1. ISO 9000 系列修訂版的主要目的(本文參考ISO/TC 176/SC2/N1269 www.iso.org/tc176/sc02/public)
    1. 發展出簡化的標準以適用於各種大中小型組織,及
    2. 因應組織過程活動目的發展所需之相關的大量與詳細文件系統

      ISO 9001:2015引許組織彈性的選擇建置其品質管理系統QMS文件
      促使組織展示QMS過程控管及實施與持續改善之有效計畫/運作,他強調: "文件化的品質管理系統",非"文件系統"
  2. 文件化資訊之定義與依據
    1. High Level Structure (HLS)及Management System Standards (MSS)文件化資訊可以用來溝通,提供證明該計劃被確實執行或分享
    2. 下列為組織文件化資訊之主要目的(不管其是否為執行QMS:
      1. 溝通
      2. 資訊傳輸與溝通之工具. 其型態與深度因應組織文化背景\活動過程及人員能力之不同而異
    3. 符合之證據,證實計劃確實被執行之必須證明
    4. 知識分享
    5. 宣傳與保存組織經驗,例如:技術規格書可被設計研發新產品來引用

      文件資訊型式包括:
      1. paper 紙本
      2. magnetic 磁卡
      3. electronic or optical computer disc  電子檔或視訊光碟
      4. photograph 相片
      5. master sample 樣品
  3. Guidance on Clause 7.5 of ISO 9001:2015
    1. 高階文件必須涵蓋: QMS (high level transversal documents)
      1. The scope of the quality management system (clause4.3).
      2. Documented information necessary to support the operation of processes (clause4.4).
      3. The quality policy(clause 5).
      4. The quality objectives(clause 6.2).
      5. This documented information is subject to the requirements of clause 7.5.
    2. 低階文件Low level, specific documents). 可以是:
      1. Organization charts
      2. Process maps, process flow charts and/or process descriptions
      3. Procedures
      4. Work and/or test instructions
      5. Specifications
      6. Documents containing internal communications
      7. Production schedules
      8. Approved supplier lists
      9. Test and inspection plans
      10. Quality plans
      11. Quality manuals
      12. Strategic plans
      13. Forms
    3. 提供結果之證據,包括:
      1. Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4).
      2. Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).
      3. Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).
      4. Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2).
      5. Results of the review and new requirements for the products and services (clause 8.2.3).
      6. Records needed to demonstrate that design and development requirements have been met (clause 8.3.2)
      7. Records on design and development inputs (clause 8.3.3).
      8. Records of the activities of design and development controls (clause 8.3.4).
      9. Records of design and development outputs (clause 8.3.5).
      10. Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6).
      11. Records of the evaluation, selection, monitoring of performance and re-evaluation of external providers and any and actions arising from these activities (clause 8.4.1)
      12. Evidence of the unique identification of the outputs when traceability is a requirement (clause 8.5.2).
      13. Records of property of the customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3).
      14. Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken (clause 8.5.6).
      15. Records of the authorized release of products and services for delivery to the customer including acceptance criteria and traceability to the authorizing person(s) (clause 8.6).
      16. Records of nonconformities, the actions taken, concessions obtained and  the identification of the authority deciding the action in respect of the nonconformity (clause 8.7).
      17. Results of the evaluation of the performance and the effectiveness of the QMS (clause 911)
      18. Evidence of the implementation of the audit programme and the audit results (clause 9.2.2).
      19. Evidence of the results of management reviews (clause 9.3.3).
      20. Evidence of the nature of the nonconformities and any subsequent actions taken (clause 10.2.2).;
      21. Results of any corrective action (clause 10.2.2). 
  4. 組織正要投入ISO 9001QMS,須考慮
    1. determining the processes necessary for the effective implementation of the quality management system
    2. determining  the interactions between these processes.
    3. documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process mapping tools. It is emphasized, however, that documented process mapping tools are not a requirement of ISO 9001:2015).
    4. Analysis of the processes should be the driving force for defining the amount of documented information needed for the quality management system, taking into account the requirements of ISO 9001:2015. It should not be the documented information that drives the processes.
  5. 組織由ISO 9001: 2008 投入ISO 9001: 2015 QMS,了解其中之不同：
    1. An organization with an existing QMS should not need to rewrite all of its documented information in order to meet the requirements of ISO 9001:2015. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach.  
    2. An organization may be able to carry out some simplification and/or consolidation of existing documented information  in order to simplify its QMS.
  6. 如何證實符合ISO 9001:2015
    1. Organizations may be able to demonstrate conformity without the need for extensive documented information
    2. To claim conformity with ISO 9001:2015, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.3 of ISO 9000:2015 defines “objective evidence” as “data supporting the existence or verity of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
    3. Objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001:2015. In some cases, (for example, in clause 8.1 (e) Operational planning and control, it is up to the organization to determine what documented information is necessary in order to provide this objective evidence. 
    4. Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2015. In these situations, both internal and external audits may use the text of ISO 9001:2015 for conformity assessment purposes. 當組織對某一特定活動無文件資訊提供時,且其非標準所規定者,這樣的活動在根據ISO 9001:2015相關條款下執行時,是可被接受的,此時可以使用內外部稽核證實其符合評估