ISO 13485 Medical Devices Internal Auditor Training

This training provides participants with the knowledge and understanding required to perform internal audits in accordance with the requirements of the ISO 13485:2016 Medical Devices Quality Management System standard.

Participants will gain insight into the fundamental principles of ISO 13485, the structure of quality management systems specific to the medical device industry, and the methodologies used in audit planning, execution, and reporting. The program is designed to support organizations in establishing compliant quality management systems, enhancing existing systems, and managing internal audit processes more effectively.

By the end of the training, participants will have a solid understanding of ISO 13485:2016 requirements and the competencies needed to contribute to effective internal auditing within medical device organizations.

Overview of the principles of the ISO 13485:2016 Medical Devices Quality Management System
Detailed review of all clauses of the ISO 13485:2016 standard supported by objective evidence and practical examples
Introduction to auditing, audit types, and nonconformity classifications
Roles, responsibilities, and competencies of auditors and lead auditors
Audit planning, including the preparation of checklists, audit plans, and related documentation
Conducting audits and reporting audit findings and nonconformities
Evaluation and verification of corrective actions
Practical exercises and case studies
Introduction to certification and accreditation processes
Assessment examination

Professionals working in organizations operating within the medical device industry
Teams responsible for quality management systems and regulatory compliance processes
Individuals currently involved in or planned to participate in internal audit activities
Personnel from production, quality control, and quality assurance departments
Participants seeking to gain knowledge of the ISO 13485 standard and develop competencies as internal auditors