Internal audits based on ISO 13485
– for medtech organisations

2-day course

For most companies, continually improving the organisation is a matter of survival. Internal auditing is a powerful tool for studying 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 of 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 in a way that will really benefit the development of your organisation.

The theoretic 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. All exercises and examples are related to ISO 13485.

Topics

  • 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

Target group
This course is intended as an introduction for professionals who are involved in carrying out internal audits according to ISO 13485 or who are responsible for audits within an organisation.

Educational goals
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.

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

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Course Leader/s
Emma Jansson, Senior Quality and Regulatory Consultant

Dates and location

Lund
To be planned

Stockholm
To be planned

Online course
22 – 23 October

NOTE
The course is organized in collaboration with Intertek

Prices
2-day course: SEK 10 800:-
Group registration*

All prices excl. local VAT.

*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Customized training courses and seminars

We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.

Registration

The course is organised in collaboration with Intertek.

Information and registration for this course go here.

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