ISO 差異分析

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1 1/7 ISO Medical devices Quality management systems Requirements for regulatory purposes ISO 13485:2016 與 2003 年版之差異分析新版重點 : 針對醫療器材專有名詞作更明確的定義整合全球法規要求整合風險管理與以及在整個品質管理系統中以風險為基礎進行決策針對醫療器材檔案 (medical device file) 提出更明確的架構針對查證確認與設計管制提出更清楚的要求強化供應鏈的管制加強對回饋機制的關注針對各種軟體應用, 提出更明確的軟體確認 (software validation) 要求新版特別強調的關鍵辭彙 : Regulatory 法規 Validation 確認 Sterile 無菌 Software 軟體 Proportionate to the risk associated with the medical device 與醫療器材風險成比例的對應關係架構 : 無變更, 維持 8 章節緩衝期 : 3 年, 至 2019 年 2 月內容差異 : 2003 年版刪除條款 2016 年新版增加條款與條款編碼 Foreword Foreword 前言 0 Introduction Introduction 簡介 0.1 General 0.1 General 概述 Clarification of concepts 0.2 Process approach 0.2 釐清概念 Relationship with other Process approach standards 流程方法 Relationship with ISO Relationship with ISO/TR 14969

2 2/7 0.4 Compatibility with other Relationship with ISO management systems 與 ISO 9001 之關連性 Compatibility with other management 0.5 systems 與其他管理系統之相容性 1 Scope 1 Scope 範圍外包商的管理責任, 包括監控維持以及管理外包的流程排除條款範圍增加到條款 6 與 8 明確定義法規要求, 針對品質管理系統與醫療器材之性能與安全性 1.1 General 1.2 Application 2 Normative references 2 3 Terms and definitions 3 4 Quality management system 4.1 General requirements Documentation requirements Normative references 參考準則 Terms and definitions 辭彙與定義 Quality management system 品質管理系統 General requirements 一般要求 General General 概述 Quality manual Control of documents Control of records Management responsibility Management commitment 5.1 Documentation requirements 文件要求 Quality manual 品質手冊 Medical device file 醫療器材檔案 Control of documents 文件之管制 Control of records 紀錄之管制 Management responsibility 管理責任 Management commitment 管理承諾辭彙由 8 個增加為 20 個 ( 附錄 1) 新增 13/ 保留 5, 並更新解釋 / 刪除 3 增加依據適用法規要求, 其相關權責角色應文件化 ( 製造廠, 授權代表, 進口商或經銷商 ) 依據組織所從事的角色來決定流程以風險為基礎之考量流程之變更之管控應用在品質管理系統的軟體, 應有文件化確認程序, 與確認相關要求增加必要的文件, 包括紀錄以確保有效的計畫生產以及控制其過程新條款對於每一個醫療器材型號或系列, 組織應建立與維持一個或多個檔案, 包含或引用產出之文件以證明符合此國際標準與適用法規之要求增加依據適用的法規要求, 保護紀錄中所包含的機密醫療訊息

3 3/7 5.2 Customer focus 5.2 Customer focus 顧客為重 5.3 Quality policy 5.3 Quality policy 品質政策 5.4 Planning 5.4 Planning 規劃 Quality objectives Quality objectives 品質目標 Quality management Quality management system planning system planning 品質管理系統之規劃 5.5 Responsibility, authority and Responsibility, authority 5.5 communication and communication 責任權限與溝通 Responsibility and authority Responsibility and authority 責任與權限 Management Management representative representative 管理代表 Internal communication Internal communication 內部溝通 5.6 Management review 5.6 Management review 管理審查 General General 概述增加管理審查應文件化, 包括審查頻率 Review input Review input 增加至 12 項審查之輸入 Review output Review output 增加至 4 項審查之輸出 6 Resource management 6 Resource management 資源管理 6.1 Provision of resources 6.1 Provision of resources 資源之提供 6.2 Human resources 6.2 Human resources 增加組織應對於能力提供所需之訓練及人力資源人員認知建立文件化程序 General Competence, awareness and training 6.3 Infrastructure Work environment Product realization Planning of realization 7.1 Infrastructure 基礎設施 Work environment and contamination control 工作環境與汙染控制 Work environment 工作環境 Contamination control 汙染控制 Product realization 產品實現 Planning of realization 產品實現之規劃增加文件化基礎設施之要求支援服務包括訊息系統增加文件化工作環境之要求增加針對無菌醫療器材, 應文件化要求控制微生物或顆粒物之汙染增加資源提供包括基礎設施與工作環境產品所需要活動增加處理儲存分發與追溯

