Public Training: Internal Auditor ISO 13485:2016

October 03, 2019

Date: 3rd and 4th of October 2019

Location: The Netherlands, Amsterdam area

Language: English

Costs: Regular € 1350


In this two-day course, Internal auditor ISO 13485:2016, you will learn the insights of the audit process, your role as internal auditor and how to use the Standard as the basis for a Quality Management System audit.

During the course, key-concepts and requirements of internal auditing are discussed, but moreover you will also have ample time to train your auditing skills. The course will gain you an awareness and experience with all the aspects of being an internal auditor.

Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.

Why should you attend this course?

This training covers the key concepts of internal auditing like the process approach, the risk-based approach and the assessment of key requirements of ISO 13485:2016. The training is a combination of gaining knowledge on the audit process and methods and obtaining skills to translate this into pragmatic approaches auditing a Quality Management System for organizations in the Medical Device Industry. You will actually prepare, perform and report an internal audit during this course!

Learning objectives:

  •          Understanding the purpose of internal auditing according ISO 13485:2016 and how to challenge ISO 13485 requirements in your audits
  •         Understand the typical audit activities and your role and responsibilities as internal auditor
  •         Get acquainted with different audit methods and he “process approach” and the “risk-based approach” in internal auditing
  •         Learn how to use the concepts of audit objective, scope and criteria
  •         Obtain the basic skills to prepare, execute and report an internal audit
  •         Learn how to write clear and unambiguous observations to initiate proper corrective actions

Program overview:

Key concepts of ISO 13485:2016

Introduction typical audit activities

Audit methods and approaches

Initiating the audit

Preparing the audit

Conducting the audit

Documenting the audit results

Who should attend this course?

If you are (to be) involved as Internal auditors and anyone involved in the implementation and maintenance of a Quality Management System in the Medical Device Industry.


Peter Reijntjes
Post date: May 03, 2019
How can we help you? Contact us