Medical Laboratory Quality Management Courses

 ISO 15189 Lead Assessor (Internal and External)

Who should attend?

All those responsible for Audit Program Management, ISO Management Representatives, ISO Coordinators, Consultants and anyone interested in learning the ISO 19011 guidelines for managing Internal and External Audit (Evaluator) teams, as well as the techniques for determining if a Management System conforms to the requirements of ISO 15189.

Main Topics

  • Introduction to ISO 15189

  • Quality Management Principles

  • Measurement Uncertainty

  • Interpreting the ISO 15189 Requirements

  • Management System Documentation

  • Audit Planning and Preparation

  • Audit Program Administration

  • Audit Investigation - (Case Study Simulation)

  • Classification and Documentation of Audit Findings

  • Writing the Audit Summary and the Final Audit Report

  • Audit Follow: Corrective/Preventive Action Close-Out Techniques

Course designed by experts that participate in the development of ISO Management System Standards

Learning Objectives

  • Learn how to correctly interpret the ISO 15189 requirements- including gray areas
  • Understand how to plan, prepare, conduct and report the results of the audit
  • Learn how to lead teams of Internal and External Auditors (Evaluators)
  • Understand the international schemes for Laboratory Accreditation


Includes practical workshops that help students achieve the Learning Objectives.

Course Duration: 40 Hours

Complete list of ISO/IEC 15189 Courses

Fundamentals of ISO 15189

ISO 15189 Documentation and Implementation

ISO 15189 Assessor

ISO 15189 Lead Assessor

Multiple Certificate Option:

Obtain the ISO 15189 Documentation, Auditor &/or Lead Auditor certificates by attending additional days of lectures & workshops during the same week. Contact your local IAR Representative for schedules & fees.

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