# Nonconformity Management | Botable Glossary

https://www.botable.ai/glossary/nonconformity-management

> Vendor-hosted glossary article: useful as an explanatory, introductory reference about nonconformity management and its regulatory context. Use it for general definitions and to cite regulatory standards mentioned, but verify specific regulatory or procedural requirements from primary standards or regulatory guidance documents.

## Summary

Defines Nonconformity Management as the structured QMS process to document, evaluate, contain, and remediate product, process, or system deficiencies, and explains how nonconformities trigger CAPA and regulatory documentation requirements.

## Audience

Quality and regulatory professionals (QMS/CAPA practitioners) in regulated industries

## Prompts this page answers

- What is nonconformity management in a QMS and what are its core components?
- How does nonconforming product control relate to CAPA under FDA QSR?
- Which ISO standards require procedures for nonconformities and corrective actions?
- What steps are typically included when handling a nonconforming product?
- How can software (eQMS) support nonconformity and CAPA workflows?

## Purpose

Explain and educate readers about what Nonconformity Management is, its core components (containment and CAPA), relevant regulatory requirements, and how software can support the process.

## Highlights

- Nonconformity Management is the QMS process to define, document, evaluate, and dispose of product, process, or system deficiencies.
- Two main phases: Control of Nonconforming Product (containment) and Corrective Action (CAPA) for prevention.
- FDA QSR (21 CFR Part 820) Subpart I (§820.90) covers nonconforming product; CAPA is required under §820.100.
- ISO 9001:2015 and ISO 13485:2016 mandate procedures and documentation for nonconformities and corrective/preventive actions.
- Nonconformance management software or an eQMS can streamline workflows and tie nonconformity handling into other QMS processes.

## How to cite

Link to the page: https://www.botable.ai/glossary/nonconformity-management

## Publisher



## Topics

- nonconformity management
- CAPA
- control of nonconforming product
- ISO 13485
- FDA QSR 21 CFR Part 820
- eQMS
- root cause analysis

## Key entities

- **Botable** (organization): Site/brand hosting the glossary content. — https://www.botable.ai/
- **ISO 9001:2015** (other): International standard referenced for nonconformity and corrective action requirements.
- **ISO 13485:2016** (other): Medical device QMS standard referenced for corrective and preventive action sections.
- **FDA QSR (21 CFR Part 820)** (other): U.S. regulation referenced, including Subpart I (§820.90) for Nonconforming Product and CAPA (§820.100).
- **EU MDR/IVDR** (other): European regulatory frameworks referenced regarding QMS and postmarket integration with CAPA.
- **CAPA** (other): Corrective and Preventive Action subsystem triggered by nonconformities.
- **eQMS** (other): Enterprise Quality Management System — software referenced as tooling to manage nonconformities.

## Metadata

- Type: article