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Catalog · Procedures

Document Control Procedure Template

The SOP every other SOP depends on — creation, review, approval, distribution, revision and obsolescence of QMS documents, with each section mapped to the §4.2.4 requirement it satisfies.

DOCX template8 procedure stepsMapped to ISO 13485:2016 §4.2.4
  • Adopt the procedure first — document control is the SOP your auditor reads before any other
  • Cover the full lifecycle: creation through obsolescence, including external documents and uncontrolled copies
  • Show §4.2.4 coverage sub-requirement by sub-requirement instead of arguing it from prose
What's inside

Built like the working documents we write about

  • Ready-to-adopt document shell

    Document-control header, approvals block and revision history — the procedure practices what it preaches.

  • Document creation

    Identification, legibility and format rules from the first draft, so records are controlled from birth.

  • Review, approval and release

    Adequacy review before issue, and distribution that puts the current revision at the point of use.

  • Revision and periodic review

    Change identification, re-approval, and a review clock so documents cannot silently go stale.

  • Obsolete and external documents

    Withdrawal rules that prevent unintended use, plus identification and controlled distribution of external documents.

  • Uncontrolled copies

    The escape valve, defined — when a copy may exist and how it is marked.

The source map

Why each section exists

Bundle shops sell you a zip and a wish. Every section of this document states the clause it was written to satisfy — the same map is printed inside the document, where your auditor can read it.

Document sectionSatisfies
6.1 Document creationISO 13485 §4.2.4(e) · documents remain legible and readily identifiable
6.2 Review and approvalISO 13485 §4.2.4(a) · review and approval for adequacy prior to issue
6.3 Release and distributionISO 13485 §4.2.4(c)–(d) · current revision status identified; relevant versions available at points of use
6.4 RevisionISO 13485 §4.2.4(b)–(c) · review, update and re-approval, with changes identified
6.5 Periodic reviewISO 13485 §4.2.4(b) · documents reviewed and updated as necessary
6.6 Obsolete documentsISO 13485 §4.2.4(h) · preventing unintended use, with identification of obsolete documents retained
6.7 External documentsISO 13485 §4.2.4(f) · external documents identified and their distribution controlled
6.8 Uncontrolled copiesISO 13485 §4.2.4(d), (h) · copies controlled so only current versions are in use
Whole documentFDA QMSR (21 CFR 820, eff. 2026-02-02) · incorporates ISO 13485:2016 by reference
The details

Exactly what you get

No surprises at download time — the format, the scope, and the license, stated up front.

Format
Microsoft Word (.docx) — no macros, works in Google Docs
Length
9 sections · 8 procedure steps · approvals and revision-history tables included
Mapped to
ISO 13485:2016 §4.2.4 sub-requirement by sub-requirement, plus FDA QMSR (21 CFR 820)
Works with
RT-SOP-007 CAPA Procedure and the RT-LOG-003 Controlled Document Register (coming to the shelf)
Delivery
Instant download after checkout, with a re-download link on your receipt
Updates
Revised when the source moves; buyers get the new revision by email, free
License
One purchase covers your team at one company site

Check our work

Document control is the procedure that decides whether every other document in your QMS can be trusted. Read the craft behind it: what a document control SOP actually controls and how a template goes stale.

Take the sop template to work today.

One purchase, yours immediately at launch — and revised for free when the source moves.

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