ISO 13485 and Quality Management for Medical Devices / Internal Auditing

Introduction

The course will give you an introduction to the ISO 13485 and the knowledge on how to implement a quality management system (QMS) in line with ISO 13485. In addition you will get an insight into the audit process as required by the standard.

The course consists of two parts – ISO 13485 and the related audit process.

The purpose of the course is to provide documented competences in the ISO 13485:2016 standard, and to provide understanding of the audit process.

The course will include class discussions, real life examples and practical exercises as time allows.

Target group

Employees needs an introduction to the planning, implementing and maintenance including auditing of an ISO 13485 quality management system.

This could be employes working in companies that are ISO 13485 certified or are on the way to becoming ISO 13485 certified or are suppliers to companies, which are ISO 13485 certified.

No pre-knowledge and experience with the ISO 13485 standard is required.

Course format

The course consists of two parts.

Part 1: Quality management for Medical Devices and ISO 13485 (2 days)

Part 2: Internal auditing for medical device companies and ISO 19011 (1 day)

Part 1 is offered as an independent course. It lasts 2 days and covers the ISO 13485:2016 standard.

The entire course lasts 3 days and ends with a written multiple choice test.

Course language

The course is in English.

Trainers

Bolette Nordby, Director QA, Medical Devices, Ascendis Pharma A/S
Liselotte Blond Sørensen, Sr. Consultant and Partner, Danish Medical Devices Consulting ApS

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