# ISO 13485:2016: QM system for medical devices | INOPREX

> ISO 13485:2016 is the standard for quality management systems in medical devices: structure, requirements, certification and what a manufacturer owes from it.

Quelle: https://inoporex.de/en/wissen/iso-13485/

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## ISO 13485:2016 — the QM system for medical devices

What the standard demands, whom it concerns and what a certified QM system must deliver.

ISO 13485:2016 is the internationally valid standard for quality management systems in the medical device industry. It defines requirements for development, production, storage, distribution and post-market support of medical devices — and is the basis for conformity assessment under EU MDR. Our own QMS under ISO 13485:2016 is currently being established; certification has been initiated.

## Core chapters

- Ch. 4: QM system and documentation
- Ch. 5: Management responsibility, policy, roles
- Ch. 6: Resources, infrastructure, work environment
- Ch. 7: Product realisation — planning, development, purchasing, production, validation
- Ch. 8: Evaluation, analysis, improvement — incl. CAPA

## Differences from ISO 9001

ISO 13485 is more regulation-oriented: documentation duties are tighter, risk management under ISO 14971 is anchored, traceability and document control are stricter.

## Certification and validity

Certification is performed by accredited bodies; certificates run three years with annual surveillance audits.

## Frequently asked questions

**Does ISO 13485 also apply to contract manufacturers?**

Yes, as soon as they manufacture parts of medical devices: suppliers and contract manufacturers fall within scope where their share affects conformity. INOPREX requires this in supplier qualification.

**Is INOPREX certified?**

Not yet. The QMS under ISO 13485:2016 is currently being established; certification has been initiated. We share the current status transparently within the project.

## Applied to your project

We apply these rules directly to your project — from classification to market access. First assessment within two working days.

Stand: 2026-10-22 · Fachlich verantwortlich: INOPREX Scientific Direction