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Catalog · Procedures

CAPA Procedure Template

A complete corrective-and-preventive-action SOP for medical device QMS — every section mapped to the ISO 13485:2016 clause and FDA QMSR requirement it satisfies, so you can show an auditor exactly why each paragraph exists.

DOCX template9 sectionsMapped to ISO 13485:2016 & FDA QMSR
  • Start from a CAPA procedure whose structure already answers 8.5.2 and 8.5.3, instead of reverse-engineering the clauses
  • Defend every section in an audit with its stated source — the clause map is in the document, not in your head
  • Keep correction, corrective action and preventive action legally distinct — the definitions section does the separating
What's inside

Built like the working documents we write about

  • Ready-to-adopt document shell

    Document-control header, approvals block and revision history table — route it through your own document control and release.

  • Purpose, scope and references

    Scope covers every CAPA source — nonconforming product, complaints, audits, process monitoring, supplier issues, servicing data.

  • Definitions that hold up in audit

    Correction vs corrective action vs preventive action, separated the way ISO 13485 uses the terms.

  • The seven-step procedure

    Initiation & screening, containment, root-cause investigation, action planning, implementation & verification, effectiveness check, closure & trending — each with guidance on tailoring thresholds.

  • Risk-based prioritization built in

    Screening and investigation depth are proportionate to risk, the posture FDA inspections look for.

  • Records & training sections

    States which records each step generates and where they live, wired for your retention schedule.

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 Initiation and screeningISO 13485 §8.5.2(a), §8.5.3(a) · reviewing nonconformities and detecting potential ones
6.2 Containment / correctionISO 13485 §8.3 · control of nonconforming product before investigation proceeds
6.3 Investigation and root causeISO 13485 §8.5.2(b), §8.5.3(b) · determining causes of actual and potential nonconformities
6.4 Action planningISO 13485 §8.5.2(c)–(d), §8.5.3(c) · evaluating the need for action and planning it
6.5 Implementation and verificationISO 13485 §8.5.2(d)–(e), §8.5.3(d)–(e) · implementing and verifying actions do no harm
6.6 Effectiveness checkISO 13485 §8.5.2(f), §8.5.3(e) · reviewing effectiveness with objective evidence
6.7 Closure and trendingISO 13485 §8.4 · analysis of data; feeds §5.6 management review
Whole documentFDA QMSR (21 CFR 820, eff. 2026-02-02) · incorporates ISO 13485:2016 by reference — one procedure serves both
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 · approvals, revision-history and records tables included
Mapped to
ISO 13485:2016 §8.5.2 & §8.5.3 and FDA QMSR (21 CFR 820), section by section
Works with
RT-FRM-002 CAPA Request & Record form and RT-LOG-001 CAPA Log — sold on this shelf, referenced by number in §3
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

Every section of this SOP states the clause it exists to satisfy — that map is printed above and inside the document itself. The guidance layer (in square brackets, deleted before release) tells you what to tailor and why. Read the craft behind it: what a CAPA tracker has to track and what a complaint record has to decide before it becomes a CAPA.

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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