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ISO 15189:2003--quality management, evaluation and continual improvement.

David Burnett1

  • 1Lindens Lodge, Bradford Place, Penarth, UK. davidburnett4@btinternet.com

Clinical Chemistry and Laboratory Medicine
|May 30, 2006
PubMed
Summary

This study examines ISO 15189:2003 requirements using a quality management model focused on user needs. It highlights evidence, document control, and process management for continual improvement in medical laboratories.

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Area of Science:

  • Medical Laboratory Science
  • Quality Management Systems

Background:

  • ISO 15189:2003 provides standards for medical laboratory quality.
  • A process- and outcome-based quality management model centers on user needs.

Purpose of the Study:

  • To discuss ISO 15189:2003 requirements within a user-centric quality management framework.
  • To examine organizational and quality system aspects crucial for laboratory accreditation.

Main Methods:

  • Analysis of ISO 15189:2003 requirements.
  • Application of a process- and outcome-based quality management model.
  • Inclusion of examples from resource management and laboratory processes (pre-examination, examination, post-examination).

Main Results:

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  • Emphasis on the importance of evidence, document control, and control of records and clinical material.
  • Demonstration of how organizational structure and quality systems support ISO 15189 compliance.
  • Identification of key areas for evaluation and continual improvement.

    • Conclusions:

    • Adherence to ISO 15189:2003 is vital for robust medical laboratory quality management.
    • Continual improvement, driven by internal audits, external assessments, and management reviews, is essential.
    • A user-focused, process-based approach ensures effective quality in laboratory services.