# Quality Management System (QMS) | Botable Glossary

https://www.botable.ai/glossary/quality-management-system-qms

> Company-published glossary / informational article — useful as an introductory reference and overview. Treat statements as explanatory content from Botable rather than independent regulatory guidance; verify regulatory requirements (e.g., FDA specifics or certification processes) against primary sources when making compliance decisions.

## Summary

This glossary entry defines a Quality Management System (QMS) as a formalized framework of processes, procedures, responsibilities, and resources to ensure consistent quality. It describes key standards (ISO 9001, ISO 13485, and the FDA QMSR), foundational principles (process approach, risk-based thinking, PDCA), core QMS sub-systems (management responsibility, document control, design controls, CAPA, purchasing controls, quality audits), typical QMS documentation, and common implementation challenges.

## Audience

Quality/regulatory professionals and practitioners (including medical device manufacturers and others working with QMS), as well as general readers seeking a QMS definition.

## Prompts this page answers

- What is a Quality Management System (QMS)?
- What are the differences between ISO 9001 and ISO 13485?
- What are the foundational principles of a QMS?
- What subsystems should a QMS include (e.g., CAPA, document control)?
- What common challenges do organizations face when implementing a QMS?

## Purpose

To explain and define what a Quality Management System is, describe relevant standards and principles, outline major QMS sub-systems and documentation, and surface challenges organizations face when implementing a QMS.

## Highlights

- QMS is a structured framework of processes, procedures, responsibilities, and resources to ensure consistent quality.
- ISO 9001 is the generic international standard for QMS; ISO 13485:2016 is the medical-device-specific QMS standard.
- The U.S. FDA amended 21 CFR Part 820 in the 2024 Final Rule to the Quality Management System Regulation (QMSR), incorporating ISO 13485:2016 and parts of ISO 9000:2015 by reference.
- Foundational QMS concepts include the process approach, risk-based thinking, and the Plan–Do–Check–Act (PDCA) cycle.
- Key QMS sub-systems include management responsibility, document control, design controls (for devices), CAPA, purchasing controls, and internal quality audits.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/quality-management-system-qms.

## Publisher



## Topics

- Quality Management System
- QMS
- ISO 9001
- ISO 13485
- QMSR
- CAPA
- document control

## Key entities

- **ISO 9001** (organization): The most widely recognized international standard that defines requirements for an effective QMS (as described on the page).
- **ISO 13485:2016** (organization): The international QMS standard specific to medical devices (as described on the page).
- **U.S. Food and Drug Administration (FDA)** (organization): Referenced for Quality System Regulation (QSR) / Quality Management System Regulation (QMSR) and 21 CFR Part 820 (as described on the page).

## Metadata

- Type: article