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Related Experiment Videos

Certification standards transfer: from committee to laboratory.

H P Lehmann1

  • 1Department of Pathology, LSU Medical Center, New Orleans, LA 70112, USA.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|February 19, 1999
PubMed
Summary

ISO 9001 provides a quality framework for manufacturing. This study examines clinical laboratory accreditation programs, like CLIA and CAP, for conformance to ISO 9001 quality standards.

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Area of Science:

  • Quality Management Systems
  • Clinical Laboratory Science

Background:

  • The ISO 9000 Standards series offers a quality framework for international manufacturing.
  • Section 4 of ISO 9001 details 20 quality system aspects for certification.
  • This quality system concept extends to clinical laboratories, ensuring patient/clinician confidence in test results.

Purpose of the Study:

  • To evaluate the applicability of existing clinical laboratory accreditation programs to ISO 9001 certification.
  • To determine the conformance of CLIA 1988 and CAP Laboratory Accreditation Program standards to ISO 9001, Section 4.

Main Methods:

  • Examination of the standards and checklists of CLIA 1988.
  • Review of the College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) standards and checklists.

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  • Comparative analysis against the requirements of ISO 9001, Section 4.

    • Main Results:

    • Clinical laboratory accreditation programs establish quality norms for customers (patients/clinicians).
    • Organizations require policies and procedures to ensure product quality and certification.
    • Independent accreditation agencies certify that laboratories meet defined standards.

    Conclusions:

    • Clinical laboratory accreditation programs, such as CLIA and CAP LAP, are crucial for ensuring quality.
    • Demonstrating conformance to ISO 9001 standards can be achieved through established accreditation processes.
    • Certification through recognized agencies validates a laboratory's commitment to quality and customer satisfaction.