ISO 9001:2015《品質管理系統 - 要求》

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配合國際標準化組織 (ISO) /國際電工委員會 (IEC) 2014 年所發行的 ISO/IEC 指令第 1 部 (ISO/IEC Directives Part 1) 《國際標準組織綜合補充、ISO 專屬程序》(Consolidated ISO supplement - Procedure specific to ISO) 之附錄 SL (Annex SL)《管理系統標準建議》(Proposals for management system standards) 所規定的管理系統標準高階架構 (high level structure, HLS) 要求，國際標準化組織 (ISO) 第 176 號技術委員會 (ISO/TC 176) 第 2 子委員會 (SC 2) 負責修訂的 2015 年版 ISO 9001:2015《品質管理系統 - 要求》(Quality management systems - Requirements)。ISO 9001:2015 草稿版 (draft international standard, DIS) 於 2014 年 5 月 13 日發行， 2014 年 7 月10 日開始投票、2014 年10月10 日截止投票。最終草稿版 (final draft international standard, FDIS) 於 2015 年 7 月 9 日開始由有興趣的會員國投票，2015 年 9 月 9 日截止。

ISO 9001:2015 國際標準正式版 (international standard, IS) 於 2015 年 9 月 15 日發行。新版本發行之後，依照慣例，預計會有三年的改版緩衝期。

ISO 9001:2015 是以風險為基礎（風險為基）(risk-based) 的品質管理國際標準，強調品質管理系統必須依照組織特性與個性，參考 ISO 9000 系列精神與原理加以客製完成。ISO 9001:2015 並不要求統一一致的品質管理系統，那是認證系統相關者的觀點。

ISO 9001:2015 強調變更管理與組織知識的傳承與創新，所以 2015 年版的發行並不要求組織的既有品質管理系統必須廢掉重新改寫，才能通過改版認證。若你的驗證公司要你原有的品質管理系統相關規定及（或）文檔廢掉重寫，把它 fire 掉換一家驗證公司，並記得向 IAF 與 TAF 寄存證信函，以維持公正無私的紀律！

ISO 推動 MSS 的目的在於強調組織（包括ISO 本身）對於文件管制應遵循一致的管理系統標準，包括格式、內容等。為了達到身教重於言教、以身作則的精神， 因此要求各技術委員會在研擬各種管理系統時，必須遵循 ISO 指令第 1 部對於 HLS（文件）架構的相關規定。

參考資料：

• ISO/TC 176/SC 2/WG 24/N112, ISO/DIS 9001:2014, Quality management systems - Requirements, 2014-05-13.
• ISO/TC 176/SC 2/N1147, ISO/CD 9001:2013, Quality management systems - Requirements, 2013-06-03.
• ISO/TC 176/SC 2/WG 244/N81, ISO/WD 9001:2012, Quality management systems - Requirements, 2012-06.
• ISO/IEC Directive Part 1, Consolidated ISO supplement - Procedure specifice to ISO, 2004 and 2005 corrected version.
• ISO Annex SL (normative) Proposals for management system standards
• ISO/FDIS 9001:2015, Quality management systems - Requirements
• ISO/FDIS 9001:2015 FDIS Transition Checklists
• IAF, Transition Planning Guidelines for ISO 9001:2015 issue 1, 12 Jan. 2015.
• 標檢局，ISO 9001:2015 標準簡介
  

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ISO 9001:2015 第五版的改版歷程如下：

• 國際標準：ISO 9001:2015, 2015-09-15
• 國際標準最終草稿版：ISO/FDIS 9001:2015, Final Draft International Standard, 2015-07-09
• 國際標準草稿版：ISO/DIS 9001:2014, Draft International Standard, ISO/TC 176/SC 2/WG 24/N112, 2014-05-13.
• 委員會草稿版：ISO/CD 9001:2013, ISO/TC 176/SC 2 Committee Draft, ISO/TC 176/SC 2/N1147, 2013-06-03.
• 工作小組草稿版：ISO/WD 9001:2012, ISO/TC 176 SC 2 WG 24 Working Draft, ISO/TC 176/SC 2/WG 244/N81, 2012-06.
• 第四版：ISO 9001:2008, ed. 4.0, International Standard, 2008-11-15.
  

Source: ISO 網站

FDIS 版與 DIS 版的差異：

• 相較於 DIS 版，改變不多。
• 簡化「簡介」的內容及附圖。
• 第 3 章「名詞與定義」的詳細內容移到 ISO 9000。
• 除了過程方式 (process approach) 之外，高層管理必須促進風險為基思維 (risk-based thinking) 的使用。
• 增加過程環境應用於服務組織的解釋。
• 包含防止人員誤差的生產與服務活動要求。
  

ISO 9001:2015 與 ISO 9001:2008 之用語主要差異
ISO 9001:2008	ISO 9001:2015
產品 Products	產品與服務 Products and services
排除 Exclusions	不使用 Not used （參閱第 A.5 節有關應用性之澄清） (See Clause A.5 for clarification of applicability)
管理代表 Management representative	不使用 Not used (指定類似的責任與權利，但無單一管理代表要求) (Similar responsibilities and authorities are assigned but no requirements for a single management representative)
文件化、品質手冊、文件化程序書、紀錄 documentation, quality manual, documented procedures, records	文件化資訊、建檔資訊 documented information
工作環境 Work environment	過程運作環境 Environment for the operation of processes
監視與量測設備 Monitoring and measuring equipment	監測與量測資源 Monitoring and measuring resources
採購產品 Purchased product	外部供應產品與服務 Externally provided products and services
供應商	外部供應者

