ISO13485-2003版与ISO13485-1996及ISO9001-2008条款对照

ISO 13485:2003 与 ISO13485:1996 及 ISO 9001 2008 条款对照ISO 9001-2008EN ISO 13485:2012/ISO 13485:2003EN ISO 13485:2003/ ISO 13485:1996Contents 目录Contents 附录Foreword 前言Foreword 前言0 Introduction 弓I言0 Introduction 弓I言0.1 General 总则0.1 General 总则0.2 Process approach 过程方法0.2 Process approach 过程方法0.3 Relationship with ISO 9004与 ISO9004的关 系0.3 Relationship with other standards 与其他标 准的关系0.3.1 Relationship with ISO 9001:2000 与 ISO 9001:2000的关系0.3.2 Relationship with ISO/TR 14969 与 ISO/TR 14969 的关系0.4 Compatibility with other man ageme nt systems与其他管理体系的兼容性（相容性）0.4 Compatibility with other man ageme nt systems与其他管理体系的兼容性Quality man ageme nt systems-Requireme nts 质 量管理体系要求Medical devices Quality man ageme nt systems Requireme nts for regulatory purposes 医疗器械质量管理体系一用于监管目的的要求1 Scope范围1 Scope范围1 Scope范围1.1 General 总则1.1 General 总则1.2 Application 应用1.2 Application 应用2 Normative refere nces规范性引用文件2 Normative refere nces规范性引用文件2 Normative refere nces规范性引用文件3 Terms and defi niti ons 术语和定义3 Terms and defi niti ons 术语和定义3 Definitions 定义4 Quality man ageme nt system 质量管理体系4 Quality man ageme nt system 质量管理体系4 Quality system requirements title only 质量 管理要求4.1 General requirements 总要求4.1 General requirements 总要求4.2.1 General 总要求4.2 Quality system title only质量体系4.2 Documentation requirements 文件要求4.2 Documentation requirements 文件要求4.2.1 General 总则4.2.1 General 总则4.2.2 Quality system procedures 质量体系程序4.2.2 Guality manual 质量手册4.2.2 Guality manual 质量手册4.2.3 Control of documents 文件控制4.2.3 Control of documents 文件控制4.5 Document and data control title only 文件 和数据控制4.5.1 General 总则4.5.2 Docume nt and data approval and issue 文 件和数据批准与发布4.5.3 Docume nt and data cha nges 文件变更4.2.4 Control of records 记录控制4.2.4 Control of records 记录控制4.16 Control of quality records 质量记录控制5 Management responsibility 管理职责5 Management responsibility 管理职责4.1 Management responsibility title only管 理职责5.1 Man ageme nt commitme nt 管理承 诺5.1 Man ageme nt commitme nt 管理承 诺5.2 Customer focus以顾客为关注焦点5.2 Customer focus以顾客为关注焦点5.3 Quality policy 质量方针5.3 Quality policy 质量方针4.1.1 Quality policy 质量方针5.4 Pla nning 策划5.4 Pla nning 策划5.4.1 Quality objectives 质量目标5.4.1 Quality objectives 质量目标5.4.2 Quality Management system Planning 质 量管理体系策划5.4.2 Quality Management system Planning 质 量管理体系策划4.2.3 Quality planning 质量策划5.5 Resp on sibility, authority and com muni cati on 职责、权限与沟通5.5 Resp on sibility, authority and com muni cati on 职责、权限与沟通5.5.1 Responsibility and authority 职责和权限5.5.1 Responsibility and authority 职责和权限5.5.2 Man ageme nt represe ntative 管理者代表5.5.2 Man ageme nt represe ntative 管理者代表5.5.3 Internal com muni cati on 内部沟通5.5.3 Internal com muni cati on 内部沟通5.6 Man ageme nt review 管理评审5.6 Man ageme nt review 管理评审5.6.1 Gen eral 总贝 U5.6.1 Gen eral 总贝 U5.6.2 Review in put 评审输入5.6.2 Review in put 评审输入5.6.3 Review output 评审输 出5.6.3 Review output 评审输 出6 Resource man ageme n资源管理6 Resource man ageme n资源管理4.1.2.2 Resources 资源6.1 Provision of resources 资源提供6.1 Provision of resources 资源提供6.2 Huma n resources 人力资源6.2 Huma n resources 人力资源6.2.1 Gen eral 总则6.2.1 Gen eral 总贝 U6.2.2 Compete nee, trai ning and aware ness 能 力、培训和意识6.2.2 Compete nee, trai