ISO 13485 INTERNAL/LEAD AUDITOR COURSE

Service Description

Participants gain a thorough understanding of: - The structure, intent, and requirements of ISO 13485:2016 - The role and responsibilities of a Lead Auditor - Audit planning, execution, communication, and evidence collection - Risk-based thinking and process-based auditing techniques - Handling nonconformities, root cause analysis, and corrective actions - Managing audit teams and resolving audit challenges professionally - Preparing audit reports that meet ISO 19011 guidance Through case studies, role-plays, and hands-on audit simulations, participants develop the competency and confidence required to lead internal and supplier audits. Upon completion, trainees are equipped with the skills needed to ensure QMS compliance and continuous improvement within medical device organizations. Internal Auditor (3 days) + the 4th day for Lead Auditor training. Date: APRIL 20th - 23rd, 2026