標準簡介
AS9100 Rev D (2016) 是由 美國汽車工程師學會 (SAE) 發布的現行有效標準，常用於航空航天與國防、製造業、科技等產業，並適用於全球等市場。
本頁整理了 AS9100 Rev D (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。
Aerospace-Specific Requirements
Builds on ISO 9001:2015 with additional requirements unique to aviation, space, and defense — including product safety, counterfeit parts prevention, and configuration management.
Product Safety Focus
Rev D introduced a dedicated product safety clause requiring organizations to plan and implement actions to assure the safety of products throughout their lifecycle.
OASIS Database Registration
All AS9100-certified organizations are registered in the IAQG OASIS database, providing a publicly searchable record of certified suppliers for the aerospace supply chain.
list_alt Key AS9100D Additions Over ISO 9001
- Product safety management and reporting
- Counterfeit parts prevention and detection
- Configuration management requirements
- Operational risk management beyond ISO 9001 risk-based thinking
- First Article Inspection (FAI) requirements
- Special process control and validation
- Human factors and awareness of ethical behavior
- On-time delivery performance monitoring
誰需要合規？
Organizations that design, develop, or manufacture products for the aviation, space, and defense industries. Required by major aerospace primes (Boeing, Airbus, Lockheed Martin, etc.) as a condition of supply chain participation.
關鍵要求
Product Safety
Implement processes to manage product safety throughout the product lifecycle. Report safety issues to customers and regulatory authorities. Identify safety-critical items and ensure appropriate controls.
Counterfeit Parts Prevention
Establish processes to detect and prevent the use of counterfeit or suspect unapproved parts. Control procurement sources, verify part authenticity, and report suspected counterfeits to appropriate authorities.
Configuration Management
Maintain configuration identification, control, status accounting, and audit throughout the product lifecycle. Ensure changes are evaluated, approved, and documented before implementation.
Special Processes
Validate special processes (e.g., welding, heat treatment, plating) where the output cannot be fully verified by subsequent inspection. Qualify equipment, personnel, and procedures.
Operational Risk Management
Identify and manage operational risks throughout the realization process. Plan risk mitigation actions for product conformity, on-time delivery, and customer satisfaction beyond the strategic risk approach of ISO 9001.
實施路線圖
定義航空航天質量管理範圍
識別 AS9100 Rev D 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，範圍包括基於 ISO 9001 的 QMS 過程，以及航空航天產品安全、防僞件、配置管理、風險管理、供應商控制、生產控制和放行要求。
評估差距並排列風險優先級
將當前實踐與預期的航空航天質量管理方法進行比較。審查過程責任、配置記錄、首件檢驗、供應商資格、特殊過程控制、不合格處理、糾正措施和客戶要求傳遞，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。維護質量手冊或過程圖、風險記錄、配置基線、FAI 報告、供應商批准、生產流轉單、檢驗記錄、NCR、CAPA 和管理評審輸出作爲可追溯證據。
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 legal penalties — AS9100 is an industry-driven standard. However, loss of certification results in removal from the IAQG OASIS database and effectively bars organizations from supplying to major aerospace OEMs and their supply chains.
常見問題解答
誰需要 AS9100 Rev D？
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AS9100 Rev D 最適用於需要航空航天 QMS 認可的航空、航天和國防供應商。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。
AS9100 Rev D 是否可認證？
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AS9100 認證通常由航空航天客戶要求，並通過認可認證和 OASIS 供應商可見性進行管理。
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。
AS9100 Rev D 需要哪些證據？
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有用證據包括質量手冊或過程圖、風險記錄、配置基線、FAI 報告、供應商批准、生產流轉單、檢驗記錄、NCR、CAPA 和管理評審輸出。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。