ISO13485-2003版與ISO13485-1996及ISO9001-2008條款對照

1、ISO 13485:2003 與 ISO13485:1996 及 ISO 9001 2008 條款對照ISO 9001-2008EN ISO 13485:2012/ISO 13485:2003EN ISO 13485:2003/ ISO 13485:1996Contents 目錄Contents 附錄Foreword 前言Foreword 前言0 Introduction 弓I言0 Introduction 弓I言0.1 General 總則0.1 General 總則0.2 Process approach 過程方法0.2 Process approach 過程方法0.3 Relations

2、hip with ISO 9004與 ISO9004的關(guān) 系0.3 Relationship with other standards 與其他標(biāo) 準(zhǔn)的關(guān)系0.3.1 Relationship with ISO 9001:2000 與 ISO 9001:2000的關(guān)系0.3.2 Relationship with ISO/TR 14969 與 ISO/TR 14969 的關(guān)系0.4 Compatibility with other man ageme nt systems與其他管理體系的兼容性（相容性）0.4 Compatibility with other man ageme nt syste

3、ms與其他管理體系的兼容性Quality man ageme nt systems-Requireme nts 質(zhì) 量管理體系要求Medical devices Quality man ageme nt systems Requireme nts for regulatory purposes 醫(yī)療器械質(zhì)量管理體系一用于監(jiān)管目的的要求1 Scope范圍1 Scope范圍1 Scope范圍1.1 General 總則1.1 General 總則1.2 Application 應(yīng)用1.2 Application 應(yīng)用2 Normative refere nces規(guī)范性引用文件2 Normative

4、 refere nces規(guī)范性引用文件2 Normative refere nces規(guī)范性引用文件3 Terms and defi niti ons 術(shù)語和定義3 Terms and defi niti ons 術(shù)語和定義3 Definitions 定義4 Quality man ageme nt system 質(zhì)量管理體系4 Quality man ageme nt system 質(zhì)量管理體系4 Quality system requirements title only 質(zhì)量 管理要求4.1 General requirements 總要求4.1 General requirements

5、總要求4.2.1 General 總要求4.2 Quality system title only質(zhì)量體系4.2 Documentation requirements 文件要求4.2 Documentation requirements 文件要求4.2.1 General 總則4.2.1 General 總則4.2.2 Quality system procedures 質(zhì)量體系程序4.2.2 Guality manual 質(zhì)量手冊4.2.2 Guality manual 質(zhì)量手冊4.2.3 Control of documents 文件控制4.2.3 Control of documents

6、 文件控制4.5 Document and data control title only 文件 和數(shù)據(jù)控制4.5.1 General 總則4.5.2 Docume nt and data approval and issue 文 件和數(shù)據(jù)批準(zhǔn)與發(fā)布4.5.3 Docume nt and data cha nges 文件變更4.2.4 Control of records 記錄控制4.2.4 Control of records 記錄控制4.16 Control of quality records 質(zhì)量記錄控制5 Management responsibility 管理職責(zé)5 Managem

7、ent responsibility 管理職責(zé)4.1 Management responsibility title only管 理職責(zé)5.1 Man ageme nt commitme nt 管理承 諾5.1 Man ageme nt commitme nt 管理承 諾5.2 Customer focus以顧客為關(guān)注焦點(diǎn)5.2 Customer focus以顧客為關(guān)注焦點(diǎn)5.3 Quality policy 質(zhì)量方針5.3 Quality policy 質(zhì)量方針4.1.1 Quality policy 質(zhì)量方針5.4 Pla nning 策劃5.4 Pla nning 策劃5.4.1 Qua

8、lity objectives 質(zhì)量目標(biāo)5.4.1 Quality objectives 質(zhì)量目標(biāo)5.4.2 Quality Management system Planning 質(zhì) 量管理體系策劃5.4.2 Quality Management system Planning 質(zhì) 量管理體系策劃4.2.3 Quality planning 質(zhì)量策劃5.5 Resp on sibility, authority and com muni cati on 職責(zé)、權(quán)限與溝通5.5 Resp on sibility, authority and com muni cati on 職責(zé)、權(quán)限與溝通5.

