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Glossary

Nonconformance

Also written: NCP
Category
Quality Events & Corrective Action
Industry
Manufacturing, Medical Device, Aerospace
Required By
ISO 9001:2015 clause 10.2 · ISO 13485
Related Terms
CAPA · Corrective Action · Audit Findings
A nonconformance (NCP) is a documented failure of a product, process, or quality system element to meet a specified requirement.

What is a nonconformance?

A nonconformance occurs whenever a product, process, or service fails to meet a requirement.

Nonconformance classification

Nonconformances are typically classified as minor, major, or critical.

Frequently Asked Questions

What is the difference between a nonconformance and CAPA?

A nonconformance documents the issue while CAPA investigates and prevents recurrence.

Does ISO 9001 require documentation of nonconformances?

Yes. ISO 9001 requires organizations to document and address nonconformities.

Related quality management terms

CAPA, Audit Findings, Root Cause Analysis
Last reviewed: May 19, 2026