ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
Description:
- 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.
Previous skills/knowledge:
- Knowledge of ISO 13485 requirements
- Professional experience, including in medical devices management systems – ISO 13485 (recommended)
- Knowledge of the methods and techniques of assessment.
Authorized Partners:
Teaching requirements: Trainer should to be a qualified ISO 13485 Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:
- Be qualifiable as ISO 13485 internal auditor (additional requirements from qualifying entity may apply)
- Understand the principles of internal audit
- Be able to assume responsibilities in any activity of the internal auditing process
- Understand the functions and competences that any auditor must have to carry out first, second party, and certification audits
- Be able to apply auditing guidelines to ISO 13485 internal audits.
