標準簡介
ISO 13485:2016 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、醫療健康等產業，並適用於全球等市場。
本頁整理了 ISO 13485:2016 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。
Medical Device Specific
Unlike general ISO 9001, this standard is tailored specifically for medical device organizations — addressing regulatory requirements, risk management, and product safety throughout the entire lifecycle.
Risk-Based Approach
Requires risk management to be applied throughout product realization, from design and development through production, storage, distribution, and post-market surveillance.
Global Regulatory Recognition
Recognized by regulatory authorities worldwide including the EU (MDR/IVDR), Canada (CMDCAS), Japan (JPAL), Australia (TGA), and Brazil (ANVISA) — with over 32,000 valid certificates globally.
list_alt Key QMS Requirements
- Quality management system documentation and control
- Management responsibility and commitment
- Resource management and competence
- Product realization planning and risk management
- Design and development controls with verification and validation
- Purchasing and supplier controls
- Production and service provision with process validation
- Monitoring, measurement, and corrective/preventive action
誰需要合規？
Any organization involved in the design, development, production, storage, distribution, installation, servicing, or disposal of medical devices and related services — including component suppliers, contract manufacturers, and sterilization service providers.
關鍵要求
Design & Development Controls
Establish and maintain procedures for design planning, inputs, outputs, reviews, verification, validation, and transfer. Maintain a design history file documenting the entire development lifecycle.
Risk Management
Apply risk management throughout product realization per ISO 14971. Identify hazards, estimate and evaluate risks, implement controls, and verify their effectiveness. Maintain risk management files.
Process Validation
Validate production and service processes where resulting output cannot be fully verified by subsequent inspection or testing — including sterilization, software validation, and cleanroom processes.
Traceability & Post-Market Surveillance
Maintain traceability records for each medical device or batch. Establish procedures for complaint handling, adverse event reporting, and post-market surveillance to identify improvement opportunities.
Supplier Controls
Evaluate and select suppliers based on their ability to meet requirements. Establish purchasing specifications, verify purchased products, and maintain records of supplier performance and approved supplier lists.
實施路線圖
定義醫療器械 QMS 範圍
識別產品族、生命週期活動、場所、外包過程、監管轄區和適用質量體系義務。確認設計、製造、服務、安裝、分銷或軟件活動是否納入範圍。
建立過程和風險控制
映射 ISO 13485 對文件控制、管理職責、資源管理、產品實現、供應商控制、設計開發、滅菌、可追溯性、風險管理和反饋的過程要求。
實施記錄和驗證
部署受控程序、器械主記錄、設計歷史文件、過程確認、軟件驗證、採購記錄、培訓、投訴處理、不合格品、CAPA 和上市後反饋證據。
審覈並維持認證
開展內部審覈和管理評審，關閉 CAPA，準備認證或監管審覈，並在產品、供應商、法規和生產過程變化時維護變更控制。
合規檢查清單
checklist QMS 範圍和治理
checklist 產品實現
checklist 反饋和改進
處罰與執行
ISO 13485 is voluntary, but certification is effectively mandatory for market access in most jurisdictions. Loss of certification can prevent marketing medical devices in the EU (MDR), Canada, Japan, Australia, and other regulated markets. Regulatory authorities may halt production or issue recalls.
常見問題解答
誰需要 ISO 13485？
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ISO 13485 適用於參與醫療器械生命週期一個或多個階段的組織，包括設計、開發、生產、儲存、分銷、安裝、服務及相關支持服務。
ISO 13485 和 ISO 9001 一樣嗎？
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不一樣。ISO 13485 專門面向醫療器械，強調法規要求、風險管理、文件化程序、驗證、可追溯性、投訴處理和產品安全。
ISO 13485 是否要求風險管理？
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是。風險方法嵌入產品實現和 QMS 過程，醫療器械組織通常將 ISO 13485 證據與 ISO 14971 風險管理文件關聯。
ISO 13485 與 FDA QMSR 有何關係？
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FDA 已將 ISO 13485:2016 作爲質量管理體系法規的基礎引用，因此對服務美國市場的製造商尤其重要。
哪些審覈證據最重要？
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審覈員通常期望看到受控程序、設計開發記錄、風險文件、驗證證據、供應商控制、培訓記錄、投訴處理、CAPA、內部審覈和管理評審輸出。