External auditor of the quality management system in the field of medical devices according to the requirements of the ISO 13485:2016 standard

Course objectives

The objective of the training is to prepare external / lead auditors in detail to perform external audits in organizations, to introduce the technique of external audits in organizations and to point out the problems encountered by external auditors in various types of organizations. The auditor will be qualified to perform second and third-party audits in accordance with the ISO 13485:2016 standard and related regulatory requirements.

Participants in this training are expected to have mastered the application of auditing quality management systems and quality management systems in the field of medical devices, at least at the level of leading internal auditors.

Course content

• Clarification of the requirements of ISO 13485:2016, ISO 19011:2018, ISO / IEC 17021-3:2017 standards
• 8 principles of quality management
• Comparison of ISO 13485 with ISO 9001
• Omission of ISO 9001 requirements according to legal requirements
• Risk analysis, sterile production, traceability
• Difference between independent audits by the other party and the third party
• Requirements of ISO 19011 and audit guidance
• The task and role of the external auditor
• Qualification requirements and competence of the external auditor
• Psychological aspects of the audit and effective communication of the auditor
• Effective management of the initial external audit visit
• Review, monitor and develop the audit program
• Interpretation of the procedure and principles of external audit
• How to evaluate audit findings, categorization of discrepancies
• Audit preparation, simulated audit, audit report
• Certificate award process, regular supervisory audits, accreditation schemes
• Solving specific model situations and practical examples
• Presentation of protocols from external audits and case studies
• Execution of the final professional test

Designed for

• Internal Auditor

Additional information

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