Laboratory quality management, quality norms and standards, validation.
Position of the Course
The student becomes acquainted with the general principles of quality management and their application in laboratories, with the legally recognized G(ood) L(aboratory) P(ractices), the principles of accreditation of laboratories, and the repercussions on the design of laboratories and their future perspectives.
- General principles of quality management systems and their application within chemical and medical laboratories.
- Summary of national and international institutes for quality care.
- Aims, development and contents of national and international standards for guaranteeing quality in the biomedical industry, research and services.
- Accreditation, certification and GLP-legitimation in Belgian laboratories: criteria, documents, procedures, implementation, audits, costs, national and international legislation.
- European guidelines for medical equipment.
- Validation of methods and results in laboratories.
- Practical use of the ISO 9001:2000 process model for quality management.
Having successfully completed the courses Data-analysis I: mathematical principles and Data-analysis II: biomedical statistics from the bachelor program biomedical sciences, or having acquired the relevant ending objectives by other means.
Teaching and Learning Material
Knowing the basic principles of quality management and validation
Knowing the jurisdiction of national and international institutes for
Knowing the criteria and procedures for accreditation of (belgian)
Knowing the procedures for validation of methods and results in the
Knowing the requirements of conformity of medical equipment according
to EU directives.
Having the attitude to stay correctly informed about recent
developments regarding standardization and normalization in
To bear in mind national and international laws and legislation while
developing, planning, coordinating, executing and following up
To possess the attitudes and skills to work and to report efficiently,
orderly and well organized, to inform, to critically evaluate research
results, to make justified and correct conclusions, to argue and
motivate personal decisions.
Syllabus (Dutch), supplemented with official documents concerning quality management in laboratories and accreditation, available on internet. Estimated cost: 10 euros.
Course Content-Related Study Coaching
Personally (on appointment)
Classroom lectures; Microteaching
Evaluation during examination period
During examination period: written closed-book exam