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QHSE Glossary

Document Control

The management of documents throughout their lifecycle — creation, review, approval, distribution, and retirement.

Document Control

Document Control (Managing Documented Information) is a critical concept in quality, health, safety, and environmental management.

What Is Document Control?

Document control is the systematic management of documents throughout their lifecycle: creation, review, approval, distribution, use, revision, and disposal. ISO 9001:2015 Clause 7.5 requires organisations to control documented information — ensuring it is available where needed, adequately protected, and subject to version control. A document control system must prevent use of obsolete documents, maintain revision history, control access and permissions, and provide evidence of approval. In regulated industries, document control requirements are more stringent: FDA 21 CFR Part 11 governs electronic records, and EU GMP Annex 11 covers computerised systems.

Document Control Requirements Under UK Law

ISO 9001:2015 Clause 7.5 mandates documented information control. FDA 21 CFR Part 11 requires system validation, audit trails, electronic signatures, and access controls for electronic records. EU GMP Annex 11 applies to pharmaceutical manufacturers. BS EN 15713 covers secure destruction. GDPR requires documented data protection policies. In aerospace, AS9100 Clause 7.5 adds configuration management requirements. Failure to control documents has resulted in FDA Warning Letters (14% cite document control failures), MHRA enforcement, and loss of ISO certification.

Key Components of Document Control

  • Quality manual
  • Standard operating procedures (SOPs)
  • Work instructions
  • Forms and templates
  • Policies
  • External documents (standards
  • regulations)
  • Records
  • Technical drawings

Document Control in Practice

A pharmaceutical manufacturer (150 employees, 2 sites) manages 2,800 controlled documents in Q-Hub. When a production SOP requires updating, the author creates a new revision — triggering a 3-stage approval workflow (Department Head → Quality Manager → Regulatory Affairs). Average approval cycle: 4.2 days (down from 23 days with paper). On approval, Q-Hub automatically distributes the new version to 45 affected staff, requires electronic acknowledgement (read and understood), and archives the previous version. Their FDA inspector reviews the complete audit trail in Q-Hub — every change, every approval, every signature timestamped.

How to Manage Document Control with Q-Hub

Q-Hub provides comprehensive tools for Document Control management. The Document Control module handles the core requirements. Combined with document control, audit scheduling, and training management, Q-Hub ensures your Document Control processes are audit-ready at all times.

Related Terms

Want to see how Q-Hub handles Document Control in practice? Book a demo or see pricing.

Related QHSE Terms

  • AS9100 — The aerospace quality management standard, based on ISO 9001 with additional requirements for aviati
  • Audit — A systematic, independent examination of processes, products, or systems to verify compliance with d
  • Bow-Tie Analysis — A visual risk assessment method that maps the causes of an event, the event itself, its consequences
  • CAPA — Corrective and Preventive Action — a systematic approach to investigating root causes of non-conform
  • COSHH — Control of Substances Hazardous to Health — UK regulations requiring employers to control exposure t
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