9、5.1 Responsibility and authority 職責(zé)和權(quán)限5.5.1 Responsibility and authority 職責(zé)和權(quán)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 內(nèi)部溝通5.5.3 Internal com muni cati on 內(nèi)部溝通5.6 Man ageme nt review 管理評審5.6 Man ageme nt review 管理評審5.6.1 Gen eral

10、 總貝 U5.6.1 Gen eral 總貝 U5.6.2 Review in put 評審輸入5.6.2 Review in put 評審輸入5.6.3 Review output 評審輸 出5.6.3 Review output 評審輸 出6 Resource man ageme n資源管理6 Resource man ageme n資源管理4.1.2.2 Resources 資源6.1 Provision of resources 資源提供6.1 Provision of resources 資源提供6.2 Huma n resources 人力資源6.2 Huma n resource

11、s 人力資源6.2.1 Gen eral 總則6.2.1 Gen eral 總貝 U6.2.2 Compete nee, trai ning and aware ness 能 力、培訓(xùn)和意識6.2.2 Compete nee, trai ning and aware ness 能 力、培訓(xùn)和意識4.18 Training 培訓(xùn)6.3 Infrastructure 基礎(chǔ)設(shè)施6.3 Infrastructure 基礎(chǔ)設(shè)施4.9 Process control 過程控制4.19 Servicing 維修6.4 Work environment 工作環(huán)境6.4 Work environment 工作環(huán)

12、境4.9 Process control 過程控制7 Product realization 產(chǎn)品實現(xiàn)7 Product realization 產(chǎn)品實現(xiàn)7.1 Planning of product realization 產(chǎn)品實現(xiàn)的 策劃7.1 Planning of product realization 產(chǎn)品實現(xiàn)的 策劃7.2 Customer-related processes 與顧客有關(guān)的 過程7.2 Customer-related processes 與顧客有關(guān)的 過程7.2.1 Determ in ati on of requireme nts related to the

13、product與產(chǎn)品有關(guān)的要求的確定7.2.1 Determ in ati on of requireme nts related to the product與產(chǎn)品有關(guān)的要求的確定7.2.2 Review of requirements related to the product與產(chǎn)品有關(guān)的要求的評審7.2.2 Review of requirements related to the product與產(chǎn)品有關(guān)的要求的評審4.3 Contract review title only合同評審4.3.1 General title only總則4.3.2 Review 評審4.3.3 Amen

14、dment to a contract 合同變更4.3.4 Records 記錄7.2.3 Customer com muni cati on 顧客溝通7.2.3 Customer com muni cati on 顧客溝通7.3 Desig n and developme nt 設(shè)計和開發(fā)7.3 Desig n and developme nt 設(shè)計和開發(fā)4.4 Design control title only設(shè)計控制4.4.1 Ge neral title on ly總則7.3.1 Design and development Planning設(shè)計和 開發(fā)策劃7.3.1 Design a

15、nd development Planning設(shè)計和 開發(fā)策劃4.4.2 Design and development planning 設(shè)計和 開發(fā)策劃4.4.3 Orga ni zati onal and tech ni cal in terfaces 組 織和技術(shù)接口7.3.2 Desi gn and developme nt in puts 設(shè)計和開7.3.2 Desi gn and developme nt in puts 設(shè)計和開4.4.4 Desi gn in put 設(shè)計輸入發(fā)輸入發(fā)輸入733 Design and development outputs 設(shè)計和 開發(fā)輸出7.3

16、.3 Design and development outputs 設(shè)計和 開發(fā)輸出4.4.5 Design output 設(shè)計輸出7.3.4 Design and development Reviev設(shè)計和開 發(fā)評審7.3.4 Design and development Review設(shè)計和開 發(fā)評審4.4.6 Desig n review 設(shè)計評審7.3.5 Design and development verification 設(shè)計 和開發(fā)驗證7.3.5 Design and development verification 設(shè)計 和開發(fā)驗證4.4.7 Design verificati

17、on 設(shè)計驗證7.3.6 Design and development validation設(shè)計和 開發(fā)確認(rèn)7.3.6 Design and development validation®計和 開發(fā)確認(rèn)4.4.8 Design validation 設(shè)計確認(rèn)7.3.7 Control of Design and developmentchan ges設(shè)計和開發(fā)更改的控制7.3.7 Control of Design and development cha nges設(shè)計和開發(fā)更改的控制4.4.9 Desig n cha nges 設(shè)計變更7.4 Purchasi ng 采購7.4 Pu

18、rchasi ng 采購4.6 Purchasing title only采購4.6.1 General title only總則7.4.1 Purchasi ng process 采購過程7.4.1 Purchasi ng process 采購過程4.6.2 Evaluation of subcontractors 分承包商評 價7.4.2 Purchasi ng In formation 采購信息7.4.2 Purchasi ng In formation 采購信息4.6.3 Purchasi ng data 采購數(shù)據(jù)7.4.3 Verification of purchased prod

