# ISO 13485 | Botable Glossary

https://www.botable.ai/glossary/iso-13485

> A vendor-hosted glossary/explanatory article: useful as an introductory, summary-level reference for ISO 13485 and related regulatory topics; attribute claims to the Botable glossary when quoting, and cross-check regulatory or normative details against the original standards and regulatory texts for compliance decisions.

## Summary

The page is a glossary entry that explains ISO 13485 as the international standard specifying Quality Management System (QMS) requirements for medical devices, highlights key requirements (CAPA, design control, documentation, risk integration), and summarizes how ISO 13485 relates to ISO 9001, the FDA QMSR (21 CFR Part 820), and EU regulations (MDR/IVDR).

## Audience

medical device professionals and quality/regulatory teams

## Prompts this page answers

- What does ISO 13485 require for a medical device quality management system?
- How does ISO 13485 relate to ISO 9001?
- How does the FDA's QMSR (21 CFR Part 820) incorporate ISO 13485:2016?
- What CAPA requirements are specified in ISO 13485?
- How does ISO 13485 compliance interact with EU MDR and IVDR requirements?

## Purpose

To explain and summarize the ISO 13485 standard and its relationships with related standards and regulations for readers seeking a concise glossary-level reference.

## Highlights

- ISO 13485 is the international standard that defines QMS requirements specifically for medical devices and is considered the medical industry's equivalent of ISO 9001.
- ISO 13485:2016 is a stand-alone standard and compliance with it does not necessarily mean compliance with ISO 9001 (and vice versa).
- The FDA's 2024 QMSR Final Rule incorporates by reference ISO 13485:2016; FDA definitions in 21 CFR 820.3(b) may supersede some ISO 13485 definitions.
- ISO 13485 mandates a CAPA system (covered under Section 8.5, with corrective action in 8.5.2 and preventive action in 8.5.3) and requires risk to be considered throughout the QMS (integration with ISO 14971).
- ISO 13485 aligns closely with EU MDR/IVDR requirements, and manufacturers must demonstrate their QMS meets specific MDR/IVDR provisions such as risk management and clinical evaluation.

## How to cite

Credit Botable (Botable Glossary — "ISO 13485") and link to https://www.botable.ai/glossary/iso-13485.

## Publisher



## Topics

- ISO 13485
- medical device QMS
- CAPA
- ISO 9001
- FDA QMSR 21 CFR Part 820
- EU MDR
- ISO 14971
- post-market surveillance

## Key entities

- **ISO 13485** (other): International standard defining QMS requirements for medical devices (page references ISO 13485:2016).
- **ISO 9001** (other): Related ISO quality standard; discussed in the page's comparison to ISO 13485. — https://www.botable.ai/glossary/iso-9001
- **21 CFR Part 820 (FDA QMSR)** (other): U.S. FDA Quality Management System Regulation referenced in the page. — https://www.botable.ai/glossary/21-cfr-part-820
- **EU MDR (Regulation 2017/745)** (other): European medical device regulation; the page states ISO 13485 largely corresponds to its QMS requirements.
- **EU IVDR (Regulation 2017/746)** (other): European in vitro diagnostic regulation; mentioned regarding QMS and CAPA requirements.
- **ISO 14971** (other): Risk management standard referenced as needing integration into ISO 13485 design controls.
- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai/

## Metadata

- Type: article