QKC20181012：讀書會_管理系統標準 (MSS) 與高階架構 (HLS)

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品質學會品質知識社群 (QKC) 讀書會
專題：管理系統標準 (MSS) 與高階架構 (HLS)
時間：2018 年 10 月 12 日(星期五) 15:00 - 18:00   
地點：品質學會九樓教室（台北市羅斯福路 2 段 75 號）
引導：彭鴻霖會友

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鑑於標準的目的在累積經驗與知識，透過標準化活動，以系統化、共同協調一致的方法，強化標準制定實務，建立制度化程序以供傳承。2000 年起 ISO 技術管理委員會 (TMB) 規劃分三個階段進行管理系統標準 (management system standards, MSS) 標準化工作，規劃在 2015 年完成各項管理系統事項調和工作。2001 年 ISO 出版 ISO Guide 72 (Guidelines for justification and development of management system standards)，作為擬訂管理系統之依據。2006 年 ISO TMB 檢討品質管理 (ISO 9000)、環境管理 (ISO 14000) 等各種管理系統標準，成立管理系統標準策略諮詢群 (SAG MSS)，要求第 13 技術顧問群 (Technical Advisory Group, TAG) 又稱聯合技術協調群 (Joint Technical Coordination Group, JTCG) 發展各項管理系統之共同願景 (joint vision)，並調準現有的管理系統標準與新訂的管理系統標準，整合管理系統、稽核與符合性評鑑標準，涉及 ISO/CASCO (符合性評鑑) 及 ISO/TC 176 (產品品質管理)、ISO/TC 207 (環境管理) 及 ISO/TC 34 (食品安全管理) 等技術委員會。2008 年 JTCG 完成草案，2009 年 4 月 10 日提出 MSS 建議書：ISO/TMB/TAG13-JTCG/TG3/N34，供各技術委員會審查。2009 年 4 月 23 日以 ISO/IEC JTC1/SC27/N7616 號文件發行 MSS 建議書。2010 年 5 月 17 日 JTCG 提出 MSS 高階結構，以及一致性本文與共用名詞草案 (Draft high level management system structure with draft identical text and common terminology)，以 JTCG/TF1/N28 及 JTCG/TF3/N086，發文分送各標準化機構進行研究並提供意見。
2011 年 ISO TMB 發行 ISO Guide 83 草案 (High level structure and identical text for management system standards and common core management system terms and definitions)，此一指引草案為管理系統標準高階架構的前身。
2012 年 ISO TMB 發行的ISO/IEC 指令 1 附件 SL：「管理系統標準的建議書」，定義管理系統標準的格式必須採用統一的 10 章「高階結構」(high level structure, HLS) ，根據標準內容的約束力，管理系統標準分為 A 與 B 兩類，A 類 MSS 提供要求 (requirements)、B 類 MSS 提供指南 (guidelines)。依照標準的應用領域，分為通用 (generic) 標準與行業特定 (sector-specific) 標準。通用要求標準、行業要求標準、通用指南標準、特定指南標準等國際標準之間的關聯性如下圖所示。

附錄 SL「高階架構」 規定所有的「管理系統標準」國際標準文件總共有 10 章，其高階架構統一為 10 章架構的標準格式：
      0. 簡介 (introduction)

• 範圍 (scope)
• 規範性引用文件 (normative references)
• 名詞與定義 (terms and definitions)
• 組織內涵 (context of organization)
• 領導 (leadership)
• 規劃 (planning)
• 支援 (support)
• 運作 (operation)
• 績效評估 (performance evaluation)
• 改進 (improvement)
  

