Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course ISO 13485:2016

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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Who should attend?

  • Anyone with the need to audit an organization’s ISO 13485:2016 QMS like:
  • Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management Representatives
  • Quality Directors
  • Consultants 


You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.

It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits.

Delegates will be able to:

  • Identify the purpose and benefits of an ISO 13485:2016 QMS
  • Explain the role of an auditor to plan, conduct, report and follow up an Audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
  • Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)

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 - € 770,-

2. ISO 13485 Implementation - € 1.485,-

3. ISO 13485 Internal Auditor - € 1.485,-

4. ISO 13485 Lead Auditor - € 3.490,-

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

 Training course Investment Discount
Combination training 1 + 2  € 2.155 € 100
Combination training 1 + 3 € 2.155 € 100
Combination training 1 + 4 € 4.085 € 175
Combination training 1 + 2 + 3 € 3.515 € 225
Combination training 1 + 2 + 3 + 4 € 6.830 € 400

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

Practical information

  • The Lead Auditor is an intensive training course and will be completed by an official BSI exam
  • It's a 5-day course (first days at least till 18:00)
  • The training and materials will be provided in English
  • Lunch and drinks are included for the classroom training
  • There is a requirement for delegates to undertake some evening preparation or assignments on days 1-4 (Approximately 2-3 hours)

For further information regarding reduced rates at the hotel where the training is being conducted please contact or call +31-(0)20-346 0780.