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

• Basic understanding of quality management system principles and ISO standards.

• Familiarity with medical device industry processes and regulatory requirements.

• Experience in auditing, quality assurance, or manufacturing (preferred but not mandatory).

• Proficiency in English (reading, writing, and communication).

• Laptop or desktop with stable internet connection (for online training).

• Webcam and microphone for interactive sessions and exams.

• Ability to open PDF, Word, and Excel files.

• 100% attendance required for all training sessions.

• Completion of all assignments, workshops, and group activities.

• Successful completion of Exemplar Global TPECS examination for:

  • MD – ISO 13485:2016 Medical Devices

  • QM – Quality Management Systems

  • AU – Management Systems Auditing

  • TL – Leading Management Systems Audit Teams

The ISO 13485:2016 (Medical Devices — Quality Management Systems) Lead Auditor Training offered by SQC Training Academy, approved by Exemplar Global – TPECS, is designed to equip participants with the knowledge and skills required to perform effective audits of medical device quality management systems.

This comprehensive training provides a deep understanding of ISO 13485:2016 requirements, auditing principles, and best practices for assessing compliance in the medical device industry. Participants will learn how to plan, conduct, report, and follow up on audits in accordance with ISO 19011 and ISO/IEC 17021 standards.

Through interactive sessions, practical workshops, and real-life case studies, this course helps professionals develop competence in managing audit teams and ensuring regulatory compliance. Successful candidates will be qualified to lead internal and external audits and support organizations in achieving and maintaining ISO 13485 certification.

• Understand the requirements of ISO 13485:2016 for medical devices.

• Gain knowledge of quality management system principles and regulatory compliance.

• Develop competence in planning, conducting, and reporting audits.

• Learn to perform risk-based auditing and identify non-conformities effectively.

• Acquire skills to lead and manage audit teams.

• Apply ISO 19011 auditing guidelines in real-world scenarios.

• Enhance ability to support organizations in achieving and maintaining ISO 13485 certification.

• Build confidence in conducting internal and external audits for medical device companies.

• Prepare for the Exemplar Global TPECS Lead Auditor Examination