表：ISO 9001:2015 WD、CD 、DIS 及 FDIS 版比較
ISO 9001:2015 WD 版章節	ISO 9001:2015 CD 版章節	ISO 9001-2015 DIS 版章節	ISO 9001:2015 FDIS 版章節
ISO/TC 176/SC 2/WG 244/N 81 (2012)	ISO/TC 176/SC 2/N 1147 (2013-06-03)	ISO/DIS 9001:2014 (2014-05-13)	ISO/FDIS 9001:2015 (2015-07-01)
前言 (foreword)	前言 (foreword)	前言 (foreword)	前言 (foreword)
簡介 (introduction)	簡介 (introduction)	簡介 (introduction)	簡介 (introduction)
(秘書處：待發展)	0.1 概述 (general) 0.2 附錄 SL (annex SL) 0.3 顯著變更 (significant changes)	0.1 概述 (general) 0.2 ISO 品質管理標準(the ISO standards for quality management) 0.3 過程方式 (process approach) 0.4 規劃-執行-檢核-行動循環 (plan-do-check-act cycle) 0.5 基於風險思考 (risk-based thinking) 0.6 與其他管理系統標準之相容性 (compatibility with other management system standards)	0.1 概述 (general) 0.2 品質管理原則 (quality management principles) 0.3 過程方式 (process approach) 0.3.1 概述 (general) 0.3.2 規劃-執行-檢核-行動循環 (plan-do-check-act cycle) 0.3.3 基於風險思考 (risk-based thinking) 0.4 與其他管理系統標準之關係 (relationship with other management standards)
1. 範圍 (scope)	1. 範圍 (scope)	1. 範圍 (scope)	1. 範圍 (scope)
2. 規範性引用文件 (normative references)	2. 規範性引用文件 (normative references)	2. 規範性引用文件 (normative references)	2. 規範性引用文件 (normative references)
3. 名詞與定義 (terms and definitions)	3. 名詞與定義 (terms and definitions)	3. 名詞與定義 (terms and definitions)	3. 名詞與定義 (terms and definitions)
4. 組織情景 (context of the organization)	4. 組織情景 (context of the organization)	4. 組織情景 (context of the organization)	4. 組織情景 (context of the organization)
4.1 瞭解組織及其情景  (understanding the organization and its context) 4.2 瞭解有興趣團體之需要與期望 (understanding the needs and expectations of interested parties) 4.3 決定品質管理系統之範疇 (determining the scope of the quality management system) 4.4 品質管理系統 (quality management system)	4.1 瞭解組織與其情景 (understanding the organization and its context) 4.2 瞭解有興趣團體之需要與期望 (understanding the needs and expectations of interested parties) 4.3 決定品質管理系統之範疇 (determining the scope of the quality management system) 4.4 品質管理系統 (quality management system) 4.4.1 概述 (general) 4.4.2 過程方式 (process approach)	4.1 瞭解組織及其情景 (understanding the organization and its context) 4.2 瞭解有興趣團體之需要與期望 (understanding the needs and expectations of interested parties) 4.3 決定品質管理系統之範圍 (determining the scope of the quality management system) 4.4 品質管理系統及其過程 (quality management system and its processes)	4.1 瞭解組織及其情景 (understanding the organization and its context) 4.2 瞭解有興趣團體之需要與期望 (understanding the needs and expectations of interested parties) 4.3 決定品質管理系統之範圍 (determining the scope of the quality management system) 4.4 品質管理系統及其過程 (quality management system and its processes)
5. 領導 (leadership)	5. 領導 (leadership)	5. 領導 (leadership)	5. 領導 (leadership)
5.1 領導及承諾 (leadership and commitment)   5.2 政策 (policy)   5.3 組織角色、職責及職權 (organizational roles, responsibilities and authorities)	5.1 領導及承諾 (leadership and commitment) 5.1.1 關於品質管理系統之領導及承諾  (leadership and commitment with respect to the quality management  system) 5.1.2 關於顧客需要及期望之領導與承諾  (leadership and commitment with respect to the needs and  expectations of customers) 5.2 品質政策 (quality policy) 5.3 組織角色、職責及職權 (organization roles, responsibilities and authorities)	5.1 領導及承諾  (leadership and commitment) 5.1.1 品質管理系統之領導及承諾 (leadership and commitment for quality management system) 5.1.2 顧客聚焦 (customer focus) 5.2 品質政策 (quality policy) 5.3 組織角色、職責及職權 (organizational roles, responsibilities and authorities)	5.1 領導及承諾 (leadership and commitment) 5.1.1 概述 (general) 5.1.2 顧客聚焦 (customer focus) 5.2 品質政策 (quality policy) 5.2.1 建立品質政策(establishing the quality policy) 5.2.2 溝通品質政策 (communicating the quality policy) 5.3 組織角色、職責及職權 (organizational roles, responsibilities and authorities)
6. 規劃 (planning)	6. 規劃 (planning)	6. 規劃品質管理系統 (planning for quality management system)	6. 規劃 (planning)
6.1 強調風險及機會之行動 (actions to address risks and opportunities) 6.2 品質目標及達標之規劃 (quality objectives and planning to achieve them) 6.3 變更之規劃及控制 (planning and control of changes)	6.1 強調風險及機會之行動 (actions to address risks and opportunities) 6.2 品質目標及達標之規劃 (quality objectives and planning to achieve them) 6.3 變更之規劃 (planning of changes)	6.1 強調風險及機會之行動 (actions to address risks and opportunities) 6.2 品質目標及達標之規劃 (quality objectives and planning to achieve them) 6.3 變更之規劃 (planning of changes)	6.1 強調風險及機會之行動 (actions to address risks and opportunities) 6.2 品質目標及達標之規劃 (quality objectives and planning to achieve them) 6.3 變更之規劃 (planning of changes)
7. 支援 (support)	7. 支援 (support)	7. 支援 (support)	7. 支援 (support)
7.1 資源 (resources) 7.1.1 概述 (general) 7.1.2 基礎設施與工作環境 (infrastructure and work environment) 7.1.3 監視及量測儀器 (monitoring and measuring instruments) 7.1.4 知識要求 (knowledge requirements) 7.2 職能 (competence) 7.3 認知 (awareness) 7.4 溝通 (communication) 7.5 文件化資訊 (documented information) 7.5.1 概述 (general) 7.5.2 創建及更新 (creating and updating) 7.5.3 文件化資訊之控制 (control of documented information)	7.1 資源 (resources) 7.1.1 概述 (general) 7.1.2 基礎設施 (infrastructure 7.1.3 過程環境 (process environment) 7.1.4 監視及量測裝置 (monitoring and measuring devices) 7.1.5 知識 (knowledge) 7.2 職能 (competence) 7.3 認知 (awareness) 7.4 溝通 (communication) 7.5 文件化資訊 (documented information) 7.5.1 概述 (general) 7.5.2 創建及更新 (creating and updating) 7.5.3 文件化資訊之控制 (control of documented information)	7.1 資源 (resources) 7.1.1 概述 (general) 7.1.2 人員 (people) 7.1.3 基礎設施 (infrastructure) 7.1.4 過程運作之環境 (environment for the operation of process) 7.1.5 監視及量測資源 (monitoring and measuring resources) 7.1.6 組織知識 (organizational knowledge) 7.2 職能 (competence) 7.3 認知 (awareness) 7.4 溝通 (communication) 7.5 文件化資訊 (documented information) 7.5.1 概述 (general) 7.5.2 創建及更新 (creating and updating) 7.5.3 文件化資訊之控制 (control of documented information)	7.1 資源 (resources) 7.1.1 概述 (general) 7.1.2 人員 (people) 7.1.3 基礎設施 (infrastructure) 7.1.4 過程運作之環境 (environment for the operation of process) 7.1.5 監視及量測資源 (monitoring and measuring resources) 7.1.6 組織知識 (organizational knowledge) 7.2 職能 (competence) 7.3 認知 (awareness) 7.4 溝通 (communication) 7.5 文件化資訊 (documented information) 7.5.1 概述 (general) 7.5.2 創建及更新 (creating and updating) 7.5.3 文件化資訊之控制 (control of documented information)
8. 運作 (operation)	8. 運作 (operation)	8. 運作 (operation)	8. 運作 (operation)
