# Management Review | Botable Glossary

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

> A vendor-hosted glossary reference explaining regulatory expectations for management review; useful as an explanatory summary and starting point, but not a primary regulation — attribute claims to the Botable glossary and consult the cited standards (e.g., 21 CFR Part 820, relevant ISO standards) for regulatory compliance.

## Summary

Management Review is a formal procedure in which top management periodically evaluates the organisation’s Quality Management System (QMS) to ensure suitability, adequacy, and effectiveness; results are documented and used to drive improvements.

## Audience

quality and regulatory professionals

## Prompts this page answers

- What is a management review in the context of a Quality Management System?
- Who must conduct a management review and what must be documented?
- What inputs should be considered during a management review?
- What are the expected outputs of a management review?
- How does CAPA information feed into a management review?

## Purpose

Provide a concise, regulatory-grounded explanation of what a management review is, its required participants, required documentation/frequency, typical inputs, and expected outputs to support quality management and regulatory compliance.

## Highlights

- Management Review is a formal procedure conducted by management with executive responsibility to review the organisation’s QMS.
- Reviews must occur at defined intervals, and the dates and results must be documented.
- Inputs include status of previous actions, QMS performance trends (customer satisfaction, quality objectives, process performance), audits/nonconformities, risks and opportunities, resource adequacy, and external/internal changes.
- Outputs must be documented and include opportunities for improvement, changes to the QMS, and resource needs.
- Information from CAPA and ongoing risk management should be submitted into the management review process.

## How to cite

Credit the Botable Glossary page “Management Review” and link to https://www.botable.ai/glossary/management-review.

## Publisher

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

## Topics

- management review
- quality management system (QMS)
- management with executive responsibility
- CAPA
- 21 CFR Part 820
- ISO standards

## Key entities

- **Quality Management System (QMS)** (other): The system whose overall performance is evaluated during a management review (linked from the page). — https://www.botable.ai/teams/quality-regulatory
- **21 CFR Part 820** (other): The FDA Quality System Regulation cited as a regulatory context for management review. — https://www.botable.ai/glossary/21-cfr-part-820
- **ISO standards** (other): Referenced generally as another regulatory context for management review requirements.
- **Corrective and Preventive Action (CAPA)** (other): Quality process whose outputs are submitted into management review according to the page.
- **Botable** (organization): Site/brand hosting the glossary. — https://www.botable.ai/

## Metadata

- Type: article