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Laboratory quality management system; handbook
  • Published Date:
Filetype[PDF-3.61 MB]

  • Corporate Authors:
    World Health Organization ; National Center for Preparedness, Detection, and Control of Infectious Diseases (U.S.), Division of Laboratory Systems. ; Clinical and Laboratory Standards Institute
  • Description:
    Acknowledgements -- Foreword -- Key words -- 1. Introduction to quality -- 2. Facilities and safety -- 3. Equipment -- 4. Purchasing and inventory -- 5. Process control--sample management -- 6. Process control--introduction to quality control -- 7. Process control--quality control for quantitative tests -- 8. Process control--quality control for qualitative and semiquantitative procedures -- 9. Assessment--audits -- 10. Assessment--external quality assessment -- 11. Assessment--norms and accreditation -- 12. Personnel -- 13. Customer service -- 14. Occurrence management -- 15. Process improvement -- 16. Documents and records -- 17. Information management -- 18. Organization -- Glossary -- Acronyms -- References and resources by chapter -- Notes

    "Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents." - p. 7

    "This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. " - p. 6

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