ISO 13485 CAPA Template: Procedure and Register

By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 26 October 2026.

Short answer: an ISO 13485 CAPA template needs a procedure, a register, a way to decide whether a problem warrants action, a root cause method and a check that the action worked. The ISO 13485 CAPA & Nonconformance Kit ($79) provides all of these in 11 editable Word and Excel files. ISO 13485 handles corrective action in clause 8.5.2 and preventive action in clause 8.5.3, and FDA's QMSR incorporates both.

See the CAPA & Nonconformance Kit ($79)

What is included in the CAPA kit?

File	What it does
Nonconformance, Concession and CAPA SOP	Sets who can raise a nonconformance, who decides on concessions, and CAPA timescales by risk.
Nonconformance and Incident Register	Logs every nonconformance so trends are visible.
CAPA Initiation Checklist	Decides whether an event needs a CAPA or a simple correction.
Root Cause Analysis Toolkit	5 whys and fishbone worksheets, with a place to record the evidence for the cause.
CAPA Register	Tracks each CAPA from opening to closure.
CAPA Effectiveness Follow-Up Register	Schedules and records the data check after a set period.
CAPA training module	Slides, trainer guide, workbook and assessment for CAPA owners.

The kit is also part of the ISO 13485 Starter Kit ($249) and the Complete QMS Kit ($449). A free CAPA Initiation Checklist lets you try the approach first.

What does a good CAPA record look like?

This is the field structure a CAPA record should hold, whichever template you use:

Source (complaint, audit finding, nonconforming product, trend) and date raised.
Problem statement: what failed, where, how many items, which product.
Containment or correction already taken.
Root cause, with the evidence that supports it.
Corrective or preventive action, owner and due date.
Effectiveness check: the measure, the period, the result.
Closure approval and links to any change control or risk file update.

For a complete filled-in record, read the worked example: a CAPA from complaint to closure.

What does ISO 13485 require for corrective and preventive action?

ISO 13485:2016 has one clause for corrective action (8.5.2) and another for preventive action (8.5.3). FDA noted this when it finalised its Quality Management System Regulation (QMSR) and kept the two separate rather than combining them. In its words, the degree of action should be "appropriate to the magnitude of the problem and commensurate with the risks encountered". Nonconforming product is handled under clause 8.3, and complaint investigations under 8.2.2.

How does the FDA QMSR affect CAPA?

The QMSR took effect on 2 February 2026. It incorporates ISO 13485:2016 by reference in 21 CFR 820.10(a) and removed the former CAPA section (820.100) along with the other detailed Subparts C to O, which are now reserved. FDA states that the substance of the former requirements for passing quality information to management is covered by ISO 13485 clauses 8.2.2, 8.5.2 and 8.3.1. For a mapping of clauses to FDA and EU MDR requirements, see the table on the Complete QMS Kit page. Under the EU MDR, Article 10(9)(l) lists managing corrective and preventive actions and verifying their effectiveness as an element of the manufacturer's quality management system.

Worked next step: close your oldest open CAPA

Download the free checklist and test your three oldest open actions: is there a stated root cause with evidence?
Add an effectiveness measure and date to each one that lacks it.
Log them in a register, so that overdue items surface at management review.

If you have audit findings to close before a re-audit, see CAPA system repair or the consulting page (CAPA and findings response sprint from $2,500).

Frequently asked questions

Is a CAPA needed for every nonconformance?

No. Many nonconformances need only a correction or a concession. The kit's checklist records why a CAPA was or was not opened, so the decision is traceable.

How long should a CAPA stay open?

ISO 13485 sets no fixed number of days. Define timescales by risk in your own procedure; the kit's SOP prompts you to do this.

How do I show a CAPA was effective?

Define a measurable outcome before closing, check it after a set period using data, and record the result. The effectiveness register in the kit is built for this.

Are the files editable?

Yes. They are Microsoft Office files without macros and are licensed for one organisation, including its sites. The templates do not reproduce ISO standards; you need your own copy of ISO 13485.

Sources

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