The course helps you understand the requirements of ISO 13485 and apply them as an auditor. In short and varied sessions, you will acquire the necessary knowledge about audits. You will learn how to implement this knowledge in workshops and role-plays.
During the course, you will learn how to:
We discuss each ISO 13485 requirement in detail and develop practical examples. In varied sessions, we evaluate whether a requirement has been implemented in a conforming or non-conforming manner.
I was particularly impressed by the high level of competence of the trainers – they were very attentive, always encouraging, and positive. Questions were always answered, and discussions were possible at any time. Very varied and entertaining, especially thanks to the different working methods.
Upon passing an exam, you will receive a certificate attesting to your newly acquired knowledge and capabilities at the end of the week. The exam is online and conducted by an independent, accredited examination organization. You will answer 75 multiple-choice questions on complex scenarios within two hours. The exam fee is charged in addition to the seminar price.
The course is suitable for individuals who conduct audits of quality management systems in accordance with ISO 13485 and wish to obtain certification. Typical course participants are (future) quality managers at medical device manufacturers, service providers, and notified body employees.
At the end of the course, an external, accredited organization (APMG) will conduct an online exam (duration: approx. 60 min). Upon passing this exam, you will receive an officially recognized certificate in addition to your certificate of participation, which attests to your newly acquired knowledge and capabilities.
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The course covers the following topics:
After the course, you will be able to:
This course is designed for individuals who plan and conduct audits of quality management systems according to ISO 13485 and wish to obtain a corresponding, recognized certificate.
Typical course participants are (future) quality managers at medical device manufacturers, service providers, and notified body employees.
Participants can easily follow this course even without any special prior knowledge. A general understanding of standards and knowledge of ISO 13485 are helpful.
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 courses, you will receive two e-mails: The first contains the final link to the course 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 course 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.
The course takes place either in person or online over five days (spread over two weeks), daily from 9:00 am to 5:00 pm during the specified period. There will be a one-hour lunch break every day and short breaks as needed. The individual content will be taught in a flexible and situation-specific manner, so a standardized schedule cannot be provided here.
Our online/remote seminars and courses are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the course 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 course, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
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.
Andreas Kalchschmid-Lehmann is an expert in QM and in vitro diagnostic medical devices with more than 17 years of practical experience. He is the author of the book “ISO 13485 – Chance statt Hürde” (ISO 13485 – Opportunity instead of obstacle) and has relevant experience in other quality management systems, including ISO 17025, ISO 15189, MDSAP, and CFR 820. As former quality manager, he knows how to set up and implement a QMS successfully. He worked as a product specialist and lead auditor at a large notified body. Today, as a widely recognized expert, he supports our customers and trains auditors for notified bodies as a lecturer in a certified course at the Johner Institute.
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.
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.
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