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首页 医疗器械质量手册(英文原版)

医疗器械质量手册(英文原版).doc

医疗器械质量手册(英文原版)

huyushan
2013-03-07 0人阅读 举报 0 0 暂无简介

简介:本文档为《医疗器械质量手册(英文原版)doc》,可适用于自然科学领域

MedicalDeviceQualitySystemsManual医疗器械质量体系手册翻译人:胡宇山QQ:EMAIL:huyushanyahoocomcn本资料为个人在工作之余翻译完成只完成了主要内容的翻译由于个人的英文的水平有限还请同行的老师给与提出指正共同学习进步。谢谢!ASmallEntityComplianceGuideFirstEdition(SupersedestheMedicalDeviceGoodManufacturingPracticesGMPManual) 小企业符合法规指南第一版(补充医疗器械良好生产规范手册)ThispageprovidesinformationandaccesstothisCDRHmanualasindividualchaptersasshownbelow:以下部分为CDRH手册各章节内容信息:Chapters章节·Coverpage,Preface,ForewordMedicalDeviceQualitySystemsManual  ·封面引导语序医疗器械质量体系手册·TableofContentsMedicalDeviceQualitySystemsManual  ·目录表医疗器械质量体系手册·TheQualitySystemRegulation  ·质量体系规范·QualitySystems  ·质量体系·DesignControls  ·设计质量控制·ProcessValidation  ·工艺验证·PersonnelandTraining  ·人员和培训·BuildingsandEnvironment  ·厂房和环境·EquipmentandCalibration  ·设备和校验·DeviceMasterRecord  ·产品主记录·DocumentandChangeControl  ·文件和变更控制·PurchasingandAcceptanceActivities  ·采购和接收活动·Labeling  ·标签或标识·ProductEvaluation  ·产品评价·Packaging  ·包装·Storage,DistributionandInstallation  ·产品储存分销运输和安装·Complaints  ·客诉或抱怨·Servicing  ·器械服务或设备维护·QualitySystemsAudits  ·质量体系审核·FactoryInspections  ·现场检查·Appendices  ·补充附件Coverpage,Preface,ForewordMedicalDeviceQualitySystemsManual封面引导语序医疗器械质量体系手册HHSPublicationFDA卫生和社会服务保障部出版FDAMEDICALDEVICEQUALITYSYSTEMSMANUAL:ASMALLENTITYCOMPLIANCEGUIDE医疗器械质量体系手册:小企业法规之南FirstEdition第一版(SupersedestheMedicalDeviceGoodManufacturingPracticesManual)AndrewLowery,JudyStrojny,andJosephPuleoDivisionofSmallManufacturersAssistanceOfficeofHealthandIndustryPrograms(补充医疗器械良好生产规范手册)AndrewLowery,JudyStrojny和JosephPuleo卫生和行业规划项目辅助办公室小型企业部CENTERFORDEVICESANDRADIOLOGICALHEALTHCDRHCDRH器械和放射健康中心December年月(ThispublicationsupersedesFDA)(FDA增补出版)USDEPARTMENTOFHEALTHANDHUMANSERVICES美国健康和社会服务保障部PublicHealthServiceFoodandDrugAdministrationCenterforDevicesandRadiologicalHealthRockville,Maryland食品药品监督管理局公共健康服务器械和放射健康中心马里兰州瑞克维拉号FOREWORD序TheCenterforDevicesandRadiologicalHealth(CDRH)oftheFoodandDrugAdministration(FDA),developsandimplementsnationalprogramstoprotectthepublichealthinthefieldsofmedicaldevicesandradiologicalhealthTheseprogramsareintendedtoassurethesafety,effectiveness,andproperlabelingofmedicaldevices,tocontrolunnecessaryhumanexposuretopotentiallyhazardousionizingandnonionizingradiation,andtoassurethesafe,efficacioususeofsuchradiation食品药品监督管理局(简称FDA)医疗器械和放射健康中心(简称CDRH)在全美范围内开发实施医疗器械和放射性健康领域的全国项目来保护公众健康。这些项目的目的是确保医疗器械的安全性有效性以及医疗器械的适当标识控制人类不必要的暴露在潜在的离子化或者非离子化的射线污染危害同时确保使用这些放射性物质的安全性和有效性。TheCenterpublishestheresultsofitsworkinscientificjournalsandinitsowntechnicalreportsThesereportsdisseminateresultsofCDRHandcontractorprojectsTheyaresoldbytheGovernmentPrintingOfficeandortheNationalTechnicalInformationServiceManyareavailableviatheFDAhomepageontheWorldWideWebat:http:wwwfdagov该中心在科学杂志和他们自己的学术报告中出版发表他们的工作成果。