ning and aware ness 能 力、培训和意识4.18 Training 培训6.3 Infrastructure 基础设施6.3 Infrastructure 基础设施4.9 Process control 过程控制4.19 Servicing 维修6.4 Work environment 工作环境6.4 Work environment 工作环境4.9 Process control 过程控制7 Product realization 产品实现7 Product realization 产品实现7.1 Planning of product realization 产品实现的 策划7.1 Planning of product realization 产品实现的 策划7.2 Customer-related processes 与顾客有关的 过程7.2 Customer-related processes 与顾客有关的 过程7.2.1 Determ in ati on of requireme nts related to the product与产品有关的要求的确定7.2.1 Determ in ati on of requireme nts related to the product与产品有关的要求的确定7.2.2 Review of requirements related to the product与产品有关的要求的评审7.2.2 Review of requirements related to the product与产品有关的要求的评审4.3 Contract review title only合同评审4.3.1 General title only总则4.3.2 Review 评审4.3.3 Amendment to a contract 合同变更4.3.4 Records 记录7.2.3 Customer com muni cati on 顾客沟通7.2.3 Customer com muni cati on 顾客沟通7.3 Desig n and developme nt 设计和开发7.3 Desig n and developme nt 设计和开发4.4 Design control title only设计控制4.4.1 Ge neral title on ly总则7.3.1 Design and development Planning设计和 开发策划7.3.1 Design and development Planning设计和 开发策划4.4.2 Design and development planning 设计和 开发策划4.4.3 Orga ni zati onal and tech ni cal in terfaces 组 织和技术接口7.3.2 Desi gn and developme nt in puts 设计和开7.3.2 Desi gn and developme nt in puts 设计和开4.4.4 Desi gn in put 设计输入发输入发输入733 Design and development outputs 设计和 开发输出7.3.3 Design and development outputs 设计和 开发输出4.4.5 Design output 设计输出7.3.4 Design and development Reviev设计和开 发评审7.3.4 Design and development Review设计和开 发评审4.4.6 Desig n review 设计评审7.3.5 Design and development verification 设计 和开发验证7.3.5 Design and development verification 设计 和开发验证4.4.7 Design verification 设计验证7.3.6 Design and development validation设计和 开发确认7.3.6 Design and development validation计和 开发确认4.4.8 Design validation 设计确认7.3.7 Control of Design and developmentchan ges设计和开发更改的控制7.3.7 Control of Design and development cha nges设计和开发更改的控制4.4.9 Desig n cha nges 设计变更7.4 Purchasi ng 采购7.4 Purchasi ng 采购4.6 Purchasing title only采购4.6.1 General title only总则7.4.1 Purchasi ng process 采购过程7.4.1 Purchasi ng process 采购过程4.6.2 Evaluation of subcontractors 分承包商评 价7.4.2 Purchasi ng In formation 采购信息7.4.2 Purchasi ng In formation 采购信息4.6.3 Purchasi ng data 采购数据7.4.3 Verification of purchased product 米购产 品的验证7.4.3 Verification of purchased product 米购产 品的验证4.6.4 Verification of purchased product 米购产 品的验证4.10.2 Receiving inspection and testing 进货检 验7.5 Production and service provision 生产和服 务提供7.5 Production and service provision 生产和服 务提供4.15Han dli ng,storage,packag ing,preservation & delivery title only 处理、储存、 包装、防护与交付7.5.1 Con trol product ion and service provisi on 生产和服务提供的控制7.5.1 Control of production and service provision生产和服务提供的控制7.5.1.1 General requirements 总要求7.5.1.2 Control of production and service provisi on . Specific requireme nts 生产和服务 提供的控制一一规定要求4.9 Process control 过程控制4.15.6 Delivery 交付7.5.1.2.1 Clea nli nessof product andcontamination control产品的清洁和污染的控 制7.5.1.2.2 In stallation activities 安装活动7.5.1.2.3 Servicing activities 服务活动7.5.1.3 Particular requirements for sterile medical devices无困医疗器械的专用要求7.5.2 Validati on of processes for product ion and service