In vitro diagnostics and laboratory technology

Quality assurance

The maintenance of a quality management system is crucial to a laboratory for providing the correct test results every time.

laboratory technician looking into a microscope
Quality assurance

Important elements of a quality management system include:

  • Documentation
  • Standard Operating Procedures (SOP's)
  • Quality Control samples
  • External Quality Assessment Scheme
Quality control

Are procedures used in each assay to assure a test run is valid and results are reliable:

  • Kit Controls
  • Quality Control Samples
External quality assessment schemes (EQAS)

Aims to analyse the accuracy of the entire testing process from receipt of sample and testing of sample to reporting of results (also known as proficiency testing)

Related links

Highlights

  • Newsletter Issue 10, Q2 2015
    pdf, 490kb

    This issue includes the new streamlined approach, abbreviated procedure, intersted in Ebola? Find our what the WHO PQ Dx team has been doing the field of Ebola Virus Disease (EVD) IVDs.

Events

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    The 2015 Joint WHO-UNICEF-UNFPA meeting with pharmaceutical and diagnostics manufacturers and suppliers will be held in Copenhagen during the week of 23-27 November
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Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int