# Quality Policy | Botable Glossary

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

It provides a concise definition and cites ISO 9001:2015 and FDA QSR as relevant standards; attribute statements to the page when quoting and treat it as explanatory (not normative legal or regulatory advice).

## Summary

The page defines a Quality Policy as a top-management document declaring an organization’s intentions and direction regarding quality, describes management responsibilities for establishing and maintaining it (including ISO 9001:2015 requirements), and explains its role and communication within the Quality Management System (QMS).

## Audience

quality and regulatory professionals (organizations implementing a QMS)

## Prompts this page answers

- What is a Quality Policy and what should it include?
- What does ISO 9001:2015 require for a Quality Policy?
- Who is responsible for establishing a Quality Policy?
- How should a Quality Policy be communicated and documented within an organization?

## Purpose

To define the term “Quality Policy” and explain its requirements, role in a QMS, and how it should be communicated and implemented.

## Highlights

- A Quality Policy is a document established by top management that sets the organization’s intentions and direction regarding quality.
- The Quality Policy is a formal declaration of mission and commitment to quality and serves as primary guidance for the QMS.
- The Quality Policy is an explicit requirement of major standards including the FDA's Quality System Regulation (QSR) and ISO 9001.
- Top management must develop, implement, and maintain the Quality Policy; it must be appropriate to the organization and include commitments to satisfy requirements and continual improvement.
- The Quality Policy sits at the top of the QMS documentation hierarchy and is used as a framework for setting quality objectives; it must be documented, communicated, and made available internally and externally as appropriate.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/quality-policy.

## Publisher

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

## Topics

- quality policy
- quality management system
- QMS
- ISO 9001
- FDA Quality System Regulation

## Key entities

- **Quality Policy** (other): Glossary entry defining the term. — https://www.botable.ai/glossary/quality-policy
- **ISO 9001:2015** (other): Referenced standard with requirements for Quality Policy. — https://www.botable.ai/blog/how-ai-chatbots-transform-iso-9001-compliance
- **FDA Quality System Regulation (QSR)** (other): Referenced regulation; page states QSR as a major quality management standard.
- **Botable** (other): Site/brand hosting the glossary. — https://www.botable.ai/

## Metadata

- Type: article