Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• Training
• European Authorized Representation

2-day course in Stockholm, 7-8 November 2019.

Internal audits based on ISO 13485 – for MedTech organisations

This course is intended as an introduction to internal auditing for medtech professionals.

Continually improving an organisation is a matter of survival for most companies. Internal auditing is a powerful tool to study the operations in a structured way, with the intention of developing them. As an internal auditor, having a knowledge of auditing techniques and methodologies is central in order to turn auditing results into improvements to the organisation.

Having a good understanding for the requirements in the current standard is also important. In this course, you will get a basic understanding that will help you succeed in carrying out internal audits that really benefit the development of your organisation.

About this course
The theoretical part of the course focuses on auditing techniques and methodology and provides the tools you need to carry out an audit in a professional manner. The practical part of the course includes audit preparation and deviation identification. Exercises and examples are related to ISO 13485.

From the course programme:
· Techniques and approaches
· Different types of audits
· The psychology of auditing
· Internal audit planning
· Audit programmes and audit plans
· Designing a deviation report
· Designing an audit report
· Deviation follow-ups

The goal of the course
After the course, participants will be able to carry out an internal audit of their organisation in a professional manner that will contribute to the improvement of operations.

The intended audience for this course
This course is aimed mainly at professionals who are involved in carrying out internal audits according to ISO 13485 or responsible for audits in an organisation.

Required prior knowledge
We recommend that participants in this course are familiar with quality management systems for MedTech organisations.

Course Leader
Emma Jansson, Senior Quality and Regulatory Consultant at QAdvis
More about Emma >

7–8 November 2019
Day 1: 09:00-16:30
Day 2: 09:00-15:30

Location and Registration
The course is organised in collaboration with Intertek and will be held in Kista, Stockholm. Information and Register for this course here.

Do you want to know more about this course? You are welcome to contact us at utbildning@intertek.com for more information.