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品質マネジメント(QMS) 14項目

Control of Documented Information Checklist

このチェックリストは英語版です。

Verifies that documented information required by the QMS is created, controlled, and retained in accordance with Clause 7.5.

ISO 9001:2015

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Creation & Updating (Cl. 7.5.2)

  • Do documents carry appropriate identification and description (title, date, author, reference number)? *
  • Is the format and media of documented information appropriate and controlled? *
  • Are documents reviewed and approved for suitability and adequacy prior to use? *

Availability & Protection (Cl. 7.5.3.1)

  • Is documented information available and suitable for use where and when needed? *
  • Is documented information adequately protected from loss of confidentiality, improper use, or loss of integrity? *
  • Are backup and recovery arrangements in place for electronic documented information? *

Control Activities (Cl. 7.5.3.2)

  • Are distribution, access, retrieval, and use controlled? *
  • Are storage and preservation, including legibility, controlled? *
  • Is version and change control (including revision status) applied? *
  • Are retention and disposition defined and followed? *

Obsolete & External Documents

  • Are obsolete documents removed from points of use or clearly identified to prevent unintended use? *
  • Is documented information of external origin identified and controlled? *
  • Sample document reviewed
  • Current revision confirmed at point of use *

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