Dates and Venues

Learn effective techniques and methodologies for auditing against ISO 15189 in medical laboratories on our ISO 15189 Internal Auditor training course.

This 2-day course employs interactive activities and workshops to encourage discussions with the tutor and other attendees and reinforce learning within the teaching environment.

Having attended this course delegates will have the skills to carry out internal audits against ISO 15189 to ensure continued compliance, determine improvements, professionally report findings, and implement corrective action programmes.

This course offers valuable insights for those involved in internal audits of medical laboratories. This includes:

  • quality managers
  • companies seeking ISO 15189 accreditation
  • certification/registrar/accreditation body auditors
  • existing internal auditors who wish to expand their skills in the area of laboratory practices
  • supplier quality auditors who need to evaluate clinical laboratory services

Please note that this ISO 15189 Internal Auditor course is designed to build upon delegates’ prior knowledge of ISO 15189. For those with little or no understanding of ISO 15189 we suggest first attending our Introduction to ISO 15189 training course (delivered the day before the Internal Auditor course). We offer a £100 discount when booking these courses together.

Topics covered by the course include:

  • the role of accreditation
  • introduction and review of ISO 15189:2022 requirements
  • quality and quality management principles
  • coordination of a management system audit using ISO 15189 (including the roles of the quality manager and internal auditors)
  • audit planning, horizontal, vertical and witness
  • checklist preparation
  • the concept of ‘risk-based’ auditing
  • effective auditing techniques and communication skills
  • witness/technical audits
  • reporting and grading of audit findings
  • preparation of summary reports
  • development and verification of effectiveness of corrective action

  • Day 1
    • WELCOME AND INTRODUCTION
    • Module 1 Course Structure
    • Module 2 Quality and Laboratory Accreditation
    • Module 3 Audit Overview
    • Module 4 ISO 15189 Requirements
    • Workshop 1 Audit Situations: Preparation
    • LUNCH
    • Workshop 1 Audit Situations: Feedback
    • Module 5 Documented Systems
    • Workshop 2 Documentation (preparation)
    • Module 6 Planning
    • Module 7 Checklists
    • Workshop 3 Checklists
    • Module 8 Case Study Introduction
    • CLOSE
  • Day 2
    • Module 9 Auditing Techniques
    • Workshop 4 Audit Interview
    • Case Study: Preparation and Questioning
    • LUNCH
    • Module 10 Nonconformity Reporting
    • Module 11 Closing Meeting
    • Module 12 Reporting
    • Workshop 5 Closing Meeting
    • Module 13 Corrective Action and Follow-up
    • Workshop 6 Corrective Action
    • Review and Course Evaluation
    • CLOSE

On completion of this course, delegates will be able to:

  • interpret the requirements of ISO 15189 as it relates to clinical laboratory operations
  • apply auditing principles and objectively assess the compliance of a laboratory and identify areas to improve competency and management systems
  • develop continuous improvement that provides on-going future benefits to the organisation