这些报告宣传CDRH研究成果以及协议项目。它们通过政府出版办公室和或者国家技术信息服务部门销售。更多信息可以通过FDA主页http:wwwfdagov获取。WewelcomeyourcommentsandrequestsforfurtherinformationDBruceBurlington,MDDirectorCenterforDevicesandRadiologicalHealthDBruceBurlington博士主编医疗器械和放射健康中心PREFACE引语TheMedicalDeviceAmendmentsofmandatedtheestablishmentof"anidentifiableofficetoprovidetechnicalandothernonfinancialassistancetosmallmanufacturersofmedicaldevicestoassistthemincomplyingwiththerequirementsoftheFederalFood,Drug,andCosmeticAct"TheDivisionofSmallManufacturersAssistance(DSMA)intheOfficeofCommunication,Education,andRadiationPrograms(OCER)wasestablishedtomeetthisrequirementDSMAdevelopseducationalmaterialsandsponsorsworkshopsandconferencestoprovidefirmswithafirsthandworkingknowledgeofmedicaldevicerequirementsandcompliancepolicies年的医疗器械修正案推行建立了“一个为小型企业提供技术和其他非金融援助来帮助它们达到联邦食品、药品、和化妆品法案的要求的独立办公室”。在交通教育和放射性项目办公室(简称OCER)建立小型企业援助部门(简称DSMA)以满足该要求。DSMA编写学习资料和主办学习班和研讨会为企业提供医疗器械要求和法规政策的第一手的实用知识。ThismanualcoverstheQualitySystemregulationandthebasicGoodManufacturingPractices(GMP)requirementsthatallmanufacturersanddistributorsmustconsiderwhentheyplantomanufacturemedicaldevices,includingmedicaldevicekits,traysorpacks,fordistributionintheUnitedStatesModelproceduresandsampleformsarealsoincludedinthemanualtoassistmanufacturers本手册包含质量体系法规和良好生产规范(GMP)的基本要求是在所有的制造商和销售商计划在美国境内生产医疗器械:包含医疗器械套件、托盘或者包装用于在美国境内销售的时候所有的制造商和销售商必须要考虑到的。本手册中还包含典型的程序和示例表单以给予制造商以帮助。AdherencetothemedicaldeviceQualitySystemregulationmakesgoodbusinesssenseandalsoservespublichealthaimstwoverygoodreasonsfortheFoodandDrugAdministration(FDA)toencouragecomplianceHowever,aprerequisitetocomplyingwitharegulationisaclearunderstandingofitscontentRecognizingthisfact,theDivisionofSmallManufacturersAssistance(DSMA)developedthismanualtohelpmanufacturersincreasetheirknowledgeofmedicaldeviceGMPrequirementsandFDAcompliancepoliciesDSMAalsousesthismanualatqualitysystemworkshopsconductedthroughoutthecountry遵守医疗器械质量体系法规营造良好的商业意识同时为公众卫生健康服务是食品药品监督管理局(FDA)鼓励遵守的两个原因所在。但是遵守法规的先决条件是要清楚的领会其内容。基于此小型企业援助部门(DSMA)编写本手册来帮助企业提升它们对医疗器械GMP要求和FDA法规方面的知识水平。DSMA也利用本手册在全国的质量体系学习班或者研讨会作为指导。TheQualitySystemregulationoutlinestheminimumelementsofasystemfordesigningandproducingamedicaldeviceManufacturersofmedicaldevicescommonlyfindthattheirqualityneedsarebroaderthanthesebasicelementsbecauseoftheadditionalneedtomeetcompanyqualityclaimsasrequiredbyparagraph(c)oftheFederalFood,Drug,andCosmetic(FDC)Actandtomeetcustomerneedsandrequirements质量体系规范扼要的介绍体系在设计和生产医疗器械的基本要素。医疗器械制造商通常会发现它们的质量需求远多于这些基本要素因为额外的质量需求以满足联邦食品、药品、和化妆品(FDC)法案第(c)条要求的公司质量承诺同时满足客户需要和要求。TheDSMAstaffandtheOfficeofCompliance(OC)intheCenterforDevicesandRadiologicalHealth(CDRH)providedvaluableassistanceinpreparingthismanualDSMA人员和医疗器械和放射健康中心(CDRH)法规办公室(OC)在编写该手册时给予了极大帮助。