ISO 13485:2016 (Medical devices — Quality management systems) Internal Auditor Training

• Basic understanding of Quality Management Systems (QMS)

• Familiarity with medical devices industry processes (preferred but not mandatory)

• Knowledge of ISO 13485:2016 standard is an advantage

• Experience in quality, regulatory, production, or compliance roles is beneficial

• Ability to understand and communicate in English

• Interest in learning internal audit principles and techniques

The ISO 13485:2016 Internal Auditor Training is designed to provide participants with comprehensive knowledge of the Medical Devices Quality Management System and the skills required to conduct effective internal audits in accordance with ISO 13485:2016.

This course covers the requirements, principles, and structure of ISO 13485, along with risk-based thinking, documentation control, regulatory alignment, and audit planning. Participants will learn practical internal auditing techniques, including audit preparation, execution, reporting, and follow-up of corrective actions.

Through expert-led sessions, real-world examples, and interactive discussions, learners will gain the confidence to plan, conduct, and report internal audits that support compliance, product safety, and continual improvement within medical device organizations.

Upon successful completion, participants will receive an Exemplar Global–accredited certificate from SQC Certification Services Pvt. Ltd., enhancing their professional credibility and career opportunities in the medical devices industry.

After successful completion of this course, participants will be able to:

• Understand the requirements and structure of ISO 13485:2016

• Interpret ISO 13485 requirements in the context of medical device organizations

• Apply risk-based thinking and regulatory requirements effectively

• Plan, conduct, and manage internal audits in line with ISO 13485 guidelines

• Identify nonconformities, root causes, and improvement opportunities

• Prepare clear and effective audit reports and follow up on corrective actions

• Support organizations in achieving and maintaining ISO 13485 compliance

• Enhance professional competence as a qualified ISO 13485 Internal Auditor