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The major functions of the Quality Assurance programme include designing the Quality Management System according to ISO 15189, ISO 15190 and ISO 17025 requirements, and the organisational policies; preparing and approving the Quality Management Procedures and allied documents to constitute the Quality Manual; reviewing the technical procedures and associated documents, approving them to constitute the Technical Manuals; implementing Quality Assurance Systems in the laboratories according to the procedures outlined in Quality Manual and requirements of the Technical Manual; implementing and maintaining Document Control System (review, approve, issue, obsolete, retain, and destroy); ensuring process evaluation and document review; and organising Laboratory Management Committee meetings with regular follow-ups and update.
An integral part of the programme Quality Assurance Office is to prepare training plans, carry out training needs assessment in different laboratories, and conduct training every year on QMS, ISO requirements, QSEs, and related issues. The Office follows up and investigates the Occurrence Report, Corrective/ Preventive Action, Complaints and Suggestions, and Risk Management Report, and log them for trend analysis. The Quality Assurance Office prepares the Internal QMS Audit Plan, forms and conducts trainings for the QMS Audit Team, prepares Audit Checklist, organises QMS Audit for the laboratories, and follow the audit observations and corrective actions. The Office also strives to ensure Proficiency Testing of laboratory services, implementing and measuring the indicators for continuous improvement. The Office is monitoring Good Laboratory Practices; resolving the discrepancies, and taking improvement actions. The ultimate goal of this programme is to implement and sustain QMS in LSSD laboratories and ensure ISO 15189 and ISO 15190 accreditation status of diagnostic laboratory services, and acquire ISO 17025 accreditation for other testing laboratory services. Additionally, the Office offers its essential quality assurance services to all the icddr,b facilities as needed to the extent feasible.