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Department for Quality Assurance and Control

dr Sanela Dostović Halilović, specialist transfusionist
e-mail: sanela.dostovichalilovic@ztmfbih.ba
Vlado Miličić- medical technician
e-mail: vlado.milicic@ztmfbih.ba
Contact telephone: +387 33 567 317

The FBiH Institute for Transfusion Medicine, in compliance with the Law on Blood and Blood Components (Official Gazette of FBiH No. 9/10), the modern transfusion doctrine, the principles of good laboratory practice and good manufacturing practice, established the Department of Quality Assurance and Control in 2011.
In December 2011, the Project for the Establishment of Quality Management System according to the requirements of ISO 9001 started. Understanding the establishment of the system as a significant support in raising the quality, safety and security of the process of work and blood products, the Department conducts activities on their maintenance and continuous improvement through:

  • Proposals for Quality Policy.
  • Suggesting guidelines and solutions related to the quality management system
  • Quality planning at the level of European directives, applicable legal regulations and professional standards.
  • Organizations producing, editing, and managing document quality management documentation. Quality system documents are needed for effective planning, execution, management, and oversight of processes and actions. Documents are periodically evaluated and updated. Appropriate editions of valid documents are available at the places of use, and outdated documents are pulled.
  • Creating and monitoring the realization of the Program and the goals of the Quality Improvement System.
  • Planning, organization and participation in the implementation of internal quality management systems. The quality assessment is an independent and documented verification to determine whether the quality activities and results are consistent with planned and established requirements and procedures, whether the procedures are appropriate for achieving the set quality objectives and are effectively implemented. The annual level plan, organizes and performs internal quality system evaluations at least once a year in each section.
  • Blood quality control organizations that are fully aligned with the requirements of the EU Directive and Recommendations for the Production, Application and Quality Assurance of Council of Europe No.R (95) 15, as its technical standard. All activities in the quality control of blood products are performed according to quality plans and specifications of blood products, and all activities are described in the operating instructions. Blood quality control includes:
    1. control of hematological parameters
    2. microbiological control
    3. determining the pH value
    4. determination of hemolysis in erythrocyte blood preparations
    5. Residual cells in plasma and blood-reduced leukocyte preparations
    6. Determination of coagulation factor (VIII) in fresh frozen plasma
  • Error handling and reclamation.
  • Non-conformities management across all segments of activity that is reflected in defining non-conformance as any deviation from specified requirements, operating instructions, and procedures, including errors and accidents. This means that, with unsuitable products, it records, reports, analyzes and fails punctuation, bad brew, equipment and equipment error, input material, unmodified sample, and etc.
  • Managing Returned Products.
  • Reversal of traffic products.
  • Implementation of "trace-back" and "look-back" procedures.
  • System Review and Management Reporting of the Office on the Effectiveness of the Quality Management System and all the needs for improvement.
  • Proposing corrective and preventive measures, coordinating their implementation and verifying achievements.
  • Monitoring the achievement of the Institute's quality objectives.
  • Approvals and controls over the implementation of change control and validation. Change control is a system for evaluating, documenting, approving and introducing new input materials, processes, equipment and testing in a controlled and coordinated manner. It is also a system that controls the changes of input materials, processes, space, equipment, laboratory testing, and product quality control to ensure the appropriate product quality and the durable validated status of the system to which the change relates. Validation is a documented evidence demonstration that provides a high degree of security that any process, equipment, material, activity, or system will yield a result / product that has predetermined specifications and quality attributes.
  • Management of working conditions.
  • Organizations and training of employees in the field of quality management.
  • Organizing and conducting professional work inspections at the Institute.
  • Communicating with key users of ZTM FBIH services and products related to issues related to the quality management system. By conducting a test of the satisfaction of the users of the products and services of ZTM FBIH, through exchange of opinions, clarification of the procedures used and etc, we encourage cooperation with users of products and services. Every feedback on the quality of products and services is utilized by the ZTM FBIH in the process of assessing user satisfaction and developing good partner relationships with users of services and products.
  • Creating awareness of user requirements at all levels in the Office.
  • Collection of data on serious adverse reactions and serious adverse events (hemovigilance) related to collection, production and

The certification verification is performed by Bureau Veritas Certification.