標準簡介
ISO 14971:2019 是由 國際標準化組織 (ISO) 發布的現行有效標準，常用於醫療器材、醫療健康、科技等產業，並適用於全球等市場。
本頁整理了 ISO 14971:2019 的官方文件、目前狀態以及常見相關認證或評估機構，便於快速理解要求與落地路徑。
Full Lifecycle Coverage
Applies risk management across the entire medical device lifecycle — from initial concept and design through production, post-market surveillance, and decommissioning.
Benefit-Risk Analysis
The 2019 edition places greater emphasis on the overall benefit-risk ratio, requiring manufacturers to weigh clinical benefits against residual risks systematically.
Continuous Process
Risk management is not a one-time activity but an ongoing process that integrates post-production information and state-of-the-art knowledge into risk evaluations.
list_alt Risk Management Process Steps
- Risk management planning and scope definition
- Hazard identification and hazardous situation analysis
- Risk estimation and risk evaluation against acceptability criteria
- Risk control option analysis and implementation
- Evaluation of overall residual risk
- Risk management review and reporting
- Production and post-production information collection
- Integration with ISO 13485 quality management system
誰需要合規？
All medical device manufacturers, including software-as-a-medical-device (SaMD) and in vitro diagnostic (IVD) device makers. Required by the EU MDR, FDA, and most global regulatory frameworks.
關鍵要求
Risk Management Plan
Establish a documented risk management plan defining scope, responsibilities, risk acceptability criteria, verification activities, and review requirements for the entire product lifecycle.
Hazard Identification & Risk Analysis
Systematically identify known and foreseeable hazards in both normal and fault conditions. Estimate risks by analyzing severity of harm and probability of occurrence for each hazardous situation.
Risk Control Measures
Implement risk controls following the priority hierarchy: inherent safety by design, protective measures in the device or manufacturing process, and information for safety (labeling, instructions).
Overall Residual Risk Evaluation
Evaluate the overall residual risk from all identified hazards after all risk control measures are applied, and determine whether the medical benefits outweigh the remaining risks.
Post-Production Monitoring
Collect and review production and post-production information including complaint data, incident reports, and published literature to identify previously unrecognized hazards or risks.
實施路線圖
定義醫療器械風險管理範圍
識別 ISO 14971:2019 覆蓋的產品、服務、場所、系統、團隊、司法轄區和相關方。確認責任人、邊界、適用義務、文件和證據期望，範圍包括危險識別、可預見誤用、風險估計、風險評價、風險控制、剩餘風險可接受性、收益風險分析、生產信息和上市後監視。
評估差距並排列風險優先級
將當前實踐與預期的醫療器械風險管理方法進行比較。審查風險管理計劃、危險分析、控制驗證、剩餘風險評價、風險管理報告、生產反饋和上市後監督關聯，並按法律暴露、安全影響、客戶承諾、運營依賴以及審覈或市場準入準備度排列差距優先級。
實施控制和記錄
部署所需程序、技術控制、評審關口、培訓、供應商流程、報告路徑和運行記錄。維護風險管理文件、危險分析、FMEA 或等效分析、驗證記錄、收益風險決策、可用性關聯、投訴數據和上市後評審作爲可追溯證據。
評審、審覈並改進
開展內部評審、管理報告、審覈、糾正措施和變更評估。當產品、服務、供應商、技術、法規、事件或相關方期望變化時刷新項目。
合規檢查清單
checklist 範圍與治理
checklist 控制與證據
checklist 監控與改進
處罰與執行
No direct penalties for non-compliance with the standard itself. However, failure to demonstrate adequate risk management can result in rejection of regulatory submissions, product recalls, and market access denial under the EU MDR, FDA 21 CFR 820, and other regulations.
常見問題解答
誰需要 ISO 14971:2019？
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ISO 14971:2019 最適用於在全生命週期管理產品風險的醫療器械和 IVD 製造商。具體範圍取決於產品、服務、司法轄區、客戶承諾，以及組織是否需要認證、符合性證據、監管準備或內部治理。
ISO 14971:2019 是否可認證？
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ISO 14971 通常通過醫療器械 QMS 和監管審覈進行檢查，而不是單獨認證。
實施時應先關注什麼？
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先定義範圍和義務，再建立當前狀態差距評估。早期最重要的工作是確認責任、受影響資產或過程、風險準則、客戶或法律驅動因素，以及組織必須能夠提供的證據。
ISO 14971:2019 需要哪些證據？
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有用證據包括風險管理文件、危險分析、FMEA 或等效分析、驗證記錄、收益風險決策、可用性關聯、投訴數據和上市後評審。證據應進行版本控制，能夠追溯到責任人，並關聯風險、義務、控制、決策和糾正措施。
項目應多久評審一次？
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應按計劃週期評審，並在產品、服務、供應商、運行環境、事件、客戶承諾或法規變化時評審。高風險領域應採用更頻繁的監控和管理報告。