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  • In-house

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Introduction

This four day course is designed to provide a detailed understanding of the role and responsibilities of an Auditor/Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings.

Who should attend?

  • Auditors or Quality System Managers who need to audit against ISO 13485 requirements
  • Individuals within the medical devices sector who wish to add credibility with a widely accepted qualification.

What will you learn?

  • Purpose of a QMS based on ISO 13485 and the ISO 9000 principles of quality management
  • Essential definitions and terminology
  • To analyse ISO 13485 clauses and suggest examples of evidence that would show conformance with these requirements
  • Roles and responsibilities of an auditor / lead auditor
  • Plan and conduct an interview with top management and evaluate an organisation’s quality policy and objectives
  • Prepare an on-site audit plan that establishes effective audit trails across processes and between members of an audit team
  • To audit processes for conformance and effectiveness, including any specific quality objectives
  • To prepare thoroughly for audit and produce process based checklists
  • To gather objective evidence through observation, interviewing and reviewing documentation
  • To evaluate objective evidence and correctly identify conformance and non-conformance with requirements
  • To report findings accurately against requirements of ISO 13485, 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

What do you need to prepare?

  • Knowledge and understanding of ISO 13485 and experience of auditing
  • Ideally to have attended our ISO 13485 Appreciation and Interpretation course
  • Basic understanding of how organisations work and the role of top management
  • Good knowledge of ISO 13485 and the quality management principles and concepts
  • Complete approximately 3 hours of pre-course work prior to attending the course.

What's included?

  • Training course materials
  • Lunch and refreshments for public attendees only

Your future development

Course length

Four days.

Book now View dates & locations

Prices from


Course Type

  • Public
  • In-house

Course length

In-house

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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