8.1 運作規劃與控制 (operational planning and control) 8.2 與顧客及其他相有興趣團體之互動 (interaction with customers and other interested parties) 8.2.1 與產品相關要求之決定 (determination of requirements related to the product) 8.2.2 與產品相關要求之審查 (review of requirements related to the product) 8.2.3 顧客溝通 (customer communication) 8.3 運作準備 (operational preparedness) 8.4 外部過程或產品之控制 (control of external processes or product) 8.5 設計與發展 (design and development) 8.5.1 定義 (define) 8.5.2 分析 (analyze) 8.5.3 實現 (implement) 8.5.4 查證與確認 (verify and validate) 8.5.5 轉移至運作 (transfer to operation) 8.6 執行/實現 (execution/implementation) 8.6.1 生產與服務提供之控制 (control of production and service provision) 8.6.2 生產與服務提供過程之確認 (validation of processes for production and service provision) 8.6.3 識別及追溯性 (identification and traceability) 8.6.4 產品之監視與量測 (monitoring and measurement of product) 8.6.5 不符合產品之控制 (control of nonconforming product) 8.6.6 屬於外部團體之財產 (property belonging to external parties) 8.6.7 產品之保存 (preservation of product) 8.6.8 交付後作業 (post delivery activities)	8.1 運作規劃及控制 (operational planning and control) 8.2 市場需要及與顧客互動之決定 (determination of market needs and interactions with customers) 8.2.1 概述 (general) 8.2.2 商品與服務相關要求之決定 (determination of requirements related to the goods and services) 8.2.3 商品與服務相關要求之審查 (review of requirements related to goods and services) 8.2.4 顧客溝通 (customer communication) 8.3 運作規劃過程 (operational planning process) 8.4 外部提供商品與服務之控制 (control of external provision of goods and services) 8.4.1 概述 (general) 8.4.2 外部提供控制之種類與程度 (type and extent of control of external provision) 8.4.3 外部提供者之文件化資訊 (documented information for external providers) 8.5 商品與服務之發展 (development of goods and services) 8.5.1 發展過程 (development processes) 8.5.2 發展控制 (development controls) 8.5.3 發展轉移 (development transfer) 8.6 商品生產及服務提供 (production of goods and provision of services) 8.6.1 商品生產與服務提供之控制 (control of production of goods and provision of services) 8.6.2 識別及追溯性 (identification and traceability) 8.6.3 屬於顧客或外部提供者之財產 (property belonging to customer or external providers) 8.6.4 商品或服務之保存 (preservation of goods or services) 8.6.5 交付後作業 (post delivery activities 8.6.6 變更之控制 (control of changes) 8.7 商品與服務之發佈 (release of goods and services) 8.8 不符合商品與服務 (nonconforming goods and services)	8.1 運作規劃及控制 (operational planning and control) 8.2 產品與服務要求之決定 (determination of requirements for products and services) 8.2.1 顧客溝通 (customer communication) 8.2.2 產品與服務相關要求之決定 (determination of requirements related to products and services) 8.2.3 產品與服務相關要求之審查 (review of requirements related to products and services) 8.3 產品與服務之設計與發展 (design and development of products and services) 8.3.1 概述 (general) 8.3.2 設計與發展規劃 (design and development planning) 8.3.3 設計與發展輸入 (design and development inputs) 8.3.4 設計與發展控制 (design and development controls) 8.3.5 設計與發展輸出 (design and development outputs) 8.3.6 設計與發展變更 (design and development changes) 8.4 外部提供產品與服務之控制 (control of externally provided products and services) 8.4.1 概述 (general) 8.4.2 外部提供控制之種類與程度 (type and extent of control of external provision) 8.4.3 外部提供者之資訊 (information for external providers) 8.5 生產與服務提供 (production and service provision) 8.5.1 生產與服務提供之控制 (control of production and service provision) 8.5.2 識別及追溯性 (identification and traceability) 8.5.3 屬於顧客或外部提供者之財產 (property belonging to customers or external providers) 8.5.4 保存 (preservation) 8.5.5 交付後作業 (post-delivery activities) 8.5.6 變更控制 (control of change) 8.6 產品與服務之發佈 (release of products and services) 8.7 不符合過程輸出、產品與服務之控制 (control of nonconforming process outputs, products and services)	8.1 運作規劃及控制 (operational planning and control) 8.2 產品與服務要求之決定 (determination of requirements for products and services) 8.2.1 顧客溝通 (customer communication) 8.2.2 決定產品與服務要求 (determining the requirements for products and services) 8.2.3 產品與服務要求之審查 (review of requirements related to products and services) 8.2.4 產品與服務要求變更 (changes to requirements for products and services) 8.3 產品與服務之設計與發展 (design and development of products and services) 8.3.1 概述 (general) 8.3.2 設計與發展規劃 (design and development planning) 8.3.3 設計與發展輸入 (design and development inputs) 8.3.4 設計與發展控制 (design and development controls) 8.3.5 設計與發展輸出 (design and development outputs) 8.3.6 設計與發展變更 (design and development changes) 8.4 外部提供產品、過程與服務之控制 (control of externally provided processes, products and services) 8.4.1 概述 (general) 8.4.2 控制之種類與程度 (type and extent of control) 8.4.3 外部提供者之資訊 (information for external providers) 8.5 生產與服務提供 (production and service provision) 8.5.1 生產與服務提供之控制 (control of production and service provision) 8.5.2 識別及追溯性 (identification and traceability) 8.5.3 屬於顧客或外部提供者之財產 (property belonging to customers or external providers) 8.5.4 保存 (preservation) 8.5.5 交付後作業 (post-delivery activities) 8.5.6 變更控制 (control of change) 8.6 產品與服務之發佈 (release of products and services) 8.7 不符合過程輸出控制 (control of nonconforming outputs)
9. 績效評估 (performance evalution)	9. 績效評估 (performance evaluation)	9. 績效評估 (performance evaluation)	9. 績效評估 (performance evaluation)
9.1 監視、量測、分析與評估 (monitoring, measurement, analysis and evaluation) 9.1.1 概述 (general) 9.1.2 顧客滿意度 (customer satisfaction) 9.1.3 資料分析 (analysis of data) 9.2 內部稽核 (internal audit) 9.3 管理審查 (management review)	9.1 監視、量測、分析與評估 (monitoring, measurement, analysis and evaluation) 9.1.1 概述 (general) 9.1.2 顧客滿意度 (customer satisfaction) 9.1.3 資料分析與評估 (analysis and evaluation of data) 9.2 內部稽核 (internal audit) 9.3 管理審查 (management review)	9.1 監視、量測、分析與評估 (monitoring, measurement, analysis and evaluation) 9.1.1 概述 (general) 9.1.2 顧客滿意度 (customer satisfaction) 9.1.3 分析與評估 (analysis and evaluation) 9.2 內部稽核 (internal audit) 9.3 管理審查 (management review)	9.1 監視、量測、分析與評估 (monitoring, measurement, analysis and evaluation) 9.1.1 概述 (general) 9.1.2 顧客滿意度 (customer satisfaction) 9.1.3 分析與評估 (analysis and evaluation) 9.2 內部稽核 (internal audit) 9.3 管理審查 (management review) 9.3.1 概述 (general) 9.3.2 管理審查輸入 (management review inputs) 9.3.3 管理審查輸出 (management review outputs)
10. 改進 (improvement)	10. 改進 (improvement)	10. 改進 (improvement)	10. 改進 (improvement)
10.1 不符合及改正行動 (nonconformity and cotrective action) 10.2 持續改進 (continual improvement)	10.1 不符合及改正行動 (nonconformity and corrective actions) 10.2 改進 (improvement)	10.1 概述 (general) 10.2 不符合性及改正行動 (nonconformity and corrective action) 10.3 持續改進 (continual improvement)	10.1 概述 (general) 10.2 不符合性及改正行動 (nonconformity and corrective action) 10.3 持續改進 (continual improvement)
(秘書處：必要時待發展)	附錄 A (參考) 品質管理原則 (quality management principles) A.1 簡介 (introduction) A.2 QM1：顧客聚焦 (customer focus) A.3 QM2：領導 (leadership) A.4 QM3：人員融入 (engagement of people) A.5 QM 4：過程方式 (process approach) A.6 QM 5：改進 (improvement) A.7 QM 6：基於證據之決策制訂 (evidence-based decision making) A.8 QM 7：關係管理 (relationship management)	附錄 A (參考) 新架構、名詞與觀念之澄清 (clarification of new structure, terminology and concepts) A.1 架構與名詞 (structure and terminology) A.2 產品與服務 (products and services) A.3 組織之情境 (context of the organization) A.4 基於風險方式 (risk-based approach) A.5 應用性 (applicability) A.6 文件化資訊 (documented information) A.7 組織知識 (organizational knowledge) A.8 外部提供產品與服務之控制 (control of externally provided products and services)	附錄 A (參考) 新架構、名詞與觀念之澄清 (clarification of new structure, terminology and concepts)
		附錄 B (參考) 品質管理原則 (quality management priciples) B.1 簡介 (introduction) B.2 QM1：顧客聚焦 (customer focus) B.2 QM2：領導(leadership) B.3 QM3：人員許諾(或融入)註(engagement of people) B.4 QM4：過程方式 (process approach) B.5 QM5：改進 (improvement) B.6 QM6：以證據為基礎決策制訂 (evidence-based decision making) B.7 QM7：關係管理 (relationship management)	附錄 B (參考) ISO/TC 176 發展有關品質管理與品質管理系統之其他國際標準 (other International Standards on quality management and quality management systems developed by ISO/TC 176)
		附錄 C (參考) 品質管理標準 ISO 10000 組合 (the ISO 10000 portfolio of quality management standards)
參考書目 Bibliography	參考書目 Bibliography	參考書目 Bibliography	參考書目 Bibliography

