Become a Certified Lead Auditor. Audit with Confidence. Lead with Impact.

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This comprehensive online certification course empowers you to become a globally recognized ISO 13485:2016 Lead Auditor, equipped with the skills to conduct, manage, and lead audits of Medical Devices Quality Management Systems (MDQMS) in compliance with ISO 13485:2016.

What You'll Gain:

• Lead MDQMS audits with authority – confidently plan, conduct, and report internal and external audits based on ISO 13485:2016.

• Work with Certification Bodies / Independent Consultant – Qualify to perform third-party certification audits or work as a consultant or full-time auditor in the medical devices sector.

• Interpret ISO 13485 requirements and apply them in real-world audit situations within the medical device industry, including regulatory compliance aspects.

• Conduct audit meetings – manage opening and closing meetings with stakeholders and clients effectively.

• Lead audit teams – understand roles, responsibilities, and team dynamics for efficient audit execution.

• Identify and document nonconformities – based on actual standards, best practices, and regulatory requirements.

• Review, write, and improve audit reports – create professional, actionable audit documentation that adds value.

• Learn risk-based thinking, documented information requirements, and practical audit approaches guided by ISO 19011 and ISO/IEC 17021-1.

• Access real-life audit videos and case-based practical sessions tailored to medical device quality management auditing for a hands-on learning experience.

Upon successful completion of session assessments and the final exam, you will receive an Exemplar Global-certified Lead Auditor Certificate, empowering you to:

• Promote yourself as a qualified Lead Auditor in the global medical device quality management job market.

• Add value to your current role or start a career in medical device quality auditing or consulting.

• Become a trusted partner to organizations aiming to achieve and maintain ISO 13485 certification.

Enroll now to take the next step in your professional journey and lead audits that truly make an impact on medical device safety and quality.

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Course Objectives – Exemplar Global Certified ISO 13485 Lead Auditor

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• Understand the principles and structure of the ISO 13485:2016 Medical Devices Quality Management System (MDQMS), including the Plan-Do-Check-Act (PDCA) cycle.

• Interpret and apply ISO 13485:2016 clauses and sub-clauses, with a deep understanding of the regulatory requirements and the high-level structure.

• Analyze organizational context, including internal and external factors, and the needs and expectations of interested parties in the medical device industry.

• Comprehend the roles of leadership, strategic planning, support processes, operations, and performance evaluation specific to MDQMS.

• Learn how continual improvement is achieved through effective MDQMS implementation and auditing with a focus on patient safety and regulatory compliance.

• Gain hands-on experience in conducting medical device audits, including planning, executing, reporting, and following up on audit results.

• Understand and implement the use of audit checklists, audit interviewing techniques, and proper documentation practices tailored to medical device regulations.

• Learn to conduct effective opening and closing meetings during external audits in the medical device context.

• Master the process of preparing and maintaining internal audit records and documented information as per ISO 13485:2016.

• Understand risk-based thinking, risk assessment, and how to evaluate and address risks within the MDQMS framework to ensure product safety and compliance.