Medical Laboratory Quality Management Courses

ISO 15189 Assessor (Internal and External)

Who should attend?

Anyone interested in understanding the ISO 19011 guidelines and corresponding techniques for conducting Management System Audits (Evaluations) to determine conformance with ISO 15189 requirements.

Main Topics

  • Introduction to ISO 15189

  • Quality Management Principles

  • Measurement Uncertainty

  • Interpreting the ISO 15189 requirements

  • Fundamentals of Auditing (ISO 19011)

  • Auditor (Evaluator) Responsibilities

  • Audit Preparation

  • Audit Investigation - Case Study

  • Classification and Documentation of Audit Findings

  • Writing the Audit Summary

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

Learning Objectives

    • Understand the purpose and intent of the ISO 15189 Standard

    • Learn how to conduct ISO 15189 internal & external audits following ISO 19011 guidelines
    • Learn how to conduct audit interviews
    • Learn how to effectively communicate and report the audit results

Workshops

Includes practical workshops that help students achieve the Learning Objectives.

Course Duration: 24 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/IEC 15189 Documentation, Assessor &/ or Lead Assessor certificates by attending additional days of lectures & workshops during the same week. Contact your local IAR Representative for schedules & fees.

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