修改紀錄：

• 20140731，林公建議將 "engagement" 翻譯為許諾，亦可譯為融入或投入，強調與原先參與 (participate) 之區別。
• 20170906，"context" 原翻譯為「情境」，為了和 "situation" 有所區別，context 翻譯為「情景」、situation 翻譯為「情境」。
• 20170906，"normative references" 原翻譯為「正式引用文件」，改翻譯為「規範性引用文件」，相對應在附錄常見的 "informative" 翻譯為「資訊性」。
  

參考資料：

• ISO 9001 Revision
  

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比較 2008 年與 2014 年的品質管理系統，兩者都是基於過程的品質管理系統，但是 2014 年 DIS 版在概念上有所調整。一般過程是由輸入 (input)、過程 (process)、輸出 (output) 所構成，稱為 "IPO" 三個要素，所謂「基於過程品質管理系統」的過程，指的是提供給顧客的產品與服務的過程，其輸入(I)為：要求（來自顧客及其他相關有興趣團體）、過程 (P) 為：運作過程、輸出 (O) 為：產品與服務（符合顧客滿意度）。品質管理系統(第 4.4 節)由領導(第 5 章)、規劃 (第 6 章)、運作(第 8 章)及績效評估(第 9 章)四個部分所構成，這四部分並形成一個循環。
資源管理改為支援(第 7 章)過程，放在提供產品與服務的 IPO 流程及管理循環之外。


ISO 9001:2015版第 0 章「簡介」、第0.3 節「過程方式」(0.3 Process approach)，說明基於過程品質管理系統模型的概念。


Figure 1 -
資料來源：ISO/DIS 9001:2014

2014年版簡介第0.3 節中的Figure 1，顯示 ISO 9001:2015 第 4 章至第10章之間的關係，表示品質管理系統是一個基於過程的品質管理系統模型(model of process-based quality management system)。

2014年版的品質管理系統(QMS)，以組織之情境(第 4 章)為背景、以過程為基礎，輸入由顧客擴充為顧客及其他相關有興趣團體之要求，輸出為符合顧客滿意度的產品與服務，並作為品質管理系統持續改進(第10章)的回饋輸入。過程部分包括管理循環過程與支援過程(第7章)，管理循環過程為連結輸入和輸出的運作過程(第8章、加上領導(第5章)、規劃(第6章)及績效評估(第9章)三過程，領導、規劃、運作及績效評估四個過程形成品質管理系統的循環。


ISO 9004:2009 簡介


Figure 1 - Extended model of a process-based quality management system
資料來源: ISO 9004:2009


ISO 9001:2008第四版，第 0 章、第 0.2 節「過程方式」(process approach)，說明基於過程品質管理系統模型的概念

Figure 1 -
資料來源：ISO 9001:2008

Figure 1 - 基於過程品質管理系統模型(Model of a  process-based quality management system)．說明 ISO 9001:2008 第 4 章至第 8 章之間的關係。2008年的品質管理系統是以過程為基礎，輸入為顧客要求，輸出為顧客滿意度及品質管理系統的持續改進，過程包括管理職責、資源管理、產品實現何量測分析與改進四個部分，這四個過程形成一個循環。

0.3 過程方式(Process approach)

Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.  This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.  Clause 4.4 of this International Standard includes specific requirements considered essential to the adoption of a process approach.  

The process approach applies systematic definition and management of processes and their interactions so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using a “Plan-Do-Check-Act” (PDCA) methodology (see 0.4) with an overall focus on “Risk-based thinking” aimed at preventing undesirable outcomes (see 0.5).  

When used within a quality management system, the process approach ensures:

a) understanding and consistently meeting requirements;

b) consideration of processes in terms of added value;

c) the achievement of effective process performance;

d) improvement of processes based on evaluation of data and information.  

Figure 1 illustrates the process linkages between clauses 4 to 10 of this International Standard.  This shows that customers play a significant role in defining the input requirements that the organization needs to meet at all stages of its quality management system. In addition, the needs and expectations of other relevant interested parties can also play a role in defining those requirements.  Monitoring of customer satisfaction requires the evaluation of information relating to customer perceptions as to whether the organization has met these requirements.

The schematic model shown in Figure 1 covers all the requirements of this International Standard, but does not show the individual processes at a detailed level. Each of these processes, and the system as a whole, can be managed using the PDCA methodology described in clause 0.4 of this International Standard.  

Figure 1 -

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第 0 章簡介、第0.4節「規劃-執行-檢核-行動」循環
P-D-C-A方法可以應用到品質管理系統的所有過程。

戴明PDCA(Plan, Do, Check, and Act)循環，在2000年版及2008年版是放在0.2 過程方式的註釋，2015年版提升為本文第0.4節。大致的精神維持著，只是在一些細節方面做了更明確的定義。其中比較有趣的是，在規劃時，加入必要的資源，這是管理階層的職責，否則巧婦難為無米之炊；執行所規劃的事務，而不只是過程本身；檢核時，量測部分增加適用時(when applicable)的彈性註釋，強調實務上並不是所有項目都是可量測的，雖然這是極致的目標；行動部分，則維持2015年的原企圖取消連續一詞，另外採取行動增加視需要(as necessary)的彈性，就好像有人(忘了是誰)對PDCA四個字所提出的新解「不要變更任何東西」" Please Don't Change Anything"一樣。


ISO 9001:2000 & ISO 9001:2008
0.2 Process approach
...
NOTE.  In addition, the methodology known as "Plan-Do-Check-Act" (PDCA) can be applied to all processes.  PDCA can be briefly described as follows.  
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
Act: take actions to coninually improve process performance.  


ISO/DIS 9001:2015 (2014)
0.4 Plan-Do-Check-Act cycle

The methodology known as "Plan-Do-Check-Act" (PDCA) can be applied to all processes and to the quality management system as a whole.  The clauses of this International Standard broadly follow the PDCA cycle which can be briefly decribed as follows:
- Plan: establish the objectives of the system and its component processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies.
- Do: implement what was planned.
- Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements, and report the results.
- Act: take actions to improve process performance, as necessary.  

Figure 2 shows schematically how a single process within the quality management system can be managed using the PDCA cycle.



資料來源：ISO/DIS 9001:2014
Figure 2 - Schematic representation of a single process within the system

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ISO 9001:2015 DIS 版第 0.2 節「ISO 品質管理標準」在 FDIS 改版時刪除，相關內容資料移到附錄 B ，（亦即 DIS 版的 附錄 C）。FDIS 版的 表 B.1 （如下）或 DIS 版的表 C.1 提供不錯的對照關係。由於版本內容不同， FDIS B.1 與 DIS C.1 引述的章節編號有些不同。 2016 年發布的國際標準正式板維持 FDIS 版的內容。


ISO 9001:2015 國際標準版附錄 B 表 B.1

ISO 9001:2015 FDIS 附錄 B 表 B.1

source: ISO 9001:2015 FDIS

ISO 品質管理標準包括 ISO 9000 系列的核心標準 (core standards) 及 ISO 10000 系列的支援標準 (support standards) 兩大部分。

ISO 9000 系列核心標準 (core standards)

• ISO 9000《品質管理系統 - 基本原理及詞彙》(Quality management systems - Fundamentals and vocabulary)
• ISO 9001《品質管理系統 - 要求》(Quality management systems - Requirements)
• ISO 9004《管理組織永續成功》(Managing for the sustained success of an organization)
  

ISO 10000 系列支援標準(supporting standards)(詳見附錄C)

• ISO 10001《品質管理 - 顧客滿意度 - 組織行為守則指導綱要》(Quality management - Customer satisfaction – Guidelines for codes of conduct for organizations)
• ISO 10002《品質管理 - 顧客滿意度 - 組織抱怨處理指導綱要》(Quality management – Customer satisfaction – Guidelines for complaints handling in organizations)
• ISO 10003《品質管理 - 顧客滿意度 - 組織外部爭議解決指導綱要》(Quality management – Customer satisfaction – Guidelines for dispute resolution in organizations)
• ISO 10004《品質管理 - 顧客滿意度 - 監視與量測指導綱要》(Quality management – Customer satisfaction – Guidelines for monitoring and measuring equipment)
• ISO 10005《品質管理系統 - 品質計畫書指導綱要》(Quality management – Guidelines for quality plans)
• ISO 10006《品質管理系統 - 專案品質管理指導綱要》(Quality management – Guidelines for quality management in projects)
• ISO 10007《品質管理系統 - 形態管理》(Quality management – Guidelines for configuration management)
• ISO 10008《品質管理 - 顧客滿意度 - 企業對消費者電子商務交易指導綱要》
• ISO 10012《量測管理系統 - 量測過程與量測設備要求》(Measurement management systems – Requirements for measurement processes and measuring equipment)
• ISO/TR 10013《品質管理系統文件指導綱要》(Guidelines for quality management system documentation)
• ISO 10014《品質管理 - 實現財務與經濟利益指導綱要》(Quality management – Guidelines for realizing financial and economic benefits)
• ISO 10015《品質管理 - 訓練指導綱要》(Quality management – Guidelines for training)
• ISO/TR 10017《ISO 9001:2000 統計技法指南》(Guidance on statistical techniques for ISO 9001:2000)
• ISO 10018《品質管理 - 人員參與及職能指導綱要》(Quality management – Guidelines on people involvement and competences)
• ISO 10019《選擇品質管理系統顧問及使用其服務指導綱要》(Guidelines for the selection of quality management system consultant and use of their services)
• ISO 19011《稽核管理系統指導綱要》(Guidelines for quality and/or environmental management systems auditing)
  

參考資料：

• ISO 9001:2015
• ISO 9001:2015 FDIS
• ISO 9001:2015 DIS
  

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FDIS 版將 DIS 版第 3 章的內容簡化，相關資料移到 ISO 9000:2015，這樣處理符合單一表述、其餘引述的原則，避免後續文件變更時掛一漏萬情事發生，符合文件管理基本原則。正式版維持 FDIS 的建議。
"For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply."

