Maps to
FDA QMSR (Part 820): §820.40
ISO 13485: ISO 13485 §4.2.4
Requirement text
Documents required by the quality management system shall be controlled. A documented procedure shall define controls for approval, review, update, identification of changes, availability, legibility, and prevention of unintended use of obsolete documents. FDA-Plus: Documents must be available at all points of use. Changes must be approved by the same function that performed the original approval unless specifically designated otherwise.
Atomic constraints
- •A document control procedure must be documented.
- •Documents must be reviewed and approved before issue.
- •Current revision status must be identifiable.
- •Relevant versions must be available at points of use.
- •Changes must be identified, reviewed, and approved.
- •Obsolete documents must be prevented from unintended use.
- •External documents must be identified and controlled.
Evidence signals
- •
FILE_EXISTS
(Document.*Control|Doc.*Register|Master.*List|SOP.*Control)
- •
CONTENT_MATCH
Does this document describe procedures for document approval, revision control, change tracking, distribution, and obsolete document management?
Audit defense
Document control for our QMS is governed by [your document ID]. All documents undergo formal review and approval before release, with revision history maintained in our master document register. Obsolete documents are archived with clear marking to prevent unintended use.