Seminar "Internal Auditor Medical Devices according to ISO 13485"

Cheerful People Listening to a Seminar
Acquire the necessary competencies to support the success of your company significantly
Cheerful People Listening to a Seminar
Acquire the necessary competencies to support the success of your company significantly

This seminar provides you with the necessary competencies to conduct effective audits in your company as an internal auditor, regardless of the type of quality management system you have. 

It helps you identify and eliminate vulnera­bilities in the system and optimally prepares your company for audits by external bodies.

Online Seminar

11. - 12.
November 2025
seats available
Speaker
Claudia Volk

Language
Deutsch
Further information about the seminar as well as the schedule can be found in the information sheet:
1360,00 € plus VAT.
1618,00 € (incl. VAT.)

We show you why internal audits give you certainty for future audits by external bodies

You will first learn why internal audits deliver real added value to your com­pany. To do this, we explain the requirements of EN ISO 19011:2018 and the idea and theoretical pro­cess of an internal audit. We then go through the standard's contents in detail. This audit guideline applies to any type of management system.

100% of participants recommend this seminar!

I liked the role-playing exercises best (especially the actors, who gave a great performance!), as they prepare you to deal with the unex­pec­ted (important tips and tricks).

There were lots of practical tips and experience reports from the instructors and participants to help us understand what we had learned in a more practical way.

The instructor is responsive to the participants, really tries hard to create a pleasant learning atmosphere, has a lot of experience  and you can tell.

seminar participants

Use internal audits to identify and improve ineffective processes in your company

Through practical exercises based on ISO 13485, you will learn how to:

  • plan and prepare internal audits in a standard-compliant and goal-oriented manner.
  • conduct audits and audit discussions with confidence.
  • evaluate audit results correctly and document them in accordance with standards.
  • identify meaningful improvement measures.
  • initiate appropriate corrections and corrective actions and track their implementation.

Learn from our experts, who also regularly train emplo­yees from notified bodies

Our experienced experts will provide you with the necessary knowledge and capabilities in a practical and easy-to-understand manner. During the seminar, they will be at your side with valuable tips and show you how to deal with potential conflict situations and avoid typical difficulties.

Certificate

During the seminar, we will carry out various exercises. These exercises are designed to reinforce what you have learned and also serve as a test of effectiveness. In addition to your certificate of attendance, you will receive a certificate confirming your newly acquired knowledge and capabilities.

Got questions about our seminars?
Phone Icon

Phone

+49 7531 94500 20

Contact Form Icon

Contact Form

Further Information

Learning Content

The seminar covers the following topics: 

  • Basics of internal audits, regulations, types of audits, audit principles 
  • Qualifications and requirements for auditors according to ISO 19011:2018 
  • Risk-based approach according to ISO 19011:2018 
  • Creation of an audit programme and development of an audit checklist 
  • Conducting an audit with interview techniques and transaction analysis 
  • Evaluation of audit results and preparation of an audit report 
  • Deviations and potential for improvement 
  • Determination and tracking of corrective actions
Learning Objectives

After the seminar, you will be able to: 

  • plan, conduct, and follow up on risk-based audits. 
  • evaluate conformity and non-conformity (using ISO 13485 as an example). 
  • deal professionally with challenging discussion situations. 
  • apply the basic requirements of ISO 19011:2018.
Target Group

This seminar is designed for individuals who want to conduct audits themselves (supplier audits, internal audits), e.g., quality managers or process owners from specialist departments.

Requirements for Participation

Participants can easily follow this seminar even without any special prior knowledge. A general understanding of standards and knowledge of ISO 13485 is helpful. 

To participate optimally in the seminar, you will need the ISO 19011 and ISO 13485 standards (the German versions in electronic form). Please get in touch with us if we can assist you with this or provide you with tips.

What happens after registration?

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.

How is the seminar conducted?

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.

What happens if questions or problems arise?

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.

Get to know your trainers

Trainer Claudia Volk

After completing her studies, Claudia Volk gained several years of experience as a quality and regulatory affairs manager in a regulated environment, initially in food production and later as a management representative and PRRC for manufacturers of in vitro diagnostic medical devices. In this role, she established, developed, and audited QM systems and implemented digital QM tools. At the Johner Institute, she supports our customers in setting up and further developing their QM systems and training their employees. 

Trainer Dirk Bethauesser

Dirk Bethäußer has worked in quality management and approval at various medical device manufacturers for over 20 years. He has established, maintained, and continuously developed QM systems. He is also an experienced auditor and a member of the standards committee. He supports our customers in setting up, introducing, and maintaining QM systems. He also provides support with EN ISO 13485 certification and audited QM systems before joining the Johner Institute. 

Inconvenient timing? Here, you will find further dates for this seminar:

There is currently no further seminars.

This seminar can also be booked as an in-house seminar

We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.

Please feel free to contact us​​​​​​​.

X

Privacy settings

We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.