> iso 134852016 internal auditor training


This 2-day course will help individuals understand the purpose of the quality management system, and the structure and content of ISO 13485, including its relationship with regulatory requirements such as the European Medical Devices Regulations (MDR) and the USA’s FDA Quality System Regulation (QSR). Participants will learn how audits can support the implementation and improvement of a management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes.

Duration: 2 Day, 09.00 – 17.00

Price: £795 +VAT

Who should attend?

  • internal quality management system auditors
  • supplier auditors
  • medical device professionals
  • quality, audit, compliance, and/or regulatory affairs managers
  • auditees preparing for certification audits

Course objectives

Through lectures, discussions and workshops, you will be able to:

  • Learn the principles and practices of the quality management systems (QMS);
  • Understand the interpretation of ISO 13485:2016 Standard, the quality management system and its application to Medical Devices;
  • Develop skills in planning, preparing and performing value-added ISO 13485:2016 audits; preparing audit reports and conducting follow-up verification audits

Course outcomes

By the end of this course ISO 13485 Internal Auditor training course, participants will be able to:

  • explain the purpose, structure and content of ISO 13485:2016 Medical Devices
  • outline the content of EU MDR and the USA FDA requirements for medical devices and their relationship with ISO 13485
  • describe the roles and responsibilities of an auditor
  • plan, conduct, report and follow up an internal audit in accordance with ISO 13485
  • evaluate conformance of processes to ISO 13485 and related internal and regulatory requirements

In house courses

Offering better value for money, they can be designed to closely match your specific requirements.

Style of Delivery and Course Leaders

Our course leaders have extensive experience across a wide range of sectors including manufacturing, service and professional organisations including Local, National and International Government. This wide experience enables them to make the course more interesting by using their relevant examples and case studies during workshop discussions.

Their team of staff has extensive experience of working across cultural boundaries, through their work in Europe, Africa, Middle East, Asia and the Americas.


Delegates successfully completing the course will be awarded a certificate from SAI Global.

Upcoming Courses

21st – 22nd May 2024 | Virtual Delivery – Enquire Now

8th – 9th October 2024 | Virtual Delivery – Enquire Now