What Makes a Document “Controlled”?
A controlled document is one that is formally managed within a document control system to ensure that:
- Only the latest approved version is in use (avoids outdated instructions).
- Changes are tracked (revision history is recorded).
- Distribution is managed (who has access, who received copies).
- Authorization is clear (prepared/reviewed/approved by the right people).
- Obsolete versions are removed (to prevent accidental use).
In short: controlled documents are official, version-controlled, and traceable.
Examples of Controlled Documents
- Quality Manuals (QMS / ISO 9001)
- Standard Operating Procedures (SOPs)
- Work Instructions
- Policies
- Forms & Templates (if they affect quality/environment/safety processes)
- Technical Specifications & Drawings, Recipes, etc
How They Differ from “Uncontrolled Documents”
| Controlled Documents | Uncontrolled Documents |
|---|---|
| Issued through a document control process | May be created/used without approval |
| Have a unique identifier (Doc No.) | Often no formal reference number |
| Version & revision history tracked | May not show updates or approvals |
| Approved before use (sign-off by management) | No formal review/approval required |
| Marked with control notes (e.g., “Uncontrolled when printed”) | No disclaimer |
| Obsolete copies are withdrawn/archived | Old versions may still circulate |
| Used in core business processes affecting compliance | Used for general reference or informal communication |
Why It Matters (Especially for ISO)
- Prevents mistakes (e.g., using an outdated procedure).
- Ensures compliance with ISO requirements (9001, 14001, 27001, etc.).
- Provides evidence during audits that your business manages information consistently.
- Builds trust that your processes are repeatable and reliable.
Simple Rule of Thumb:
If a document directly affects product/service quality, compliance, safety, or legal requirements, it should be a controlled document.
If it’s just informational, temporary, or internal notes, it can remain uncontrolled.
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