Forfurtherinformation,contacttheappropriateofficewithinCDRHorcallDSMAat,orFAXCommentsonthismanual,relatedworkshops,andotherDSMAactivitiesarealwayswelcome欲获取更多信息请与CDRH对应办公室联系或者电话咨询DSMA,或者传真咨询。欢迎对本手册相关的学习班或者研讨会以及其他的DSMA活动提出意见和建议。LirekaPJoseph,DrPHDirectorOfficeofHealthandIndustryProgramsLirekaPJoseph,DrPH理事卫生与行业开发项目办公室NOTETOMANUFACTURERSOFMEDICALDEVICES给予医疗器械制造商的提示TheQualitySystem(QS)regulationindicatestherequiredendresultratherthanspecificallyprescribinghowamanufactureristocomplywiththisregulationItistheresponsibilityofthemanufacturertousegoodjudgmentwhendevelopingaqualitysystemwhichappropriatelyappliestheQSregulationtotheirspecificproductsandoperationsThemanufacturer,notFDA,bearsoverallresponsibilityfortheproductionofhighqualityproducts质量体系(QS)规范只是提出必须的最终要求而不是具体规定制造商如何去遵守该规范。在针对它们的特定产品或者操作开发建立QS规范时作出正确的选择是制造商的责任。制造商而不是FDA对生产出合格产品负全责。Nevertheless,FDArecognizesthatmanufacturersmaybenefitfromhavingguidance,modelprocedures,andsampleformsthatothershavedevelopedoradoptedinanefforttocomplywiththeintentoftheregulationTheguidanceinthismanualincludesdiscussionontheentireQSregulation,plusitprovidesmultipleexamplesofproceduresandformswhichcanbeadoptedandmodifiedbymanufacturersasappropriate当然FDA认识到制造商可以从其他为了符合法规内容而编写开发的现有的指南典型程序和示例表单获益。本手册中的指南包含关于这个QS法规的讨论加上其提供的许多示例程序和表单制造商可以采用或者适当优化。WehaveincludedavarietyofmodelproceduresandsampleformsinthismanualHowever,thesearenotmeanttobeofficialstatementsofFDApolicyRather,theyrepresentacompilationofexamplesthatfirmsmayfindusefulinunderstandinghowsomemanufacturershavesuccessfullycompliedwithQSandorGMPrequirementsBeforeanymodelprocedureorformisadoptedintoaqualitysystemprogram,theapplicabilityandsuitabilitytoaparticulardeviceandmanufacturingoperationshouldbecarefullyexaminedThismanualwillassistyouindevelopingaqualitysystemthatmeetstheintentoftheFDAQualitySystemregulation我们在本手册中收集了大量的典型程序和示例表单。但是这些并不意味着是FDA法规中的正式标准描述。而是他们代表了企业在理解一些制造商如何成功满足QS或者GMP要求的做法可以得到有益的帮助。在典型程序或者表单采纳到质量体系项目中之前需要仔细检查其针对特定产品和制造操作的适用性和匹配性。本手册将会在编写开发建立质量体系以满足FDA质量体系法规内容方面给予帮助。FDAalsorecognizesthecontinuingneedtouseinnovativeapproaches,particularlyindealingwithsmallbusinessesthatcouldbeunnecessarilyadverselyaffectedbyfederalregulationsItishopedthattheinformationinthismanualwillassistmanufacturersintheireffortstoestablishandmaintainaqualitysystemthatenhancesbusinessTheOfficeofComplianceatorDSMAat,FAX,canbecontactedforadditionalassistanceandinformationFDA也认识到需要持续运用创新方法特别是在处理一些在本手册中认为可有可无的信息细小事务以帮助企业努力建立和维护质量体系以提升业务量。法规办公室电话:或者DSMA,传真来咨询更多信息和更多帮助。ThismanualcanbepurchasedfromtheSuperintendentofDocuments,USGovernmentPrintingOffice,WashingtonDC,telephone,andfromtheNationalTechnicalInformationService,USDepartmentofCommerce,PortRoyalRoad,Springfield,VA,telephoneThismanualisalsoavailabletoallmanufacturersthroughtheWorldWideWebat:http:wwwfdagov本手册可以通过美国政府印刷出版办公室文件高级主管购买华盛顿特区电话以及美国商务部全国技术信息服务部门美国弗吉尼亚州Springfield港口皇家路电话全世界的制造商可以通过http:wwwfdagov获得。