Quality management
Related Items
- KIT Dossier Laboratory Quality Strengthening
- KIT Information Portal Laboratory Quality Strengthening
- Laboratory capacity building
- Course Quality System Management for Diagnostic Laboratories
KIT Biomedical Research has an CCKL accredited quality system for its WHO/FAO/OIE Reference Laboratory for Leptospirosis based upon the ISO 15189 standard for medical laboratories ('Particular requirements for quality and competence of medical laboratories'). We use this expertise and experience to support human resource and institutional development and training development in low and middle-income countries KIT.
Approach
KIT Biomedical Research is currently developing a course in Laboratory Quality Management, the introductory module of of which has already been given in Uganda and Tanzania. KIT is also in the process of developing a staged quality system adopted to the needs of all levels of laboratories (from peripheral to reference laboratory).
We can assist organizations in setting up a quality system in their laboratory and guide them to eventual certification or accreditation. We can provide on the spot training sessions for all personnel, assist in developing an action plan and provide guidance and support in the execution of the plan. We also can provide formats for quality handbooks, SOPs, audits, etc.
KIT actively participates in international initiatives on laboratory strengthening (for example with WHO), from assisting in developing policies to implementing principles of quality in laboratories.
Focal points
KIT Biomedical Research's expertise includes:
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Basics of quality
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Auditing systems
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Development of SOPs, guidelines, criteria and standards
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Development of quality handbooks
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Documentation
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Proficiency testing
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Laboratory upgrading
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Laboratory management
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Epidemiology/statistics at the service of diagnosis
Example
- Training and assistance for TB laboratories in sub-Saharan Africa for the introduction and implementation of quality management
- Institutional capacity strengthening (both HRD and infrastructure) for the performance of clinical trials according ICH-GCP (Rwanda/Uganda)
- Organization and Quality Assurance of TB Laboratory Services (Egypt)
- Setting-up, organizing, staffing, managing and evaluating diagnostic laboratories, including the integration of these facilities into the public health system ( Russian prison system)
- Preparation of a program to upgrade the Central Laboratory of Bureau for Public Health of Surinam, including technical, personnel, managerial and financial aspects
- Advice on restructuring the health system, in particular the diagnostic facilities plus evaluation of the current health situation in Mongolia
- Introducing the ISO15189 quality standard in Oeganda for the central tuberculosis reference laboratory and assisting in introduction of quality standards in peripheral laboratories