第 3 章為品質管理系統相關的名詞與定義，DIS 版總共有 69 個名詞與定義，比附錄 SL 《管理系統標準高階架構》 (HLS) 的 22 個名詞還要多出好幾倍（多出 47 個）。這 69 個名詞與定義除了少數修改之外，幾乎完全引用並重複敘述 ISO/DIS 9000:2014 的內容，這點與一般標準文件對於相同資訊，採取引用專業文件而不重複敘述的模組化原則不同， ISO 9000:2015 FDIS 發行時，已經將之移除。原先在 DIS 發行時，所產生會不會再有變化的疑慮，確認 ISO 技委已做處理。如此改版過成文件維持詳細內容，正式版本清稿時予以刪除，留下處理過程軌跡資料的作法，對於專業的追溯性與傳承性有很大的幫助。

利害相關者 (stakeholder) 在 CD 版時與有興趣團體 (interested parties) 並列，只是有興確團體標註為優先使用名詞 (preferred term)、而利害相關者為承認名詞 (admitted term)，不過在 DIS 版時則刪除不再並列使用。

工作小組版(WD)、委員會版 (CD) 及國際標準草稿版 (DIS) 名詞與定義之差異比較如下表所示：

WD、CD、DIS 版名詞與定義比較
ISO/WD 9001:2012	ISO/CD 9001:2013	ISO/DIS 9001:2014
3.01 組織 organization	3.01 組織 organization	3.01 組織 organization ISO/DIS 9000:2014, 3.2.1
3.02 有興趣團體 interested parties	3.02 有興趣團體 interested parties 利害相關者 stakeholder	3.02 有興趣團體 interested parties ISO/DIS 9000:2014, 3.2.4
3.03 要求 requirement	3.03 要求 requirement	3.03 要求 requirement ISO/DIS 9000:2014, 3.5.4
3.04 管理系統 management system	3.04 管理系統 management system	3.04 管理系統 management system ISO/DIS 9000:2014, 3.4.2.1
3.05 高層管理 top management	3.05 高層管理 top management	3.05 高層管理 top management ISO/DIS 9000:2014, 3.1.1
3.06 有效性 effectiveness	3.06 有效性 effectiveness	3.06 有效性 effectiveness ISO/DIS 9000:2014, 3.7.7
3.07 政策 policy	3.07 政策 policy	3.07 政策 policy ISO/DIS 9000:2014, 3.4.5
3.08 目標 objective	3.08 目標 objective	3.08 目標 objective ISO/DIS 9000:2014, 3.7.1
3.09 風險 risk	3.09 風險 risk	3.09 風險 risk ISO/DIS 9000:2014, 3.7.4
3.10 職能 competence	3.10 職能 competence	3.10 職能 competence ISO/DIS 9000:2014, 3.6.6
3.11 文件化資訊 documented information	3.11 文件化資訊 documented information	3.11 文件化資訊 documented information ISO/DIS 9000:2014, 3.8.1.1.1
3.12 過程 process	3.12 過程 process	3.12 過程 process ISO/DIS 9000:2014, 3.6.1
3.13 績效 performance	3.13 績效 performance	3.13 績效 performance ISO/DIS 9000:2014, 3.7.5
3.14 委外(動詞) outsource	3.14 委外(動詞) outsource	3.14 委外(動詞) outsource ISO/DIS 9000:2014, 3.6.3
3.15 監視 monitoring	3.15 監視 monitoring	3.15 監視 monitoring ISO/DIS 9000:2014, 3.13.1.2
3.16 量測 measurement	3.16 量測 measurement	3.16 量測 measurement ISO/DIS 9000:2014, 3.13.3
3.17 稽核 audit	3.17 稽核 audit	3.17 稽核 audit ISO/DIS 9000:2014, 3.10.1 mod
3.18 符合性 conformity	3.18 符合性 conformity	3.18 符合性 conformity ISO/DIS 9000:2014, 3.5.6
3.19 不符合性 nonconformity	3.19 不符合性 nonconformity	3.19 不符合性 nonconformity ISO/DIS 9000:2014, 3.5.5
3.20 改正 correction	3.20 改正 correction	3.20 改正行動 corrective action ISO/DIS 9000:2014, 3.11.2
3.21 改正行動 corrective action	3.21 改正行動 corrective action	3.21 持續改進 continual improvement
3.22 持續改進 continual improvement	3.22 持續改進 continual improvement	3.22 改正 correction ISO/DIS 9000:2014, 3.11.3
		3.23 參與 imvolvement ISO 10018:2012, 3.5
		3.24 組織內涵 context of the organization ISO/DIS 9000:2014, 3.2.3
		3.25 機能（功能） function ISO/DIS 9000:2014, 3.2.5
		3.26 顧客 customer ISO/DIS 9000:2014, 3.2.6
		3.27 供應者、提供者 supplier, provider ISO/DIS 9000:2014, 3.2.7
		3.28 改進 improvement ISO/DIS 9000:2014, 3.3.1
		3.29 管理 management ISO/DIS 9000:2014, 3.3.2
		3.30 品質管理 quality management ISO/DIS 9000:2014, 3.3.2.1
		3.31 系統 system ISO/DIS 9000:2014, 3.4.1
		3.32 基礎建設 infrastructure
		3.33 品質管理系統 quality management system ISO/DIS 9000:2014, 3.4.1.2.1
		3.34 品質政策 quality policy ISO/DIS 9000:2014, 3.4.5.1
		3.35 策略 strategy ISO/DIS 9000:2014, 3.4.8
		3.36 物件 object ISO 1087-1:2000, ISO/DIS 9000:2014, 3.5.1
		3.37 品質 quality ISO/DIS 9000:2014, 3.5.2
		3.38 法令要求 statutory requirement ISO/DIS 9000:2014, 3.5.4.2
		3.39 規章要求 requlatory requirement ISO/DIS 9000:2014, 3.5.4.3
		3.40 瑕疵 defect ISO/DIS 9000:2014, 3.5.5.1
		3.41 追溯性 traceability ISO/DIS 9000:2014, 3.5.8
		3.42 創新 innovation ISO/DIS 9000:2014, 3.6.1.2
		3.43 合約 contract ISO/DIS 9000:2014, 3.6.4
		3.44 設計與發展 design and development ISO/DIS 9000:2014, 3.6.5
		3.45 品質目標 quality objective ISO/DIS 9000:2014, 3.7.1.1
		3.46 輸出 output ISO/DIS 9000:2014, 3.7.3
		3.47 產品 product ISO/DIS 9000:2014, 3.7.3.1 mod
		3.48 服務 service ISO/DIS 9000:2014, 3.7.3.2
		3.49 資料 data ISO/DIS 9000:2014, 3.8.1
		3.50 資訊 information ISO/DIS 9000:2014, 3.8.1.1
		3.51 客觀證據 objective evidence ISO/DIS 9000:2014, 3.8.1.2
		3.52 資訊系統 information system ISO/DIS 9000:2014, 3.8.2
		3.53 知識 knowledge ISO/DIS 9000:2014, 3.8.3
		3.54 查證 verification ISO/DIS 9000:2014, 3.8.5 mod
		3.55 確認 validation ISO/DIS 9000:2014, 3.8.6 mod
		3.56 回饋 feedback ISO/DIS 9000:2014, 3.9.2
		3.57 顧客滿意度 customer satisfaction ISO/DIS 9000:2014, 3.9.3
		3.58 抱怨 complaint ISO/DIS 9000:2014, 3.9.4
		3.59 稽核方案 audit programme ISO/DIS 9000:2014, 3.10.9
		3.60 稽核準則 audit criteria ISO/DIS 9000:2014, 3.10.12 mod
		3.61 目標/稽核證據 objective/audit evidence ISO/DIS 9000:2014, 3.10.13
		3.62 稽核發現 audit findings ISO/DIS 9000:2014, 3.10.14
		3.63 特許 concession ISO/DIS 9000:2014, 3.11.5
		3.64 發行 release ISO/DIS 9000:2014, 3.11.7
		3.65 特性 characteristic ISO/DIS 9000:2014, 3.12.1
		3.66 績效指標 performance indicator ISO/DIS 9000:2014, 3.12.1.2
		3.67 決定 determination ISO/DIS 9000:2014, 3.13.1
		3.68 審查 review ISO/DIS 9000:2014, 3.13.1.1
		3.69 量測試驗 measuring equipment ISO/DIS 9000:2014, 3.13.5