Sincerelyyours,JohnFStigiDirectorDivisionofSmallManufacturersAssistance挚友JohnFStigi理事小型企业援助部门ABSTRACT摘要ALowery,JStrojny,andJPuleo,ProjectOfficersDivisionofSmallManufacturersAssistance,OfficeofHealthandIndustryProgramsMedicalDeviceQualitySystemsManual:ASmallEntityComplianceGuideHHSPublicationFDA(December)卫生与行业项目办公室小企业援助部门项目人员ALowery,JStrojny,andJPuleo。医疗器械质量体系手册:小企业法规指南。健康与社会服务部出版FDA(年月)ThismanualcoversrequirementsoftheQualitySystemregulationthatmanufacturersofmedicaldevicesmustconsiderwhentheydesigndevices,orwhentheymanufacture,contractmanufacture,remanufacture,process,repack,orrelabelfinishedmedicaldevicesintendedtobecommerciallydistributedThemanualcontainsarticlesthatexplainthevariousgoodmanufacturingpractices(GMP)requirementssuchasdesigncontrols,processvalidation,calibration,devicemasterrecords,componentcontrol,etc,alongwithrelatedtopicssuchaslabelingItalsocontainsexamplesofforms,procedures,decals,etcManufacturersmayusethisguidancewhendevelopingtheirqualitysystem本手册包含了医疗器械制造商在器械产品设计或者生产制造协议制造改造加工改装或者在医疗器械商业销售最终确认时必须要考虑的质量体系法规的要求。本手册包含解释各种GMP要求的段落比如设计控制工艺验证校验产品主文件部件控制等以及标识等相关问题。也包括表单程序标识等示例。制造商可以在编写开发它们质量体系时适用该指南。ThismanualincorporateschangesrequiredbytheSafeMedicalDevicesActofandtheMedicalDeviceAmendmentsofThismanualisanupdateofHHSpublicationFDA,"MedicalDeviceGoodManufacturingPracticesManual,FifthEdition"本手册根据年的医疗器械安全法案和年医疗器械修正案合并变更。本手册是HHS出版FDA的更新版本。“医疗器械良好生产规范手册第五版”ThismanualisusedintheDivisionofSmallManufacturersAssistance(DSMA)medicaldeviceworkshops本手册用于小型企业援助部门医疗器械学习班或者研修班。Thementionofcommercialproducts,theirsources,ortheiruseinconnectionwithmaterialreportedhereinisnottobeconstruedaseitheranactualorimpliedendorsementofsuchproductsbytheDepartmentTheeducationalinformationinthismanualisnotanofficialstatementbindingFDA提及的商业产品它们的来源或者在此提到的相关材料并不意味着相关部门推荐或者暗示支持相关产品。本手册中的教育信息不是FDA官方约束正式态度。AlthoughthisguidancedocumentdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic,itdoesrepresenttheagency'scurrentthinkingonguidanceforqualitysystems虽然本指南文件没有创建或者授权给任何人也没有FDA或者官方约束但是它代表机构关于质量体系指南的主流观点。Wherethisdocumentreiteratesarequirementimposedbystatuteorregulation,theforceandeffectaslawoftherequirementisnotchangedinanywaybyvirtueofitsinclusioninthisdocument本文件重申法规或者规范的要求法律要求的效力依据本文件中的内容没有任何形式的变化。TableofContentsMedicalDeviceQualitySystemsManual目录表医疗器械质量体系手册Coverpage,Preface,Foreword封面前言序TheQualitySystemRegulationAnIntroduction质量体系规范简介QualitySystems质量体系DesignControls设计控制ProcessValidation工艺验证Personnel人员BuildingsandEnvironment厂房和环境EquipmentandCalibration设备和校验DeviceMasterRecord产品主记录DocumentandChangeControl文件和变更控制PurchasingandAcceptanceActivities采购和接受活动Labeling标识与标签ProductEvaluation产品评价和评估Packaging包装Storage,Distribution,andInstallation储存、运输和安装Complaints客诉或者抱怨Servicing服务及维护QualitySystemsAudits质量体系审核FactoryInspections现场检查Appendix(IndexofAppendices)附录(附录索引)TheQualitySystemRegulation质量体系规范INTRODUCTION简介FLEXIBILITYOFTHEGMPGMP的灵活性MANUALCONTENTS手册内容GMPAPPLICATIONSANDEXEMPTIONSGMP适用和豁免     