Internal audits based on ISO 13485
– for medtech organisations

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
Ladan Amiri, Senior Quality and Regulatory Consultant