ISO 13485 Lead Auditor Course Overview

The ISO 13485 Lead Auditor course is designed for individuals seeking to master the audit of Medical Devices Quality Management Systems (MDQMS) using the ISO 13485 standard. Through this comprehensive 13485 lead auditor training, learners will understand the course objectives, structure, and the relevant standards and regulatory frameworks. They will learn about the certification process and the fundamental principles of MDQMS.

Participants will gain expertise in Audit principles, preparation, initiating, and conducting both Stage 1 and stage 2 audits. The course delves into On-site audit activities, communication during the audit, and the Creation of audit findings and reports. It also covers the closing of the audit, Evaluating action plans, Managing an internal audit program, and the Competence and evaluation of auditors.

Upon completion of the modules, learners will undertake a Certification Exam to validate their knowledge and skills in auditing MDQMS. This 13485 lead auditor course equips learners with the proficiency to perform and lead MDQMS audits effectively, ensuring compliance with ISO 13485 standards.