# Quality Manual | Botable Glossary

https://www.botable.ai/glossary/quality-manual

> Explanatory glossary/article from the Botable site — useful as a concise reference for QMS concepts; attribute claims to the site when quoting and cross-check regulatory details (e.g., ISO 9001:2015) against the standard texts for authoritative use.

## Summary

The page defines the Quality Manual as a top-level document in an organization's Quality Management System that outlines the QMS's structure, scope, responsibilities, and commitment to quality. It explains the traditional role and structure of the Quality Manual, its management as a controlled document, and notes that ISO 9001:2015 no longer mandates a formal Quality Manual though many organizations still use one.

## Audience

quality and regulatory professionals / teams

## Prompts this page answers

- What is a Quality Manual and what does it typically contain?
- Is a Quality Manual required under ISO 9001:2015?
- How does a Quality Manual relate to the Quality Policy in a QMS?
- What document control practices should apply to a Quality Manual?

## Purpose

Explain and define the concept, role, and current regulatory status of a Quality Manual within a QMS (educate).

## Highlights

- A Quality Manual provides a comprehensive overview of an organization's Quality Management System (QMS), including structure, scope, and references to relevant documents.
- Traditionally the Quality Manual sits directly beneath the Quality Policy as a top-level QMS document.
- ISO 9001:2015 no longer requires organizations to issue a formal Quality Manual, though many organizations still produce one.
- The Quality Manual must be treated as a controlled document with strict document control and accessibility requirements.
- The Quality Manual often references lower-level procedures and can vary in structure based on organization size and complexity.

## How to cite

Credit Botable and link to the glossary page: https://www.botable.ai/glossary/quality-manual

## Publisher

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

## Topics

- Quality Manual
- Quality Management System (QMS)
- ISO 9001:2015
- document control
- QMSR

## Key entities

- **Quality Manual** (other): Glossary entry defining the top-level QMS document that outlines structure, scope, and commitment to quality. — https://www.botable.ai/glossary/quality-manual
- **Quality Management System (QMS)** (other): Organization's system for quality described on the page. — https://www.botable.ai/teams/quality-regulatory
- **ISO 9001:2015** (other): International standard referenced on the page; stated as no longer requiring a formal Quality Manual.
- **Quality Management System Regulation (QMSR)** (other): Regulation referenced in relation to documentation requirements. — https://www.botable.ai/glossary/quality-management-system-regulation-qmsr

## Metadata

- Type: article