Certified ISO 13485 Lead Auditor Course (five days)

Become a lead auditor yourself and meet auditors from notified bodies at
eye level

The course helps you to understand the requirements of ISO 13485 and to apply them as an auditor. In short and varied sessions, you will gain the necessary knowledge about audits. You will learn how to implement them in workshops and role plays.

Next Seminar

Certified ISO 13485 Lead Auditor Course (five days)
Speaker: Andreas Kalchschmid-Lehmann, Claudia Volk
Location: Online Seminar
Language: English
Seats available
Additional information

1. Day 20.08. 9-17 Uhr 2. Day 21.08. 9-17 Uhr 3. Day 27.08. 9-17 Uhr 4. Day 28.08. 9-17 Uhr 5. Day 29.08. 9-17 Uhr

Your Price
3600 €
plus VAT.
4284,00 € (incl. VAT.)

After only five days, you will have mastered the planning, implementation, and follow-up of effective quality management system audits

During the course, you will learn to

  • create audit plans and prepare individual audit sessions,  
  • collect evidence of (non-)compliance using the methods of interviewing, observing, and evaluating documentation,  
  • report these in accordance with the requirements of ISO 19011,  
  • conduct opening and closing meetings, and  
  • follow up on any deviations identified.

A certificate proves your ability to implement audits under ISO 13485 confidently
and professionally

At the end of the week and upon passing an examination, you will receive a certificate attesting to your newly acquired knowledge and capabilities. The examination takes place online and is conducted by an independent, accredited organization. You will have two hours to answer 75 multiple-choice questions on complex scenarios. The exam fee is included in the seminar price.  

Complete the course that notified bodies also use to train their auditors

The course is suitable for people who wish to carry out audits of quality management systems in accordance with ISO 13485 and obtain certification. Typical course participants are (future) quality managers at medical device manufacturers and service providers, as well as employees at notified bodies. 

You can find the exact learning content as well as the schedule of the seminar in the agenda:

Download Agenda (PDF)


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