Laboratory quality management, quality norms and standards, validation.

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.

• Knowing the basic principles of quality management and validation systems.
• Knowing the jurisdiction of national and international institutes for quality care.
• Knowing the criteria and procedures for accreditation of (belgian) laboratories.
• Knowing the procedures for validation of methods and results in the biomediacl sector.
• 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 laboratories.
• To bear in mind national and international laws and legislation while developing, planning, coordinating, executing and following up scientific research.
• 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.

Personally (on appointment)

Classroom lectures; Microteaching

Evaluation during examination period

During examination period: written closed-book exam