| 姓名 |
陳柏旭(Po-Hsu Chen)
查詢紙本館藏 |
畢業系所 |
高階主管企管碩士班 |
| 論文名稱 |
從電子產品轉型為醫療器械品質管理系統施行策略實例研究
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| 相關論文 | |
| 檔案 |
 [Endnote RIS 格式]
[Bibtex 格式]
 [相關文章]  [文章引用]  [完整記錄]  [館藏目錄]  至系統瀏覽論文 ( 永不開放)
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| 摘要(中) |
隨著現代社會的產業持續發展，我們發現產業間的壁壘日漸模糊，電子代工業去做垂直整合加入上下段製程以提高利潤率、品牌商如作手機的小米跨足智能家電領域、軟體巨擘微軟打著它們期望的PC旗號展開硬體領域的競爭，這類型的跨產業商業投入已時有所聞，甚至獲得了相當大的成功，但面對極爲嚴謹要求資質的醫療類產品，涉足跨商業的情況就較爲罕見，本研究希望針對電子製造服務(EMS; Electronic Manufacturing Service) 跨醫療產品的實際案例，探討面臨的問題與實際解決方案。
P公司是其中一家將跨足醫療器械生產的大型企業，目前已經有了ISO 9001品質管理系統(由國際標準組織建立的基於自願申請的品質管理系統)，基於成本和時間等多方因素的考慮，完全推倒重新建立醫療器械品質系統既不經濟也耗時頗巨。因此，在現有品質系統基礎上建立符合ISO 13485(依各國法規規定須強制認證的醫療器械品質管理系統)和FDA 21 CFR 820(Foot and Drug Administration食品及藥物管理局，21 CFR 820為醫療器材品質系統法規)法規要求的醫療器械品質系統成為P公司的最佳選擇方案。
本文首先對ISO 9001品管系統、ISO 13485醫療器械品管系統和21 CFR 820法規的相關概念、理論及不同的要求進行了系統性的闡述，並對策略制定和實施以及項目管理的相關理論框架進行了研究和梳理。通過對三種系統的框架、關注側重點、文件體系等方面系統地進行比較分析，歸納總結出在原有系統的基礎上建立醫療法規系統的切入點及所需解決的問題，接著運用策略制定的原則和方法，結合P公司的實際情況，採用項目管理的方法從策略實施計畫的評估和溝通、制定策略實施架構、策略實施支持計畫的制定、資源預算和分配以及職能及活動的履行等方面開始實施直至完善醫療品質系統的建立並取得相應合格認證證書與稽核的過程，完成了本文的研究範圍。
通過本文的研究範例，對有類似情形的企業如何分析不同系統間的差異並制定正確的實施策略，最終在較短的時間以較低的成本儘快建立符合法規要求的醫療器械品質管理系統，從而改善和促進企業的醫療器械品質管理理念甚至業務結構優化都有著較大的參考意義。 |
| 摘要(英) |
With the continuous development of industries in modern society, we find that the barriers between industries are becoming increasingly blurred. Cross-industry business investment has been heard from time to time and even achieved considerable success, such as the increasing profitability the electronics manufacturing industry has gotten through the vertical integration, joining the upper and lower stages of the manufacturing process; Brands, such as Xiaomi has stepped into the field of smart appliances and software giant Microsoft has launched competition in the field of hardware in the name of their expected PC. However, in the face of medical products with strict qualification requirements, it is rare to get involved in cross-business. This study aims to explore the problems and practical solutions for EMS (Electronic Manufacturing Service) cross-medical products in the context of actual cases.
P company is one of the large enterprises that will step into the production of medical equipment, and currently has already had ISO 9001 quality management system (a voluntary-based quality management system established by the international standards organization). Considering many factors such as cost and time, it is neither economical nor time-consuming to completely push down and re-establish the medical equipment quality system. Therefore, the quality management system, based on the existing quality system to meet the requirements of ISO 13485 (medical device quality management system that requires mandatory certification according to national regulations) and FDA 21 CFR 820 (Foot and Drug Administration, 21 CFR 820, the medical equipment quality system regulation), is undoubtedly the best choice for P company.
In this paper, the concepts, theories and different requirements of ISO 9001, ISO 13485 and 21 CFR 820 are expounded systematically, and the theoretical framework for strategy formulation and implementation as well as project management is studied and sorted out. By comparing and analyzing the framework, focus, and document system of them, we have summarized the entry points and problems to be solved for establishing a medical device quality management systmen based on the original one. Then using the principles and methods of strategy formulation, combined with the actual situation of P company; adopting the method of project management to evaluate and communicate the strategy implementation plan; formulating the strategy implementation framework and the relative supporting plans; resource budget and allocation, and the performance of functions and activities to the establishment of the completed medical device quality system and obtaining corresponding qualification certificate and audits, this paper will be completed.