領域 (discipline) 相關管理系統	行業 (sector) 相關管理系統
品質管理 (quality management) (A-HLS) ISO 9001:2015, Quality management systems - Requirements	通信行業 (Telecommunication) TL 9000:2017-R6.1, Quality management system for the telecommunications industry
財務管理 (finance management) ISO/TR 13569:2005, Financial service - Information security guidelines	航空行業 AS 9100D:2016, Quality management systems - Requirements for aviation, space, and defense organizations
環境管理 (environmental management) (A-HLS) ISO 14001:2015, Environmental management systems - Requirements with guidance for use	醫療器材 (medical devices) (A) ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes
符合性管理 (compliance management) (B-HLS) ISO 19600:2014, Compliance management systems - Guidelines	車輛行業 IATF 16949:2016, Quality management system for organization in the automotive industry
永續事件管理 (sustainable event management) (A-HLS) ISO 20121:2012, Event sustainability management systems - Requirements with guidance for use	選務機關 (electoral bodies) ISO/TS 17582:2014, Quality management systems - Particular requirements for the application of ISO 9001:2008 for electoral organizations at all levels of government
營運持續管理 (business continuity management) (A-HLS) ISO 22301:2012, Societal security - Business continuity management systems - Requirements	地方政府 (local government) ISO 18091:2014, Quality management systems - Guidelines for the application of ISO 9001:2008 in local government
資訊安全管理 (information security management) (A-HLS) ISO 27001:2013, Information technology - Security techniques - Information security management systems - Requirements	資訊系統與服務 (information systems and services) ISO 20001:2013, Information technology - Security techniques -Information security management systems - Requirements
供應鏈管理 (supply chain management) (A) ISO 28001:2007, Security management systems for the supply chain - Best practices for implementing supply chain security, assessments and plans - Requirements and guidance	教育機構 (educational organizations) (HLS) ISO 21001:2018, Educational organizations - Management systems for educational organizations - Requirements with guidance for use
記錄管理 (record management) (A-HLS) ISO 30301:2011, Information and documentation - Management systems for records - Requirements	食品安全 (food safety) (HLS) ISO 22000:2018, Food safety management systems - Requirements for any organization in the food chain
人力資源管理 (human resource management) (A-HLS) ISO/DIS 30401, Knowledge management systems - Requirements	鐵路應用 (Railway application) (HLS) ISO/TS 22163:2017, Railway applications - Quality management system - Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector
風險管理 (risk management) ISO 31000:2018, Risk management - Guidelines	石化與天然氣 (petroleum, petrochemical, and natural gas)  (A-HLS) ISO 29001:2010, Petroleum, petrochemical and natural gas industries - Sector-specific quality management systems - Requirements for product and service supply organizations
反賄賂管理 (anti-bribery management) (A-HLS) ISO 37001:2016, Anti-bribery management systems - Requirements with guidance for use	道路交通安全管理 (Road traffic safety) (A-HLS) ISO 39001:2012, Road traffic safety (RTS) management systems - Requirements with guidance for use
社區永續發展管理 (sustainable development in communities) (A-HLS) ISO 37101:2016, Sustainable development in communities - Management system for sustainable development - Requirements with guidance for use	軟體 (software) (B) ISO 90003:2014, Software engineering - Guidelines for the application of ISO 9001:2008 to computer software
設施管理 (facility management) (A-HLS) ISO 41001:2018, Facility management - Management systems - Requirements with guidance for use	系統工程 (systems engineering) (B) ISO 90005:2008, Systems engineering - Guidelines for the application of ISO 9001 to system life cycle process
共同營運關係管理 (collaborative business relationship management) (A-HLS) ISO 44001:2017, Collaborative business relationship management systems - Framework	資訊技術服務管理 (IT service management) (B) ISO 90006:2013, Information technology - Guidelines for the application of ISO 9001:2008 to IT service management and its integration with ISO/IEC 20000-1:2011
職業健康與安全 (occupational health and safety) (A-HLS) ISO 45001:2018, Occupational health and safety management systems - Requirements with guidance for use
能源管理 (energy management) (A-HLS) ISO 50001:2018, Energy management systems - Requirements with guidance for use
創新管理 (innovation management) (B-HLS) ISO/DIS 50501, Innovation management - Innovation management system - Guidance
資產管理 (asset management) (A-HLS) ISO 55001:2014, Asset management - Management systems - Requirements

相關標準連結：

• ISO 13845:2016, Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 19600:2014, Compliance management systems - Guidelines
• ISO 22000:2018, Food safety management systems - Requirements for any organization in the food chain
• ISO 22163:2017, Railway applications - Quality management systems - Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector
• ISO 22301:2012, Societal security - Business continuity management systems - Requirements
• ISO 39001:2012, Road traffic safety (RTS) management systems - Requirements with guidance for use
• IATF 16949:2016, Quality management system for organization in the automotive industry
• TL 9000, Quality management system for the telecommunications industry
• AS 9100D:2016, Quality management systems - Requirements for aviation, space, and defense organizations
  

參考資料：

• ISO Management System Standards, ISO 網站
• 下載完整的 MSS 清單，excel 格式
• ISO/IEC 指令第 1 部 (2018) - ISO 補充彙總 - ISO 特定程序 - 附錄 SL：管理系統標準的建議書
• 附件 SL、MSS A 類與 MSS B 類標準清單，維基百科
• David Brewer (2013), Understanding the New ISO Management System Requirements
• R. Dan Reid (2014), Standard Outlook - Into the Future - How key management system standards are changing, Quality Progress, ASQ, 2014