CAPA & nonconformance templates
Two forms structured around ISO 13485:2016 clauses 8.3 and 8.5. Fill them in on screen, including a 5-Whys root cause analysis, then print or download an editable Word file.
Example templates only. Adapt them to your own procedures, numbering and approval rules before use. Your entries stay in your browser.
CAPA & nonconformance templates
The Word download is free. We only ask for your work email.
Structured around ISO 13485:2016 clauses 8.3 (control of nonconforming product) and 8.5.2 / 8.5.3 (corrective and preventive action).
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CAPA is one of the most frequently cited areas in inspections and audits. Our remote internal audit tests your CAPA process end to end and tells you exactly what to fix.
FAQ
Does every nonconformance need a CAPA?
No. One-off, low-risk nonconformances can be closed with a correction. CAPA is for recurring, systemic or higher-risk issues. Define the criteria in your procedure and record the decision on the NCR.
What makes a good effectiveness check?
Criteria defined before the action is implemented, an objective method (for example, trend data over an agreed period) and a recorded result. “No recurrence” without a defined period and data source is a common audit finding.
Is 5 Whys enough for root cause analysis?
For simple problems often yes. For complex or high-risk issues, combine it with methods such as Ishikawa (fishbone) diagrams or fault tree analysis.