provision生产和服务提供过程的控制7.5.2 Validati on of processes for product ion and service provision生产和服务提供过程的确认7.5.2.1 Gen eral requireme nts 总要求7.5.2.2 Particular requirements for sterile medical devices无困医疗器械的专用要求4.9 Process control 过程控制7.5.3 Identification and traceability 标识和可追 溯性7.5.3 Identification and traceability 标识和可 追溯性7.5.3.1 Identification 标识7.5.3.2 Traceability 可追溯性7.5.3.2.1 General 总贝U7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices有源植入性医疗器械和植入性医疗器械的专用要求7.5.3.3 Status identification 状态标识4.8 Product identification and traceability 产品 标识与可追溯性7.5.4 Customer property 顾客财产7.5.4 Customer property 顾客财产4.7 Control of customer-supplied product 顾客 提供产品的控制7.5.5 Preservation of product 产品防护7.5.5 Preservation of product 产品防护4.15.1 Ge neral 总则4.15.2 Han dli ng 处理4.15.3 Storage 储存4.15.4 Packagi ng 包装4.15.5 Preservation 防护7.6 Control of monitoring and measuring equipment监视和测量设备的控制7.6 Control of monitoring and measuring devices监视和测量设备的控制4.11 Con trol of in specti on, measuri ng and test equipment title only检杳、测量和试验装置的 控制4.11.1 Ge neral 总则4.11.2 Control procedure 控制程序8 Measurement, analysis and improvement 测 量、分析和改进8 Measurement, analysis and improvement 测 量、分析和改进8.1 General 总则8.1 General 总则4.20.1 Identification of need 需求识别4.20.2 Procedures 程序8.2 Monitoring and measurement 监视和测量8.2 Monitoring and measurement 监视和测量8.2.1 Customer satisfaction 顾客满意8.2.1 Feedback 反馈8.2.2 Internal audit 内部审核8.2.2 Internal audit 内部审核4.17 Internal quality audits 内部质量审核8.2.3 Mon itori ng and measureme nt of processes 过程的监视和测量8.2.3 Mon itori ng and measureme nt of processes 过程的监视和测量8.2.4 Monitoring and measurement of product 产品的监视和测量8.2.4 Monitoring and measurement of product 产品的监视和测量8.2.4.1 General requirements 总要求8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices有源植入性医疗器械和植入性医疗器械的专用要求4.10 Inspection and testing title only检验与试 验4.10.1 General 总则4.10.3 In-process in spect ion and test ing 工序 检验与试验4.10.4 Final in spect ion and test ing 最终产品检 验与试验4.10.5 Inspection and test records 检验与试验 记录8.3 Control of nonconforming product 不合格 品控制8.3 Control of nonconforming product 不合格 品控制4.13 Control of nonconforming product title on ly不合格品控制4.13.1 Ge neral 总则4.13.2 Review and dispositi on of nonconforming product不合格品的评审与处置8.4 Analysis of data 数据分析8.4 Analysis of data 数据分析4.20 Statistical techniques title only统计技术8.5 Improveme nt 改进8.5 Improveme nt 改进4.14 Corrective and preventive action title on ly纠正和预防措施8.5.1 Continual improvement 持续改进8.5.1 Gen eral 总贝 U4.14.1 General 总则8.5.2 Corrective action 纠正措施8.5.2 Corrective action 纠正措施4.14.2 Corrective action 纠正措施8.5.3 Preventive action 预防措施8.5.3 Preventive action 预防措施4.14.3 Preventive action 预防措施Annex A (in formative) Corresp ondence betwee n ISO 9001:2008 and ISO 14001:2004 附录 A 资 料性附录)ISO9001:2008 与 014001:2004之 间的对照Annex A (in formative) Corresp ondence betwee n ISO 13485:2003 and ISO 13485:1996付录 A 资 料性附录)ISO13485:2003与 ISO13485:1996之 间的对照Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 附录 B 资料性 附录)ISO9001:2000与 ISO9001:2008之 间的变 化Annex B (i nformative) Expla nati on of differe nces between ISO 13485:2003 and ISO 9001:2000付 录 B (资料性附录)ISO13485:2003与 ISO9001:2000两者之间的差异说明Bibliography参考文献Bibliography参考文献