Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• European Authorized Representation
Our courses are most often conducted by the experts involved in the development of the standard. The course also focus on practical issues what manufacturers and suppliers need or should do based on our hands-on experience from the medical device industry.
Internal audits based on ISO 13485 – for MedTech organisations
This 2-days 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.
The theoretic part of the course focuses on auditing techniques and methodology, and it provides the tools you need to carry out an audit professionally. The practical part of the course includes audit preparation and deviation identification. Exercises and examples are related to ISO 13485.
- 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 printed course material is in English
Verbal presentation and discussions will be in Swedish
After successfully completed course including a proficiency test participant will receive a certificate
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.
Need of prior Knowledge/Experience
We recommend that participants in this course are familiar with quality management systems for medtech organisations.
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.
QAdvis consultant/s based on the specialist competence required for each course
Please contact us for a discussion, content specification or proposal at firstname.lastname@example.org