Kelmac Group® offers an industry-leading ISO 13485 Lead Auditor Training Course, designed for professionals aiming to become certified lead auditors in the medical device quality management system (QMS) sector. This intensive training equips participants with the expertise to plan, conduct, manage, and lead audits against ISO 13485:2016 requirements, following ISO 19011 and ISO/IEC 17021 auditing principles.
Led by expert instructors, this course emphasizes a hands-on, practical learning approach, ensuring real-world audit application. Key topics include audit planning, risk-based thinking, regulatory compliance, and certification body audits. Participants will develop the confidence to conduct independent third-party audits and support organizational compliance.
Ideal for quality managers, regulatory professionals, and aspiring lead auditors, this internationally recognized training enhances career prospects and ensures compliance with global medical device regulations.