ISO 13485 Internal Audit Training Course: This course focuses on the process-based approach to conducting internal audits for medical device companies in compliance with ISO 13485 standards.
Participants will learn about the requirements and best practices for a process-based internal audit program, including risk assessment, audit planning, execution, reporting, and follow-up. The course will provide hands-on training and practical techniques for conducting process-based audits, such as process flow analysis, document review, observation and findings. The course aims to link understanding between an organisation’s management system and the requirements of the standard. Upon completion, participants will be equipped with the skills and knowledge needed to perform effective internal audits that ensure ongoing compliance with ISO 13485 requirements with an emphasis on system effectiveness. This course is designed for quality professionals, auditors, and others involved in the internal audit process.
Target
Benefits of ISO 13485 Internal Auditor Training Course:
- Understanding of ISO 13485 requirements and their connection to a quality management system and its processes
- Development of process-based audit techniques for medical device companies
- Ability to identify and assess risks related to medical device quality management systems
- Improved ability to plan and execute effective internal audits
- Improved ability to report findings of internal audits and apply system improvements
- Improved skills in report writing and communication of audit findings
- Gain confidence in your organisation’s ability to carry out effective internal audits
Content
Participants should have a sound understanding of the ISO 13485 standard as well as basic awareness of medical device development. Course material and a loan copy of the standard will be provided. Through a combination of active participation throughout the course as well as completing an exam, participants will receive a certificate of completion.
Auditors
