ISO13485:2016 – from an auditing perspective

How do you audit risk-based approaches, change control, and compliance with national regulations?

This one-day online course gives you a clear understanding of the ISO 13485:2016 requirements from an auditing perspective. You’ll learn how to assess your quality management system for both compliance and efficiency, using tools and guidance from the ISO 13485 Handbook. Whether you’re performing internal audits or preparing for supplier evaluations, this course will help you navigate key areas like process performance, quality plans, and management reviews.

What You’ll Learn:

· How to audit ISO 13485:2016 requirements in practice

· The link between ISO 13485 and national regulations

· What to look for in quality plans, change control, and risk-based processes

· How to evaluate Management Reviews for relevance and impact

· Tools to assess, audit, and improve your QMS

Who Should Attend:

Professionals implementing, maintaining, or auditing a medical device QMS

Those needing to demonstrate compliance with ISO 13485:2016

Prerequisites:

Basic knowledge of quality systems and 6–12 months’ experience in the regulated industry

Instructor:

Åse Ek – more than 20 years of experience in the Medical Device and Pharmaceutical industries