ISO 13485 Lead Auditor
Elevate your auditing capabilities with the ISO 13485 Lead Auditor Training, designed to equip you with the expertise to conduct Medical Devices Quality Management System (MDQMS) audits.
Why Choose ISO 13485 Lead Auditor Training?
Discover the value of becoming a PECB Certified ISO 13485 Lead Auditor. Gain knowledge and skills to plan, carry out internal and external audits, and manage audit programs in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.
Who Should Attend?
Ideal for auditors, managers, and technical experts aiming to lead MDQMS certification audits or enhance their audit process management skills.
Learning Objectives:
- Understand MDQMS operations based on ISO 13485.
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks.
- Learn to plan, lead, and follow-up on a management system audit in accordance with ISO 19011.
- Acquire auditor competencies for planning, leading, drafting reports, and following up on an audit in compliance with ISO 19011.
Educational Approach:
This training combines theory and best practices used in MDQMS audits. Lecture sessions include examples based on case studies, practical exercises with role-playing and discussions, and practice tests similar to the Certification Exam.
Prerequisites:
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles are recommended.
