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Quality Management (QMS) 14 items

Quality Manual & Documented Information Structure Checklist

A checklist to design and review a QMS documentation architecture (policy, manual, procedures, work instructions, records) and ensure documented information meets ISO 9001:2015 Clause 7.5 requirements.

ISO 9001:2015

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Documentation Hierarchy

  • Is a clear documentation hierarchy defined (policy, manual/QMS overview, procedures, work instructions, forms/records)? *
  • Does the QMS overview describe scope, process interactions (sequence and interaction of processes), and applicable exclusions? *
  • Are process owners and process performance indicators identified for each core process? *
  • Is the documented information proportionate to organizational size, activities, and process complexity? *

Creating & Updating (Clause 7.5.2)

  • Does each document have appropriate identification and description (title, date, author, reference number)? *
  • Is an appropriate format and media defined and consistent across the QMS? *
  • Is documented information reviewed and approved for suitability and adequacy before release? *

Control of Documented Information (Clause 7.5.3)

  • Is documented information available and suitable for use where and when needed? *
  • Is documented information adequately protected (e.g., from loss of confidentiality, improper use, loss of integrity)? *
  • Are distribution, access, retrieval, storage, version control, and change control addressed? *
  • Is documented information of external origin identified and controlled? *

Retention & Obsolescence

  • Are retention and disposition rules defined for records (documented information retained as evidence)? *
  • Are obsolete documents removed from points of use or clearly marked if retained for legal/knowledge purposes? *
  • List any legacy 'six mandatory procedures' still maintained and confirm they remain fit for purpose

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