19、uct 米購產(chǎn) 品的驗證7.4.3 Verification of purchased product 米購產(chǎn) 品的驗證4.6.4 Verification of purchased product 米購產(chǎn) 品的驗證4.10.2 Receiving inspection and testing 進(jìn)貨檢 驗7.5 Production and service provision 生產(chǎn)和服 務(wù)提供7.5 Production and service provision 生產(chǎn)和服 務(wù)提供4.15Han dli ng,storage,packag ing,preservation & deli

20、very title only 處理、儲存、 包裝、防護(hù)與交付7.5.1 Con trol product ion and service provisi on 生產(chǎn)和服務(wù)提供的控制7.5.1 Control of production and service provision生產(chǎn)和服務(wù)提供的控制7.5.1.1 General requirements 總要求7.5.1.2 Control of production and service provisi on . Specific requireme nts 生產(chǎn)和服務(wù) 提供的控制一一規(guī)定要求4.9 Process control 過程控

21、制4.15.6 Delivery 交付7.5.1.2.1 Clea nli nessof product andcontamination control產(chǎn)品的清潔和污染的控 制7.5.1.2.2 In stallation activities 安裝活動7.5.1.2.3 Servicing activities 服務(wù)活動7.5.1.3 Particular requirements for sterile medical devices無困醫(yī)療器械的專用要求7.5.2 Validati on of processes for product ion and service provisio

22、n生產(chǎn)和服務(wù)提供過程的控制7.5.2 Validati on of processes for product ion and service provision生產(chǎn)和服務(wù)提供過程的確認(rèn)7.5.2.1 Gen eral requireme nts 總要求7.5.2.2 Particular requirements for sterile medical devices無困醫(yī)療器械的專用要求4.9 Process control 過程控制7.5.3 Identification and traceability 標(biāo)識和可追 溯性7.5.3 Identification and traceabi

23、lity 標(biāo)識和可 追溯性7.5.3.1 Identification 標(biāo)識7.5.3.2 Traceability 可追溯性7.5.3.2.1 General 總貝U7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices有源植入性醫(yī)療器械和植入性醫(yī)療器械的專用要求7.5.3.3 Status identification 狀態(tài)標(biāo)識4.8 Product identification and traceability 產(chǎn)品 標(biāo)識與可追溯性7.

24、5.4 Customer property 顧客財產(chǎn)7.5.4 Customer property 顧客財產(chǎn)4.7 Control of customer-supplied product 顧客 提供產(chǎn)品的控制7.5.5 Preservation of product 產(chǎn)品防護(hù)7.5.5 Preservation of product 產(chǎn)品防護(hù)4.15.1 Ge neral 總則4.15.2 Han dli ng 處理4.15.3 Storage 儲存4.15.4 Packagi ng 包裝4.15.5 Preservation 防護(hù)7.6 Control of monitoring and

25、measuring equipment監(jiān)視和測量設(shè)備的控制7.6 Control of monitoring and measuring devices監(jiān)視和測量設(shè)備的控制4.11 Con trol of in specti on, measuri ng and test equipment title only檢杳、測量和試驗裝置的 控制4.11.1 Ge neral 總則4.11.2 Control procedure 控制程序8 Measurement, analysis and improvement 測 量、分析和改進(jìn)8 Measurement, analysis and impro

26、vement 測 量、分析和改進(jìn)8.1 General 總則8.1 General 總則4.20.1 Identification of need 需求識別4.20.2 Procedures 程序8.2 Monitoring and measurement 監(jiān)視和測量8.2 Monitoring and measurement 監(jiān)視和測量8.2.1 Customer satisfaction 顧客滿意8.2.1 Feedback 反饋8.2.2 Internal audit 內(nèi)部審核8.2.2 Internal audit 內(nèi)部審核4.17 Internal quality audits 內(nèi)部

27、質(zhì)量審核8.2.3 Mon itori ng and measureme nt of processes 過程的監(jiān)視和測量8.2.3 Mon itori ng and measureme nt of processes 過程的監(jiān)視和測量8.2.4 Monitoring and measurement of product 產(chǎn)品的監(jiān)視和測量8.2.4 Monitoring and measurement of product 產(chǎn)品的監(jiān)視和測量8.2.4.1 General requirements 總要求8.2.4.2 Particular requirement for active impl

28、antable medical devices and implantable medical devices有源植入性醫(yī)療器械和植入性醫(yī)療器械的專用要求4.10 Inspection and testing title only檢驗與試 驗4.10.1 General 總則4.10.3 In-process in spect ion and test ing 工序 檢驗與試驗4.10.4 Final in spect ion and test ing 最終產(chǎn)品檢 驗與試驗4.10.5 Inspection and test records 檢驗與試驗 記錄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 總則4.13.2 Review and dispositi on of nonconforming product不合格品的評審與處置8.4 Analysis o