ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
- To follow the instructions of the lead auditor and support him;
- To collect and analyze enough evidences (e.g. through interview, observation and sampling of documentation) to determine the audit findings and define the audit conclusions;
- To document the audit findings;
- To collaborate in drafting the audit report;
- To interchange information with the rest of the members of the audit team and with the auditee personnel.
- Knowledge of ISO 13485 requirements;
- Professional experience, including in medical devices management systems – ISO 13485 (recommended);
- Knowledge of the methods and techniques of assessment.