hlperng 發表於 2018-10-10 22:19:04

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

本帖最後由 hlperng 於 2018-10-22 09:31 編輯

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


hlperng 發表於 2018-10-10 22:20:36

本帖最後由 hlperng 於 2018-10-12 20:18 編輯

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。
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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






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