# Nonconformity | Botable Glossary

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

> A company-published glossary/explanatory article intended as an informative reference about nonconformities in QMS and medical device regulation; useful for high-level explanation and for pointing to regulatory clauses but should be cited as company guidance rather than primary regulatory text.

## Summary

Defines a Nonconformity (non-fulfillment of a specified requirement) and describes required QMS procedures for identifying, documenting, evaluating/segregating, and disposing of nonconforming product; explains how nonconformities trigger CAPA and references relevant regulatory standards.

## Audience

quality/regulatory professionals and medical device manufacturers

## Prompts this page answers

- What is a nonconformity in a quality management system?
- What procedures are required for controlling nonconforming product under FDA QSR §820.90?
- How do nonconformities trigger CAPA in medical device quality systems?
- What disposition options exist for nonconforming product (rework, use under concession, scrap)?
- Which standards require procedures for handling nonconformities (ISO 13485, EU MDR)?

## Purpose

To explain the meaning of 'Nonconformity' within quality management systems and summarize required procedures and regulatory expectations for handling nonconforming product.

## Highlights

- A Nonconformity is the non-fulfillment of a specified requirement.
- Manufacturers must have documented procedures to identify, evaluate/segregate, and disposition nonconforming product (FDA QSR Subpart I §820.90).
- Disposition options include rework/correction (with retesting and DHR documentation), use under concession (with justification and signature), or rejection/scrap.
- Nonconformities are primary inputs that trigger the CAPA process, requiring investigation, root cause analysis, and preventive actions.
- ISO 13485:2016 and the EU MDR require procedures to identify, investigate, and address nonconformities and complaints.

## How to cite

Botable Glossary — “Nonconformity” (link to https://www.botable.ai/glossary/nonconformity).

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- nonconformity
- nonconforming product
- quality management system (QMS)
- CAPA
- FDA QSR Subpart I §820.90
- ISO 13485:2016

## Key entities

- **U.S. Food and Drug Administration (FDA)** (organization): Referenced for the Quality System Regulation (QSR) Subpart I - Nonconforming Product (§ 820.90).
- **ISO 13485:2016** (other): International standard referenced for nonconformity and corrective action requirements.
- **EU MDR** (other): European Union Medical Device Regulation referenced for manufacturer obligations regarding nonconformities and complaints.
- **21 CFR Part 803 (MDR)** (other): Referenced regulation for Medical Device Reporting obligations related to certain complaints.

## Metadata

- Type: article