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Introduction

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

Book now View dates & locations

Prices from


Course Type

  • Public
  • In-house

Course length

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