hlperng

2015 年 ISO 9001 國際標準版除了兩個網站連結之外，又增加一份參考書目（第 27 項），總共 29 項：
27. Integrated use of management system standards, ISO
28. www.iso.org/tc176/sc02/public
29. www.iso.org/tc176/ISO9001AuditingPracticesGroup

相對於2014 年的 DIS 版，FDIS 版的「參考書目」新增兩個國際標準化組織 (ISO) 品質管理技術委員會 (ISO/TC176) 的網路連結，其餘同 DIS 版。
27. www.iso.org/tc176/sc02/public
28. www.iso.org/tc176/ISO9001AuditingPracticesGroup

ISO/DIS 9001:2014 最後附加的參考書目總共有 26 項，其最新版本之年份以紅色加註於標準的文件編號之後，以供參考。相對於此次的修訂版，2008年版的參考書目有 23 項、2000 年版本有 19 項。
在參考書目引用的文件，其中相關的管理系統包括：

• 專案管理 (ISO 10006)
• 型態管理 (ISO 10007)
• 環境管理 (ISO 14001)
• 軟體工程品質管理 (ISO 90003) (上一版為ISO 9000-3:1997)
• 可恃性管理 (IEC 60300-1:2003) (上一版為ISO 9000-4:1993=IEC 60300-1:1993)
  

對於電子產品而言，ISO 90003:2008《軟體工程品質管理》及IEC 60300-1:2003《可恃性管理》（可恃性為廣義的可靠度）是不可忽視的部分，但是自從 2000 年版從 ISO 9001 版本脫鉤，不再狹義的 ISO 9000 標準家族之後，似乎很少人重視其重要性。

• ISO 9000:2013, Quality managment systems - Fundamentals and vocabulary
• ISO 9004:2008, Managing for the sustained success of an organization - A quality management approach
• ISO 10001:2007, Quality management - Customer satisfaction - Guidelines for codes of conduct for organization
• ISO 10002:2004, Quality management - Customer satisfaction - Guidelines for complaints handling in organization
• ISO 10003:2007, Quality management - Customer satisfaction - Guidelines for dispute resolution external to organization
• ISO 10004:2012, Quality management - Customer satisfaction - Guidelines for monitoring and measuring
• ISO 10005:2005, Quality management systems - Guidelines for quality plans
• ISO 10006:2003, Quality management systems - Guidelines for quality management in projects
• ISO 10007:2003, Quality management systems - Guidelines for configuration management
• ISO 10008:2013, Quality management - Customer satisfaction - Guidelines for business-to-consumer electronic commerce transactions
• ISO 10012:2003, Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO/TR 10013:2001, Guidelines for quality management system documentation
• ISO 10014:2006, Quality management - Guidelines for realizing financial and economic benefits
• ISO 10015:1999, Quality management - Guidelines for training
• ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000
• ISO 10018:2012, Quality management - Guidelines on people involvement and competence
• ISO 10019:2005, Guidelines for the selection of quality management system consultants and use of their services
• ISO 14001:2004, Environmental management systems - Requirements with guidance for use
• ISO 19011:2011, Guidelines for auditing management systems
• ISO/DIS 37500:2013, Guidance on outsourcing
• IEC 60300-1:2003, Dependability management - Part 1: Dependability management systems
• IEC 61160:2005, Design review
• ISO/IEC 90003:2008, Software engineering - Guidelines for the application of ISO 9001:2000 to computer software
• Quality management priciples, ISO
• Selection and use of the ISO 9000 family of standard, ISO
• ISO 9001 for Small Businesses - What to do, ISO
• Integrated use of management system standards, ISO
• www.iso.org/tc176/sc02/public
• www.iso.org/tc176/ISO9001AuditingPracticesGroup
  

比較 ISO 9001 2015 DIS 版、2008 年版及2000 年版的參考書目如下表所示：

ISO 9001:2015 (29 項)	ISO 9001:2015 FDIS (28 項)	ISO 9001:2015 DIS (26 項)	ISO 9001:2008 (23 項)	ISO 9001:2000 (19 項)
1.  ISO 9004	1. ISO 9004	1. ISO 9000	--	--
2. ISO 10001	2. ISO 10001	2. ISO 9004	1. ISO 9004:-	2. ISO 9004:2000
3. ISO 10002	3. ISO 10002	3. ISO 10001	2. ISO 10001:2007	--
4. ISO 10003	4. ISO 10003	4. ISO 10002	3. ISO 10002:2004	--
5. ISO 10004	5. ISO 10004	5. ISO 10003	4. ISO 10003:2007	--
6. ISO 10005	6. ISO 10005	6. ISO 10004	--	--
7. ISO 10006	7. ISO 10006	7. ISO 10005	5. ISO 10005:2005	3. ISO 10005:1995
8. ISO 10007	8. ISO 10007	8. ISO 10006	6. ISO 10006:2003	4. ISO 10006:1997
9. ISO 10008	9. ISO 10008	9. ISO 10007	7. ISO 10007:2003	5. ISO 10007:1995
10. ISO 10012	10. ISO 10012	10. ISO 10008	--	--
11. ISO 10013	11. ISO 10013	11. ISO 10012	8. ISO 10012:2003	9. ISO 10012-1:1992 10. ISO 10012-2:1997
12. ISO 10014	12. ISO 10014	12. ISO 10013	9. ISO 10013:2001	11. ISO 10013:1995
13. ISO 10015	13. ISO 10015	13. ISO 10014	10. ISO 10014:2006	12. ISO 10014:1998
14. ISO 10017	14. ISO 10017	14. ISO 10015	11. ISO 10015:1999	13. ISO 10015:1999
15. ISO 10018	15. ISO 10018	15. ISO 10017	12. ISO 10017:2003	14. ISO 10017:1999
16. ISO 10019	16. ISO 10019	16. ISO 10018	--	--
17. ISO 14001	17. ISO 14001	17. ISO 10019	13. ISO 10019:2005	--
18. ISO 19011	18. ISO 19011	18. ISO 14001	14. ISO 14001:2004	15. ISO 14001:1996
19. ISO 31000	19. ISO 31000	19. ISO 19011	15. ISO 19011:2002	6. ISO 10011-1:1990 7. ISO 10011-2:1991 8. ISO 10011-3:1991
20. ISO 37500	20. ISO 37500	20. ISO 37500	--	--
21. ISO 90003	21. ISO 90003	21. IEC 60300-1	16. IEC 60300-1:2003	16. IEC 60300-1:-
22. IEC 60300-1	22. IEC 60300-1	22. IEC 61160	17. IEC 61160:2006	--
23. IEC 61160	23. IEC 61160	23. ISO 90003	18. ISO 90003:2004	1. ISO 9000-3:1997
24. Quality management principles	24. Quality management principles	24. Quality management principles	19. Quality managment priniciples, 2001	17. Quality managment principles brochure
25. Selection and use of the ISO 9000 family of standards, ISO	25. Selection and use of the ISO 9000 family of standards, ISO	25. Selection and use of the ISO 9000 familty of standards, ISO	20. ISO 9000 - Selection and use, 2008	--
26. ISO 9001 for Small Business - What to do, ISO	26. ISO 9001 for Small Businesses - What to do, ISO	26. ISO 9001 for Small Businesses - What to do, ISO	21. ISO for Small Businesses - What to do, 2002	--
27. Integrated use of managment system standards, ISO	27. www.iso/org/tc176/sc02/public		22. ISO Management systems	--
28. www.iso/org/tc176/sc02/public	28. www.iso.org/tc176/ISO9001AuditingPracticesGroup		23. Reference web sites	19. Reference web sites
29. www.iso.org/tc176/ISO9001AuditingPracticesGroup				18. ISO 9000 + ISO 14000 News

