We’ve detected that you are using an outdated browser. This will prevent you from accessing certain features. Update browser


ISO 13485 Auditor/Lead Auditor - IRCA & CQI Certified.

This course is certified by CQI and IRCA and meets the requirements of the CQI and IRCA QMS Lead Auditor course criteria IRCA/2245 13/2

Find out more about our training courses


This five-day training Lead Auditor course outlines the necessary skills needed to audit Quality Management Systems against ISO 13485 requirements.

Successful completion adds to your credibility with a widely accepted qualification, satisfies the formal training requirements stipulated by the CQI & IRCA and enables you to conduct external audits against ISO 13485.

Who should attend?

Professionals who want to audit Quality Management Systems against ISO 13485 requirements and want to satisfy the formal training requirements for IRCA certification.

What will you learn?

  • The purpose of a QMS based on ISO 13485 and the ISO 9000 principles
  • Essential definitions and terminology
  • To analyse ISO 13485 clauses and identify conformance with requirements
  • The role and responsibilities of an auditor and lead auditor
  • To plan and conduct an interview with top management and evaluate an organisation’s quality policy and objectives
  • To prepare an on-site audit plan that establishes effective audit trails 
  • To audit processes for conformance and effectiveness
  • To prepare thoroughly for audit and produce process based checklists
  • To gather and evaluate objective evidence
  • To identify conformance and non-conformance with requirements
  • To report findings accurately against requirements of ISO 13485
  • To write and grade non-conformity reports and evaluate proposals for corrective action
  • To relate your audit findings to the policy and objectives of the organisation and present your overall evaluation to top management
  • The requirements to become a registered auditor/lead auditor with IRCA

What do you need to prepare?

  • Knowledge and understanding of ISO 13485 and experience of auditing
  • Ideally to have attended our ISO 13485 Internal Auditor course
  • Basic understanding of how organisations work and the role of top management
  • Complete approximately 3 hours of pre-course work prior to attending the course

Your future development

Course length

Five days


Available delivery methods


Delivered by one of our expert trainers who facilitates participation and discussion.

Find out more about our training courses

Hit enter or the arrow to search Hit enter to search

Search icon

Are you looking for?