4 4/7 7.2 Customer-related processes 7.2 Customer-related processes 顧客相關之過程 Determination of Determination of requirements related 增加 requirements related to the to 產品相關要求之決定使用者之教育訓練 Review of requirements related to the Review of requirements related to 產品相關要求之審查 Customer communication Communication 溝通增加與主管機關溝通聯繫設計開發 General 概述 planning inputs outputs review verification validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased Production and service provision Control of ion and service provision planning 設計開發之規劃 inputs 設計開發之輸入 outputs 設計開發之輸出 review 設計開發之審查 verification 設計開發之查證 validation 設計開發之確認 transfer 設計開發之移轉 Control of design and development changes 設計開發變更之管制 files 設計開發檔案 Purchasing 採購 Purchasing process 採購過程 Purchasing information 採購資訊 Verification of purchased 採購品之查證 Production and service provision 生產與服務提供 Control of ion and service provision 生產與服務提供之管制刪除組織應管理參與設計開發各團體間的界面, 以確保有效的溝通與明確的職責分工增加增加至 6 項增加將可用性加入 (IEC ) 增加紀錄要求 : 設計鑑別參與人員日期增加文件化查證計畫 / 介面或機台整合之考量 / 紀錄之要求增加文件化確認計畫 / 介面或機台整合之考量 / 紀錄之要求新條款增加評估變更之影響重大變更的判斷新條款增加供應商的選擇 / 績效與風險管理之連結供應商績效的監控與再評估未能滿足需求之採購, 所應採取之措施相關紀錄要求增加採購產品的變更通知之要求增加採購品變更之判斷與查證之要求增加管控之細節要求

5 5/ General requirements Cleanliness of 增加至 5 項產品之清潔 Control of ion and service provision Specific requirements Cleanliness of and contamination control Installation activities Installation activities 安裝活動 Servicing activities Servicing activities 增加服務活動分析服務活動的紀錄之要求 Particular requirements for sterile Particular requirements for medical devices sterile medical devices 無菌醫療器材之特殊要求 Validation of processes for ion and service provision Validation of processes for ion and service provision 生產與服務提供過程之確認 General requirements Particular requirements for sterile medical devices Identification and traceability 確認的文件化程序之內容增加至 7 項並增加確認與再確認執行時機 / 軟體確認 / 確認紀錄之要求 Particular requirements for validation 增加 of processes for sterilization and 無菌包裝材確效之文件化程序與要求 sterile barrier systems 滅菌過程與無菌包裝材之確效特殊要求 Identification Identification 識別增加單一識別系統 (unique device identification) 之需求與文件化識別要求 Traceability Traceability 追溯 General Particular requirements for active implantable medical devices and implantable medical devices Status identification Customer property Customer property 客戶財產 Preservation of Preservation of 增加細節要求產品防護 7.6 Control of monitoring and measuring Control of monitoring and 7.6 equipment measuring devices 監控與量測儀器之管制 8 Measurement, analysis and Measurement, analysis and 8 improvement improvement 量測分析與改善 8.1 General 8.1 General 概述 8.2 Monitoring and measurement Feedback Monitoring and measurement 監控與量測 Feedback 回饋增加回饋資訊的收集時機