hlperng

新版 ISO 9001 第四章〈組織之情境〉為新的章節，分為 4 節：4.1「瞭解組織及其情境」、4.2「瞭解有興趣團體之需要及期望」、4.3「決定品質管理系統之範圍」、4.4「品質管理系統及其過程」。
有些單位在引介 2015 年版 ISO 9001 時，將此章的名稱 "context of the organization" 翻譯為「組織環境」。ISO 9001:2008 只強調組織環境的概念，在ISO 9004:2009 的圖 1，的確是以組織環境 (organization's environment) 來界定及說明品質管理系統的範圍。但是，ISO 在處理 MSS 時，已經明白定位管理系統的範圍，組織在乎的不應只是營業環境，還要包括組織文化等內部因子，以及組織運作的社經環境等外在因子，所以組織的系統包括系統內涵本身、邊界及環境。這也是 2015 版的品質管理八大原則取消系統方式變成品質管理七大原則的基本原因，因為品質管理系統本身就是系統，何須用系統方式來處理之。關於組織情境的定義，ISO 21500:2012《專案管理指引》圖1 或許是不錯的理解參考資料。ISO 9001:2015 要求，組織都必須識別、監視、與審查和組織的運作目的及策略方向有關的內部和外部議題，使品質管理系統可以影響預定的結果。
(請參閱：本論壇 ISO 21500:2012《專案管理指引》http://tw-redi.com/forum.php?mod=viewthread&tid=461&extra=page%3D1)

只是 "Context" 這個字在 CNS 處理等同國際標準的風險管理相關國家標準，CNS 14889:2012 (ISO Guide 73:2009 IDT)、CNS 31000:2013 (idt ISO 31000:2008) 及 CNS 31010:2012 (idt ISO 31010:2009) 時，已經將 context 翻譯為「前後環節」，在有些文件則翻譯為上下文。就中文而言，context 應該譯為 「情境」或內涵，不過情境還是比較貼切的用語，其範圍比內涵或環境的境界更廣。

另外第 4.4 節的最後一段條款，也隱含著將品質管理系統作業中，事前規劃的程序書 (procedures) 及事後結果的記錄 (records) 改為建檔資訊或文件化資訊 (documented information) 之後，兩者的區別是以必須「維持」(maintain) 的事前建檔或文件化資訊為程序書，必須「保存」(retain) 的事後建檔或文件化資訊為記錄。


以下為ISO 9001:2015 的條文，黑色為 MSS 規定的標準條文，紅色是 ISO 9001 特有新增或變更的條文：

4.1 瞭解組織及其情境 (Understanding the organization and its context)
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.  
The organization shall monitor and review the information about these external and internal issues.  
NOTE 1.  Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.  
NOTE 2.  Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.  

4.2 瞭解有興趣團體之需要及期望(Understanding the needs and expectations of interested parites)
Due to their impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.  
The organization shall monitor and review the information about these interested parties and their relevant requirements.

4.3 決定品質管理系統之範圍(Determining the scope of the quality management system)
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.  
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.  
Where a requirement of this International Standard within the determined scope can be applied, then it shall be applied by the organization.  
If any requirement(s) of this International Standard cannot be applied, this shall not affect the organization’s ability or responsibility to ensure conformity of products and services.
The scope shall be available and be maintained as documented information stating the:
- products and services covered by the quality management system;
- justification for any instance where a requirement of this International Standard cannot be applied.  

4.4 品質管理系統及其過程 (Quality management system and its processes)
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed the their interactions, in accordance with the requirements of this International Standard.  
The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaction of these processes;
c) the criteria, methods, including measurement and related performance indicators needed to ensure the effective operation, and control of these processes;
d) the resources needed and ensure their availability;
e) the assignment of the responsibilities and authorities for these processes;
f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;
g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results;
h) opportunities for improvement of the processes and the quality management system.  
The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.  

hlperng

持續不是連續或不斷，改進不只是改善，持續改進是改善。

2015 年 ISO 9001:2015 FDIS 版，除少數修正外，大致與 DIS 版類似，差異如下表所示。
2014 年 ISO 9001 的 DIS 版，第 10 章「改進」(Improvement)，包括 3 節，10.1 概述(general)、10.2 不符合性與改正行動(nonconformity and corrective actions)、10.3 持續改進 (continual improvement)。

此一章最大的意義在於「持續」 (continual) 與「改進」 (improvement) 兩個名詞的意義。
與 2008 年第四版相比較改變很大，2015 年版主要的重點有兩項，第一是點出章標題：改進 (improvement) 與第 3 節標題：「持續改進」或「時常改進」 (continual improvement)，兩者有大小範圍的差異，第二是取消過去大家已經習慣常用的「預防行動」(preventive action, PA) 與「改正行動」(corrective action, CA) 兩大改進法寶中的「預防行動」(PA)。

不過預防行動只是表面上被取消，取代之的是基於風險思維或風險為基思維 (risk-based thinking)。主要的觀念在於，當發現品質管理系統發生不符合情事時，就要馬上改進，若使用預防行動作為其手段，在觀念有可能會誤導到「改進的動作可以延到以後再說」的疑慮，這一點符合現代許多管理常採用的行動方式，那就是將過去的事先規劃的預防 (preventive)，改為較務實的預測 (predictive) 或互動或調適 (proactive or adaptive) 的趨勢。

至於改進與持續改進，首先應該了解英文 continual 一字的意義，continual 是指的持續、時常、常常發生，但是有開始有結束，反複不斷地頻繁的意思，而 continuous 則是連續不中斷、不停止。所以 continual improvement 是持續改進、continuous improvement 則是不斷改進。管理系統不可能一直再改變，因此可以想像，ISO 9001 使用使用較為嚴謹的 continual 而不是大家習慣常用的 continuous。中文翻譯為持續，因此可以稱 continual improvement 為持續改進，若是使用持續不斷改進或不斷改進，則會超過英文的原義。

有關改進 (improvement) 部分，可以從第 10.1 節第二段後面的注釋 (NOTE) 看出它的意義，FDIS 版與 DIS 版的內容分別為：
FDIS 版：「改進的範例可以包括改正（或矯正）、改正行動、持續改進、突破性變更、創新、與組織重整。」(Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.)
DIS 版：「改進效果的產生可以反應式（例如改正行動）、漸進式（例如持續改進）、階梯式變更（例如突破）、創造式（例如創新）、或藉由組織重整（例如轉變或轉型）。」(Improvement can be effected reactively (e.g., corrective action), incrementally (e.g., continual improvement), by step change (e.g., breakthrough), creatively (e.g., innovation) or by re-organization (e.g., transformation). )

改進與改善之區別，可能就要追溯到西方人對於改善 (Kaizen) 與改進 (improvement) 的看法。日本改善之父今井正明(Masaaki Imar) 先生 1997 指出，管理 (management) 有兩項功能，包括維持（或維護） (maintenance) 與改進 (improvement)。其中維護指的是維持現有技術、管理及運作標準有關的活動，以及透過訓練與紀律保持這些標準。改進 (improvement) 指的是提升現有（技術、管理及運作）標準有關的活動，又分為改善 (kaizen) 與創新 (innovation) 兩部分，亦即：改進 (Improvement) = 持續改進 (continual improvement) + 創新 (innovation)。

