitymanagementsystem.Theseregulationscanprovidealternativearrangementsthataretobeaddressedinthequalitymanagementsystem.ItistheresponsibilityoftheorganizationtoensurethatclaimsofconformitywithISO13485:2003reflectexclusionofdesignanddevelopmentcontrols.Ifanyrequirement(s)inClause7ofISO13485:2003is(are)notapplicableduetothenatureofthemedicaldevice(s)forwhichthequalitymanagementsystemisapplied,theorganizationdoesnotneedtoincludesucharequirement(s)initsqualitymanagementsystem.TheprocessesrequiredbyISO13485:2003,whichareapplicabletothemedicaldevice(s),butwhicharenotperformedbytheorganization,aretheresponsibilityoftheorganizationandareaccountedforintheorganization'squalitymanagementsystem.
【中国标准分类号】:C30
【国际标准分类号】:03_120_10;11_040_01
【页数】:72P.;A4
【正文语种】:英语