# Quality Management | Botable Glossary

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

> A glossary-style explanatory article from the Botable site intended as introductory guidance on quality management concepts and regulatory context; useful as a vendor-published summary and reference, but not primary regulatory text—attribute claims to Botable and verify regulatory specifics from primary standards or regulators.

## Summary

Defines Quality Management as an organizational framework of processes, functions, and intentions to ensure products and services meet standards, customer requirements, and regulatory criteria; explains the role of a Quality Management System (QMS), cites ISO standards and FDA regulation (QSR → QMSR), and describes core processes such as risk management, CAPA, design controls, document control, and internal audits.

## Audience

Quality, regulatory, and quality-management professionals (including medical device manufacturers and compliance teams)

## Prompts this page answers

- What is quality management and what does a Quality Management System (QMS) include?
- How do ISO 9001 and ISO 13485 relate to a QMS for medical device manufacturers?
- What are the core processes like CAPA, risk management, and document control within a QMS?
- What benefits and common challenges are associated with implementing a QMS?
- What is the FDA’s QMSR and how does it relate to the previous QSR (21 CFR Part 820)?

## Purpose

To explain and define the concept of Quality Management and its components, regulatory foundations, processes, benefits, and challenges.

## Highlights

- Quality Management is the organizational framework to ensure products/services meet standards, customer requirements, and regulatory criteria.
- A Quality Management System (QMS) provides a structured framework of processes, procedures, and responsibilities; core components include Quality Policy, Quality Objectives, and documentation.
- The ISO 9000 family (notably ISO 9001) underpins QMS practice; ISO 13485 is the medical-device-specific QMS standard.
- The FDA’s Quality System Regulation (QSR) is transitioning to the Quality Management System Regulation (QMSR), finalized in 2024, which incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015.
- Key QMS processes include risk management, CAPA, design controls, document control, internal audits, and the PDCA cycle; benefits and implementation challenges are also discussed.

## How to cite

Credit Botable Glossary (Botable) and link to https://www.botable.ai/glossary/quality-management

## Publisher

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

## Topics

- quality management
- Quality Management System (QMS)
- ISO 9001
- ISO 13485
- FDA QSR QMSR
- CAPA
- document control
- PDCA

## Key entities

- **Botable** (organization): Website hosting the glossary entry. — https://www.botable.ai
- **Quality Management System (QMS)** (other): Structured framework of processes, procedures, and responsibilities for implementing quality management (described on the page).
- **ISO 9001** (other): ISO 9001 referenced as the standard against which organizations seek certification. — /blog/how-ai-chatbots-transform-iso-9001-compliance
- **ISO 13485** (other): Medical-device-specific QMS standard referenced on the page.
- **FDA Quality System Regulation (QSR) / Quality Management System Regulation (QMSR)** (other): The page states the FDA’s QSR is transitioning to the QMSR, finalized in 2024, harmonizing prior regulation and incorporating ISO 13485:2016 by reference.
- **CAPA** (other): Corrective and Preventive Action process described on the page.
- **PDCA** (other): Plan-Do-Check-Act cycle cited as a common implementation approach.

## Metadata

- Type: article