改善亦稱持續改進 (continual improvement, CI) 為小改進 (small improvements)，是一種持續的努力 = 現場改善 (Gemba Kaizen)

改善 (kai-zan) = Kai (change) + zen (for the better)

管理職能 = 維持 + 改進 = 維持 + 改善 + 創新 = 維持 + 持續改進 + 創新
管理手法 = 規劃 + 組織 + 分工 + 領導 + 統御

ISO/DIS 9001:2015 與 ISO/FDIS 9001:2015 第 10 章 內容比較
DIS (2015)	FDIS (2015)	注釋
10. Improvement	10. Improvement
10.1 General	10.1 General
The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction.	The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.	加了一個字any
This shall include, as appropriate: a) improving processes to prevent nonconformities; b) improving products and services to meet known and predicted requirements; c) improving quality management system results.	These shall include: a) improving products and services to meet requirements as well as to address future needs and expectations; b) correcting, preventing or reducting undersired effects; c) improving the performance and effectiveness of the quality management systems.	維持三項，但是內容大符調整。
NOTE.  Improvement can be effected reactively (e.g., corrective action), incrementally (e.g., continual improvement), by step change (e.g., breakthrough), creatively (e.g., innovation) or by re-organization (e.g., transformation).	NOTE.  Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.	文字內容改變。 原先使用形容詞、括號舉例名詞，改為只用名詞。
10.2 Nonconformity and corrective action	10.2 Nonconformity and corrective action	維持
10.2.1 When a nonconformity occurs, including those arising from complaints, the organization shall: a) react to the nonconformity and as applicable:     1) take action to control and correct it;     2) deal with the consequences; b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:     1) reviewing the nonconformity;     2) determining the causes of the nonconformity;     3) determining if similar nonconformities exist, or could potentially occur; c) implement any action needed; d) review the effectiveness of any corrective action taken; e) make changes to the quality management system, if necessary.   Corrective actions shall be appropriate to the effects of the nonconformities encountered.   NOTE 1.  In some instances, it can be impossible to eliminate the cause of a nonconformity.   NOTE 2.  Corrective action can reduce the likelihood of recurrence to an acceptable level.	10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall: a) react to the nonconformity and, as applicable:     1) take action to control and correct it;     2) deal with the consequences; b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:     1) reviewing and analyzing the nonconformity;     2) determining the causes of the nonconformity;     3) determining if similar nonconformities exist, or could potentially occur; c) implement any action needed; d) review the effectiveness of any corrective action taken; e) update risks and opportunities determined during planning, if necessary; f) make changes to the quality management system, if necessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered.	those 改成 any； 項目增加一項 (e) 風險與機會； 取消兩個注釋。
10.2.2 The organization shall retain documented information as evidence of: a) the nature of the nonconformities and any subsequent actions taken; b) the results of any corrective action.	10.2.2 The organization shall retain documented information as evidence of: a) the nature of the nonconformities and any subsequent actions taken; b) the results of any corrective action.	不變
10.3 Continual improvement The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.   The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.   Where applicable, the organization shall select and ultilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement.	10.3 Continual improvement The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.   The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.	取消第三段內容 (Where applicable ...)。

ISO 9001:2015 FDIS (2015)
10. Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.  
These shall include (as appropriate):
a) improving products and services to meet requirements as well as to address future needs and expectations;
b) correcting, preventing or reducting undersired effects;
c) improving the performance and effectiveness of the quality management systems.  
NOTE.  Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.  

10.2 Nonconformity and corrective action
10.2.1 When a nonconformity occurs, including any  (those) arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
    1) take action to control and correct it;
    2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
    1) reviewing and analyzing the nonconformity;
    2) determining the causes of the nonconformity;
    3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.  

10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.  

10.3 Continual improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.  
The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.  



ISO 9001:2015 DIS (2014)
ISO 9001:2015 DIS 版第 10 章，除明確定義為品質管理系統，增加第 1 節（Annex SL 只有兩節）概述，第 10.3 節（亦即 Annex SL 第 10.2 節）增加一段敘述之外（如紅字部分），其餘條款文字與 Annex SL 相同。
10.1 概述 (General)
The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction.  
This shall include, as appropriate:
a) improving processes to prevent nonconformities;
b) improving products and services to meet known and predicted requirements;
c) improving quality management system results.
NOTE.  Improvement can be effected reactively (e.g., corrective action), incrementally (e.g., continual improvement), by step change (e.g., breakthrough), creatively (e.g., innovation) or by re-organization (e.g., transformation).
注釋：達到改進效果可以是透過反應式（例如：改正行動）、漸進式（例如：持續改進）、階段變更式（例如：突破）、創造式（例如：創新）、或是藉由組織重整（例如：轉換）。

10.2 不符合性及改正行動(Nonconformity and corrective action)
10.2.1 When a nonconformity occurs, including those arising from complaints, the organization shall:
a) react to the nonconformity and as applicable:
    1) take action to control and correct it;
    2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
    1) reviewing the nonconformity;
    2) determining the causes of the nonconformity;
    3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the quality management system, if necessary.  
Corrective actions shall be appropriate to the effects of the nonconformities encountered.  
NOTE 1.  In some instances, it can be impossible to eliminate the cause of a nonconformity.  
NOTE 2.  Corrective action can reduce the likelihood of recurrence to an acceptable level.

10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.

10.3 Continual improvement
The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.  
The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.  
Where applicable, the organization shall select and ultilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement.  


2013年 CD 版
10.1 Nonconformity and corrective action
When a nonconformity occurs, the organization shall:
(同 Annex SL 10.1)
10.2 Improvement
The organization shall improve the quality management system, processes and goods and services, as appropriate, through responding to:
a) results of analysis of data;
b) changes in the context of the organization;
c) changes in identified risk (see 6.1); and
d) new opportunities.  
The organization shall evaluate, prioritise and determine the improvement to be implemented.


2012 年 WD版
10.1 Nonconformity and corrective action
(同 Annex SL 10.1)

10.2 Improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.
The organization shall define a structured approach for continual improvement of quality management system process and/or product through the use of the outcomes of performance evaluation (see 9).  
The organization shall maintain control over its processes in all areas of its quality management system during continual improvement implementation.  Plans shall be established for change implementation to ensure consideration of the impact in all relevant areas.  
NOTE.  Continual improvement may include processes /approaches such as innovation, lean, six sigma, etc.  

hlperng

2014 年 ISO 9001 的 DIS 版第 5 章「領導」(Leadership) 分為 3 節：5.1「領導與承諾」(leadership and commitment)、5.2「品質政策」(quality policy)、5.3「組織角色、職責與職權」(organizational roles, responsibilities and authorities)
這一章的主角為高層管理(高階管理或最高管理階層)(top management)。

5. 領導 (Leadership)
5.1 領導與承諾 (Leadership and commitment)
5.1.1 Leadership and commitment for the quality management system
Top management shall demonstrate leadership and commitment with respect to the quality management system by: a) taking accountability of the effectivenss of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with strategic direction and the context of the organization;
c) ensuring that the quality policy is communicated, understood and applied within the organization;
d) ensuring the integration of the quality management system requirements into the organization's business processes;
e) promoting awareness of the process approach;
f) ensuring that the resources needed for the quality management system are available;
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
h) ensuring that the quality management system achieves its intended results (outcome(s));
i) engaging, directing and supporting persons to  contribute to the effectiveness of the quality management systems;
j) promoting continual improvement;
k) supporting other relevant management roles to demonstrate their leadership as it applied to their area of responsibility.  
NOTE.  Reference to "business" in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization's existence; whether the organization is public, private, for profit or not for profit.  


5.1.2 顧客聚焦 (Customer focus)
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
d) the focus on enhancing customer satisfaction is maintained.  

5.2 品質政策 (Quality policy)
5.2.1 Top management shall establish, review and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.  
5.2.2 The quality policy shall:
a) be available as documented information;
b) be communicated, understood and applied within the organization;
c) be available to relevant interested parties, as appropriate.

5.3 組織角色、職責與職權 (Organizational roles, responsibilities and authorities)
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.  
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.