About this module
Can I trust the result of molecular test performed on FFPE slides? How can we improve our work to have reliable results? What about regulations and standards such as IVDR and ISO norms. Through the module Quality Control we answer Quality control and Quality assurance is not just a theoretical concept, but can have a concrete impact on people’s live. Society sets high expectations around quality and safety and so the authorities increasingly impose obligations regarding quality assurance in laboratories, healthcare organizations or companies.
This requires not only professional and administrative adjustments. It is an integral process that requires the involvement of all employees in an organization. In practice, short-term improvement regularly proves successful, but permanent improvement is a seriously difficult challenge.
Learning outcomes
By the end of this module, the learners should be able to:
- Gain an overview of the quality ISO standards and EU regulations for getting started in his/her organization
- Examine the key clauses of these standards and regulations
- Understand the importance of quality management systems and examine the responsibilities of to create a quality culture in the laboratory
- Identify the steps for defining, organizing and scheduling necessary quality activities such as external quality assessment, validation of methods
Module coordinators
- Pr Elisabeth Dequeker
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Professor Elisabeth Dequeker is Master in Chemistry (M.S.) and Doctor (Ph.D.) in Science (Organic Chemistry) from the University of Leuven (Belgium). Since her postdoctoral research, she specialized in Quality Assessment aspects of medical diagnostic laboratories. She is currently full professor and Head of the Biomedical Quality Assurance Research Unit (University of Leuven) and Head of the Quality Department and Regulatory Affairs Officer for Medical Diagnostics at the University Hospitals Leuven.
Prof. Dequeker has been active for more than 25 years in the field of quality management in medical laboratories, where she is an internationally recognized expert and key opinion leader. She built a strong reputation as initiator and organizer of large international external quality assessments (EQA) in diverse disease areas, and published groundbreaking manuscripts from associated research on EQA outcome data.
In her role as Head of the Quality Department of Medical Diagnostics at the University Hospitals Leuven she is responsible for the strategy and coordination of the overall quality management system across the Medical Diagnostics division. She oversees the implementation of the quality management system as well as the validation and verification of new tests and instruments used, including in vitro diagnostic (IVD) tests.
As certified auditor for ISO-15189, ISO-17025 and ISO-17043, prof. Dequeker regularly performs audits on behalf of the Belgian accreditation authority BELAC and other members of the European Accreditation Cooperation.