ICTQual ISO 13485 Medical Devices QMS Internal Auditor

This ICTQual AB course is a 5-day internal auditor training programme delivered through Approved Training Centres, with mandatory assessment and study units focused on ISO 13485, auditing, compliance, risk management, and continual improvement.

The ICTQual ISO 13485 Medical Devices Quality Management System Internal Auditor Course is designed to provide learners with the knowledge and skills needed to audit medical device quality management systems according to ISO 13485 requirements.

• Develop knowledge of ISO 13485 and medical device quality management systems

• Understand how ISO 13485 supports regulatory compliance and product safety

• Build practical internal audit skills for medical device organizations

• Learn how to identify nonconformities and opportunities for improvement

• Understand the role of risk management in medical device QMS auditing

• Support continual improvement, stakeholder confidence, and audit readiness

Learners will develop knowledge and practical understanding of ISO 13485 requirements, internal audit principles, audit techniques, risk management, performance evaluation, compliance, communication, and continual improvement.

• Explain the purpose, scope, and benefits of ISO 13485 for medical device quality management

• Interpret ISO 13485 clauses and apply requirements to medical device operations

• Define the role and purpose of internal audits in medical device quality management

• Apply audit techniques including interviews, observations, document reviews, and evidence gathering

• Identify risks related to design, manufacturing, distribution, and post-market surveillance

• Evaluate compliance, report audit findings, and support corrective action and continual improvement

This course is intended for learners and professionals involved in medical device manufacturing, quality assurance, regulatory affairs, auditing, compliance, supplier management, or quality management systems.