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  • In-house

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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

Training with LR

With LR, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organisation. With many learning styles to choose from, our training courses can help you develop and reach your next level. Find more courses here.

Course Length

  • 5 days for the traditional face to face classroom course
  • For the virtual courses 40 hours delivered in 7 sessions
  • For 7 session virtual classroom proposition, we have completely redesigned the technical content, visuals and delivery methodology of the course to better fit the virtual delivery and address the delegate engagement using technology
  • Delegates attending LR’s virtual classroom 7 session course, will take an online end of module exam at the end of each day, rather than physically sitting a traditional written examination.

CQI & IRCA certified

This Lloyd's Register training course satisfies the formal training requirements stipulated by the CQI & IRCA.

CQI and IRCA certified training is mapped to a unique competency framework based on the latest skills needed by employers. As an Approved Training Partner, LR has been thoroughly assessed to ensure the highest standards.


For more information on Lloyd’s Register’s Approved Training Partner status, please visit the CQI & IRCA website.

Book now View dates & locations

Prices from

Course Type

  • Classroom
  • In-house

Course length


If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.

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