Through the research examples in this paper, it is of great reference value for enterprises in similar situations to analyze the differences between different systems and formulate correct implementation strategies, so as to eventually establish a medical device quality management system that meets regulatory requirements in a shorter period of time and at a lower cost, thereby improving and promoting the medical device quality management concept and even business structure optimization. |
| 關鍵字(中) |
★ 品質管理系統
★ 電子製造服務 |
關鍵字(英) |
★ quality management system
★ Electronic manufacturing service |
| 論文目次 |
第一章 緒論 1
1.1 研究背景 1
1.2 近期各國對醫療器械管理發展 2
1.3 研究對象 3
1.4 研究方法 5
第二章 醫療器械品質管理系統綜述及差異分析 6
2.1 ISO 13485醫療器械品質管理系統 6
2.2 ISO 13485與ISO 9001的主要差異 8
2.3 FDA醫療器械品質管理系統法規 13
2.4 FDA 21 CFR 820對比ISO 13485:2016管制差異分析 20
第三章 P公司跨醫療器械品質管理系統對比現狀分析 26
3.1 P公司跨醫療產業分析 26
3.2 P公司現有品質管理系統狀況 31
3.3 P公司現有品質管理系統優缺點分析 33
3.3.1 P公司現有品質管理系統優點 34
3.3.2 P公司現有品質管理系統缺點 34
3.4 實施FDA法規存在問題分析 36
第四章 P公司實施醫療器械品質管理系統策略 38
4.1 策略實施綜述 38
4.2 策略實施規劃 39
4.3 策略目標 40
4.4 策略計劃 41
4.4.1 計劃藍圖 42
4.4.2 資源準備 44
4.5 策略管理 46
4.5.1 組織面的強化 47
4.5.2 不適用條款排除 48
4.5.3 品質管理系統文件完善及培訓 49
4.5.4 電子簽名系統 58
4.5.5 設立DHF、DMR、DHR 59
4.5.6 標識和可追溯性(批紀錄、批放行) 61
4.5.7 導入ISO 14971風險管理 63
4.5.8 第三方顧問公司輔導 65
4.5.9 GDP優良文件化規範 66
4.5.10 製程確效、軟體確效 66
4.5.11 內部稽核與管理審查計畫與實施 70
4.5.12 內外溝通 71
4.5.13 全員品質意識與教育訓練 73
4.6 策略驗收 74
4.7 策略實現 75
第五章 總結 76
5.1 P公司施行結果與研究結論 76
5.2 未來法規發展 77
5.3 研究限制 78
5.4 研究論述 79
參考文獻 81 |
| 參考文獻 |
一、中文文獻
Project Management Institute，2018，项目管理知识体系指南，电子工业出版社。
工業技術研究院，2015，2015醫療器材產業年鑑。
吳曉波，黃燦與約翰•彼得•莫爾曼(Johann Peter Murmann)，2017，華為管理變革，中信出版社。
约瑟夫•M•朱兰(Joseph M. Juran)，焦叔斌等译，2010，朱兰质量手册，中国人民大学出版社。
胡咏梅，2018，2017年我国医疗人工智能产业发展现状及发展趋势：医疗器械蓝皮书，社会科学文献出版社。
財團法人醫藥品查驗中心，2016，美國高風險醫療器材的上市送件流程，當代醫藥法規月刊，68期：9-20。
韩福荣，2012，现代质量管理学，机械工业出版社。
黄嘉华，2008，医疗器械注册与管理，科学出版社。
谭民望，2007，中国医疗器械产业发展之路，中国医药科技出版社。
衛生福利部食品藥物管理署，2017，醫療器材軟體確效指引。
二、英文文獻
Daniel, A., Kimmelman, E. (2008) The FDA and worldwide quality system requirements guidebook for medical devices. ASQ Quality Press.
European Union (1993) Council directive 93/42/EEC of 14 June 1993: concerning medical devices.
FDA (2021) PMA Review Process.
FDA (2020) How to Study and Market Your Device.
FDA (2020) PMA Approvals.
FDA (2020) PMA Application Contents.
FDA (2019) Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).
FDA (2018) Medical Device User Fee Small Business Qualification and Certification.
FDA (2018) Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation.
FDA (2018) Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process.
FDA (2018) PMA Application Methods.
FDA (2018) Who Must Register, List and Pay the Fee.
FDA (2013) Medical Device Recall Report FY2003 to FY2012.
U.S. Government (2022) Title 21 Code of Federal Regulation Part 11: Electronic Records; Electronic Signatures. U.S. Government Publishing Office (GPO).
U.S. Government (2020) Title 21 Code of Federal Regulation Part 820: Quality System Regulation. U.S. Government Publishing Office (GPO).
International Electrotechnical Commission (2015) IEC 62304 – medical device software – software life cycle processes.
ISO (2019) ISO 14971:2019 Medical devices - Application of risk management to medical devices.
ISO (2018) FDA plans to use ISO 13485 for medical devices regulation.
ISO (2016) ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
Rodríguez-Pérez, J. (2010) CAPA for the FDA-Regulated Industry. ASQ Quality Press.
Lewis, J.P. (2011) Project planning, scheduling and control. McGraw-Hill. |
| 指導教授 |
呂俊德
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審核日期 |
2023-5-15 |
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