---
title: What your quality management system needs for ISO and FDA regulation
canonical: "https://www.qualio.com/resources/iso-and-fda-requirements-for-a-qms"
updatedDate: "2026-10-26T16:24:52.000Z"
description: Download What your quality management system needs for ISO and FDA regulation from Qualio. Expert resource for life sciences quality management and regulatory compliance.
---

## What your quality management system needs for ISO and FDA regulation

## What you'll learn

### Learn about the 12 pillars of quality management from experts with over 30 years of combined experience

### Understand what is needed in an ISO- and FDA-compliant QMS for medtech, biotech, pharma and other life science companies

### Get actionable takeaways and steps to become a healthy, compliant, quality-driven life science organization

### ISO & FDA compliance

Get to grips with your regulatory requirements and learn what you need to do to meet ISO and FDA demands

### 12 pillars of quality

From CAPAs to documents, unpick the core ingredients of the modern QMS and how each contributes to robust compliance

### Quality centricity

Learn how to make quality front and center of your operation