6 6/7 回饋資訊與風險管理之連結 Internal audit Monitoring and measurement of processes Monitoring and measurement of General requirements Particular requirement for active implantable medical devices and implantable medical devices Control of nonconforming General 概述 Analysis of data Improvement General Corrective action Preventive action Annex A Annex B (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996 (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 Bibliography Annex A Annex B Complaint handling 訴怨處理 Reporting to regulatory authorities 呈報主管機關 Internal audit 內部稽核 Monitoring and measurement of processes 過程的監控與量測 Monitoring and measurement of 產品的監控與量測 Control of nonconforming 不合格品之管制 Actions in response to nonconforming detected before delivery 交貨前發現不合格品所採取之措施 Actions in response to nonconforming detected after delivery 交貨後發現不合格品所採取之措施 Rework 重工 Analysis of data 資料分析 Improvement 改善 General 概述 Corrective action 矯正措施 Preventive action 預防措施 (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016 ISO 新版與 2003 年版之內容差異 (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 ISO 13485:2016 與 ISO 9001:2015 之關聯性 Bibliography 參考標準新條款新條款增加紀錄之要求不合格品的各項管控都應文件化增加紀錄之要求與特採之要求增加措施之要求與特採之要求增加紀錄之要求與建議性通告 (2003 年版 8.5.1) 相關要求增加要求適當的分析方法統計技術與使用範圍增加資料分析輸入項目 - 稽核活動增加查證要求與時效性增加查證要求由 15 項減少為 13 項 ( 附錄 2) 新增 11/ 保留 2/ 刪除 13

7 7/7 附錄 1 辭彙與定義 : - 辭彙由 8 個增加為 20 個 1. 建議性通告 advisory notice 2. 授權代表 authorized representative (GHTF/SG1/N055:2009, 5.2) 3. 臨床評估 clinical evaluation (GHTF/SG5/N4:2010, 4) 4. 訴怨 complaint 5. 經銷商 distributor (GHTF/SG1/N055:2009,5.3) 6. 植入式醫療器材 implantable medical device 7. 進口商 importer (GHTF/SG1/N055:2009, 5.4) 8. 標籤 labelling (GHTF/SG1/N70:2011, Clause 4]) 9. 生命週期 life-cycle (ISO 14971:2007, 2.7) 10. 製造商 manufacturer (GHTF/SG1/N055:2009, 5.1) 11. 醫療器材 medical device (GHTF/SG1/N071:2012, 5.1) 12. 醫療器材系列 medical device family 13. 性能評估 performance evaluation 14. 上市後監督 post-market surveillance 15. 產品 16. 採購品 purchased 17. 風險 risk (ISO 14971:2007, 2.16) 18. 風險管理 risk management (ISO 14971:2007, 2.22) 19. 無菌包裝材 sterile barrier system (ISO :2006, 3.22) 20. 無菌醫療器材 sterile medical device 附錄 2 參考標準 : - 由 15 項標準減少為 13 項標準 1. ISO 9001:2015, Quality management systems Requirements 2. ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment 3. ISO :2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems 4. ISO , Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes 5. ISO (all parts), Cleanrooms and associated controlled environments 6. ISO (all parts), Cleanrooms and associated controlled environments Biocontamination control 7. ISO 14971:2007, Medical devices Application of risk management to medical devices 8. ISO 19011, Guidelines for quality and/or environmental management systems auditing 9. IEC , Medical devices Part 1: Application of usability engineering to medical devices 10. GHTF/SG1/N , Definition Terms Manufacturer Authorized representative Distributor and Importer 11. GHTF/SG5/N , Post-Market Clinical Follow-Up Studies 12. GHTF/SG1/N , Label and Instructions for Use for Medical Devices 13. GHTF/SG1/N , Definition of terms Medical Device and In Vitro Diagnostic Medical Device

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