Exemptions豁免     ComponentManufacturers部件制造商     Remanufacturers改制或者改造商     CustomDeviceManufacturers定制器械制造商     ContractManufacturers协议制造商     ContractTesting协议测试     Repackagers,Relabelers,andSpecificationDevelopers改包装重新确认和规格开发商     InitialDistributorsofImportedDevices进口器械初始分销商INTRODUCTION简介ThecurrentGoodManufacturingPractices(GMP)requirementssetforthintheQualitySystem(QS)regulationarepromulgatedundersectionoftheFood,DrugandCosmetic(FDC)ActTheyrequirethatdomesticorforeignmanufacturershaveaqualitysystemforthedesignandproductionofmedicaldevicesintendedforcommercialdistributionintheUnitedStatesTheregulationrequiresthatvariousspecificationsandcontrolsbeestablishedfordevicesthatdevicesbedesignedunderaqualitysystemtomeetthesespecificationsthatdevicesbemanufacturedunderaqualitysystemthatfinisheddevicesmeetthesespecificationsthatdevicesbecorrectlyinstalled,checkedandservicedthatqualitydatabeanalyzedtoidentifyandcorrectqualityproblemsandthatcomplaintsbeprocessedThus,theQSregulationhelpsassurethatmedicaldevicesaresafeandeffectivefortheirintendeduseTheFoodandDrugAdministration(FDA)monitorsdeviceproblemdataandinspectstheoperationsandrecordsofdevicedevelopersandmanufacturerstodeterminecompliancewiththeGMPrequirementsintheQSregulation质量体系(QS)规范中所述的现行良好生产规范(GMP)要求发布在食品、药品和化妆品(FDC)法案中。它们要求国内外的制造商对于医疗器械的设计和生产要建立质量体系方可以在美国商业销售。法规要求针对产品建立各种标准和控制方法产品设计按照质量体系要求以满足这些标准在质量体系规范下生产制造器械产品最终成品满足这些标准器械产品正确安装检查和服务保障分析质量数据资料以发现并纠正质量问题处理客诉。因此QS规范帮助确保医疗器械在使用中的安全性和有效性。食品药品监督管理局(FDA)监督器械的问题数据检查操作过程器械开发商和制造商的记录来判断是否符合QS法规中的GMP要求。TheQSregulationisinPartofTitleoftheCodeofFederalRegulations(CFR)Thisregulationcoversqualitymanagementandorganization,devicedesign,buildings,equipment,purchaseandhandlingofcomponents,productionandprocesscontrols,packagingandlabelingcontrol,deviceevaluation,distribution,installation,complainthandling,servicing,andrecordsThepreambledescribesthepubliccommentsreceivedduringthedevelopmentoftheQSregulationanddescribestheFDACommissioner'sresolutionofthecommentsThus,thepreamblecontainsvaluableinsightintothemeaningandintentoftheQSregulation质量体系法规包含在联邦法规准则(CFR)标题的部分。该法规包含质量管理和组织、器械产品设计、厂房、设备、采购和部件加工、生产和工艺控制、包装和标识控制、产品评价、运输、安装、抱怨处理、服务保障、和记录。序言描述了在QS规范编写过程中收到的评价建议以及描述了FDA官员的建议处理措施。因此前言包含了QS法规的方法和意图的宝贵的深刻理解。TheQSregulationisreprintedintheappendixofthismanual 质量体系法规附在本手册的附录中。FLEXIBILITYOFTHEGMPGMP的灵活性ManufacturersshouldusegoodjudgmentwhendevelopingtheirqualitysystemandapplythosesectionsoftheQSregulationthatareapplicabletotheirspecificproductsandoperationsSectionoftheQSregulationrequiresthat,"Eachmanufacturershallestablishandmaintainaqualitysystemthatisappropriateforthespecificdevice(s)designedormanufactured,andthatmeetstherequirementsofthispart"Theword"appropriate"meansthattheruleisaflexibleregulationHowever,ifmanufacturersdecidetonotimplementcertainGMPrequirementswhicharequalifiedbytheterm"whereappropriate,"theyshoulddocumenttheirjustificationfornonimplementationThejustificationshouldshowthatnotimplementingarequirementisnotreasonablyexpectedtoresultinproductthatdoesnotmeetspecificationsorfailuretocarryoutanynecessarycorrectiveaction(a)(Operatingwithinthisflexibility,itistheresponsibilityofeachmanufacturertoestablishrequirementsforeachtypeorfamilyofdevicesthatwillresultindevicesthataresafeandeffective,andtoestablishmethodsandprocedurestodesign,produce,anddistributedevicesthatmeetthequalitysystemrequirementsFDAhasidentifiedintheQSregulationtheessentialelementsthataqualitysystemshallembodyfordesign,productionanddistribution,withoutprescribingspecificwaystoestablishtheseelementsBecausetheQSregulationcoversabroadspectrumofdevicesandproductionprocesses,itallowssomeleewayinthedetailsofqualitysystemelementsItislefttomanufacturerstodeterminethenecessityfor,orextentofsomequalityelementsandtodevelopandimplementspecificprocedurestailoredtotheirparticularprocessesanddevicesForexample,ifitisimpossibletomixuplabelsatamanufacturerbecausethereisonlyonelabeloroneproduct,thenthereisnonecessityforthemanufacturertocomplywithalloftheGMPrequirementsunderdevicelabeling制造商应该在建立他们自己的质量体系作出最佳的判断并运用QS法规中的针对他们特定产品和操作的部分。QS法规中部分要求:“所有制造商均应针对设计制造的适合的特定器械产品建立并持续改进其质量体系以达到这部分的要求。”“适合”意味着该规定是一种具有灵活性的法规。但是如果制造商认为不实施规定中要求的“合适的”特定的GMP要求那么他们必须要能够不实施的理由。该理由应该能够证明不按照该要求执行不会导致产品不合格或者应用失败而需要开展任何手段的纠正措施((a)())。这种操作的灵活性每个制造商均有责任和义务制定对于每种或者每一类别的器械产品建立质量要求以保证切屑设备的安全和有效建立方法和流程来应用于设计、制造和运输器械产品以满足质量体系的要求。FDA在质量体系法规中明确规定了质量体系应该包含设计、生产、和运输环节的基本要素但是没有针对这些要素给出具体的要求。因为质量体系规范包含非常广泛的器械产品种类和生产工艺因此它允许一些质量体系要素的细节方面的灵活性。留给制造商来根据他们自身的特定产品工艺来适当调整必要的或者衍生出一些质量要素开发并实施具有自身特色的程序或者流程。例如:企业只生成一种标签或者只有一种器械产品根本不可能造成标签混淆那么该企业就没有必要遵循GMP关于产品标识的要求。ThemedicaldeviceQSregulationrequiresan"umbrella"qualitysystemintendedtocoverthedesign,production,anddistributionofallmedicaldevicesfromsimplesurgicalhandtoolstoverycomplexcomputerizedaxialtomography(CAT)scannersItisnotpracticalforaregulationtospecifydetailsofqualitysystemelementsforsuchawiderangeofproductsRather,theQSregulationspecifiesgeneralobjectivessuchasuseoftrainedemployees,designreviews,designvalidation,calibratedequipment,processcontrols,etc,ratherthanmethods,becauseaspecificmethodwouldnotbeappropriatetoalloperations医疗器械质量体系法规要求建立“伞状”质量体系目的是覆盖从简单的手术手动工具到非常复杂的CAT扫描仪的所有医疗器械的设计、生产和运输环节。如果要求对拥有如此广泛产品类别的质量体系法规的具体细节要素作出详细的规定是不切实际、不可行的。而应该是质量体系规范规定如雇佣经过培训或者有经验的员工、设计评估、设计评价、设计验证、使用经过校验的仪器设备、过程控制等总的目标要求而不是具体的方法因为一种特定的方法不可能适用于所有的操作。Inmostcases,itislefttothemanufacturertodeterminethebestmethodstoattainqualityobjectivesInsomecases,however,theQSregulationdoesspecifytheparticulartypeofmethodtobeused,suchaswrittenproceduresorwr

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医疗器械质量手册(英文原版)

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