How to Manage Document and Record Control Across ISO Standards
Document and record control is a foundational requirement of any management system—whether you're working with ISO 9001 (quality), ISO 14001 (environment), ISO 27001 (information security), ISO 45001 (safety), or others. These controls ensure that accurate information is available where and when it's needed—and that obsolete or incorrect documents don’t compromise performance or compliance.
This guide offers practical, standard-agnostic guidance on setting up and managing document and record control in a way that supports clarity, compliance, and continuous improvement.
Why Document and Record Control Matters
Accuracy and consistency: Standardized documents ensure everyone is using the most current procedures and forms.
Traceability: Controlled records provide evidence of conformity to requirements and the effectiveness of your management system.
Audit-readiness: Demonstrates you’ve established and maintained required controls.
Risk reduction: Prevents errors due to outdated or misused information.
Key Definitions
Document: Controlled information that supports operations (e.g., policies, procedures, forms, work instructions).
Record: Evidence that an activity or outcome occurred (e.g., completed checklists, inspection reports, training logs).
Step-by-Step: Document and Record Control
1. Define Roles and Responsibilities
Clearly defining roles is the backbone of effective document and record control. Without clear accountability, documents may become outdated, inconsistently applied, or misfiled—leading to audit findings and operational risk.
Actionable Guidance:
Assign process owners to oversee documents relevant to their functions. They are responsible for ensuring accuracy, relevance, and timely updates.
Appoint a document control coordinator or quality manager to maintain oversight of the entire system, ensure consistency, and coordinate change control.
Clearly define responsibilities for:
Document authorship and subject matter input
Technical and compliance reviews
Formal approvals (including management sign-off where applicable)
Distribution and withdrawal of superseded versions
Thoughtful Considerations:
Include document control responsibilities in job descriptions and onboarding.
Use RACI charts (Responsible, Accountable, Consulted, Informed) to clarify involvement across departments.
Consider backup roles to maintain continuity in case of staff turnover or absence.
Align role definitions with your organization's structure—centralized models may suit small organizations, while distributed models work better in larger or multi-site settings.
2. Establish Document Control Rules
Well-defined rules provide structure and reduce ambiguity in how documents are handled throughout their lifecycle.
Core Controls Should Address:
Unique document identification (e.g., numbering system, title, revision code)
Structured review and approval process before release
Controlled distribution to ensure availability at the point of use
Version control with revision history and change descriptions
Controlled withdrawal and archiving of obsolete documents
Prevention of unintended use through clear labeling (e.g., “Obsolete” watermark)
Actionable Guidance:
Use a document control matrix to track current status, owners, and next review dates.
Require all changes to be justified and logged.
Assign review cycles (e.g., annual, biannual) and send reminders to owners.
Use document headers/footers to display version number, effective date, and approval.
Implement read-only access for finalized documents to prevent unauthorized edits.
3. Control Record Retention and Access
Records are essential proof that activities were completed and that the management system is functioning effectively. Poor record control undermines traceability and audit credibility.
Core Controls Should Address:
Storage format (paper vs. digital) and filing structure
Access permissions based on job function or confidentiality
Backups and disaster recovery
Retention periods aligned with laws, regulations, contracts, and internal needs
Secure and compliant disposal of obsolete records
Actionable Guidance:
Include retention timelines in a Record Retention Schedule.
Use secure access controls in digital systems.
Ensure that record retrieval is quick and traceable—label files with descriptive naming conventions.
Train users to distinguish between documents and records (e.g., a form template vs. a completed form).
Define who can create, modify, archive, or delete records—limit permissions based on function.
Periodically review access rights and retention timelines for relevance and compliance.
4. Use Tools That Match Your Needs
The best tools are those your team will consistently use. Choose solutions that fit your organization's size, maturity, and complexity—whether manual, digital, or hybrid.
Tool Categories:
Manual systems: Binder-based or paper systems for very small operations
Shared digital folders: Google Drive, OneDrive, or Dropbox with structured permissions
Dedicated QMS platforms: Tools like QT9, Greenlight Guru, or MasterControl
LIMS or ERP integrations: For labs or manufacturing environments where documents tie to workflows
Tips:
Avoid overcomplication—choose systems your team will actually use.
Use metadata (e.g., process owner, document type, effective date) to enable searchability and filtering.
Build folder structures that mirror your organizational processes or departments.
Integrate reminders or workflows for reviews and updates where possible.
Pilot new systems with a small team before organization-wide rollout to resolve usability issues early.
5. Train Staff on Document and Record Expectations
A document control system is only as strong as the people using it. Ensure all employees understand how to interact with controlled documents and records.
Training Should Include:
Where to find current documents
How to fill out and file records properly
What to do with obsolete documents or forms
How to suggest document improvements
Examples of common errors (e.g., using outdated forms, saving to wrong folders)
Consequences of document misuse (e.g., audit findings, product errors)
How to escalate concerns or inconsistencies
6. Monitor and Improve
Effective document and record control systems require continual oversight. Changes in staff, tools, or business needs can introduce drift or inconsistency if not regularly assessed.
Review Periodically:
Is the control procedure still working?
Are documents being reviewed on time?
Are records retrievable, complete, and accurate?
Audit Suggestions:
Spot check version use and record completeness during routine activities.
Use internal audits to sample documents for version control, completeness, and alignment with SOPs.
Review document revision histories for excessive changes or lack of control.
Collect user feedback on document usability and update formats based on real-world use.
Establish KPIs (e.g., on-time review rates, audit findings related to document use) to monitor performance.
Best Practices
Centralize control but decentralize ownership. A single oversight role (e.g., Quality Manager) ensures consistency, while process owners manage content.
Establish a review calendar. Set review intervals for each document and automate reminders if possible.
Limit formats. Standardize templates and file formats to reduce confusion.
Use revision logs. Clearly note what changed and why for every version update.
Label everything. Ensure all documents display title, version, owner, and effective date.
Separate drafts and live documents. Maintain clear boundaries between in-development documents and approved versions.
Audit regularly. Include document and record control in both internal and supplier audits.
Common Pitfalls to Avoid
Unclear ownership. Without clear roles, documents can become stale or inconsistent.
Inconsistent formats. Multiple versions of templates or uncontrolled edits erode trust in documentation.
Overcomplication. Too many rules, folders, or systems discourage adoption.
Infrequent reviews. Stale documents can cause audit issues and operational errors.
Mixing up documents and records. Using uncontrolled forms as records (or vice versa) weakens traceability.
Failure to train. Staff unaware of document rules are likely to bypass controls.
Poor digital organization. Inconsistent naming or filing structures slow down retrieval and increase errors.
Conclusion
Document and record control is more than just a compliance exercise—it’s a mechanism for clarity, consistency, and risk reduction. By implementing a structured and user-friendly approach, you ensure your management system is not only certifiable—but functional.
Written by Wintersmith Advisory – helping organizations design management systems that work on paper and in practice.
