Internal auditor of the quality management system in the field of medical devices according to the requirements of ISO 13485:2016 and ISO 19011:2018 standards

Course objectives

• prepare internal auditors to perform internal audits in organizations,
• acquaint course participants in detail with the ISO 13485 and ISO 19011 standards requirements,
• familiarize the technique of internal audits performance in organizations,
• point out the key problems that internal auditors face in practice and provide possible solutions

Course content

Day 1:

• Introduction to the quality management systems
• Requirements of ISO 13485 standard
• Comparison with the ISO 9001 standard
• Risk analysis, sterile production, traceability
• Omission of ISO 9001 requirements according to legal requirements

Day 2:

• Requirements of EN ISO 19011 and audit guidance
• Requirements for the internal auditor and internal audits
• Psychological aspects of an audit and effective auditor communication
• Audit preparation, simulated audit, audit report
• The most common mistakes of organizations in performing internal audits
   

Designed for

• Internal Auditor
• Quality Manager

Additional information

* UTC +1 time zone (DE, BE, DK, NL, NO, SE, AT, ES, FR, IT, SI, SK, CZ, PL, HU, ...)