Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.

You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. Acquire the skills to initiate, plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.

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ISO 13485:2016 learning path and combination discount

The ISO 13485:2016 Lead Auditor learning path is modular. You can follow the training in all combinations. We recommend the following order:

Stappenplan Engels

Besides this introduction course, are the following training courses also part of the ISO 13485 learning path:

1. ISO 13485 Introduction

2. ISO 13485 Implementation 

3. ISO 13485 Internal Auditor 

4. ISO 13485 Lead Auditor

Attending several training courses of a learning path is associated with special discounts. 

 Training course
Combination training 1 + 2 
Combination training 1 + 3
Combination training 1 + 4
Combination training 1 + 2 + 3
Combination training 1 + 2 + 3 + 4

In-house training course
If more employees need to understand, implement, audit, your management system, training can be delivered at your location. Based on your learning needs we could provide a customized in-house training course for your team. For more information about the learning path or in-house training courses, please contact our training team via +31 20 346 0780 or send an email to