Assessing and monitoring the performance of medical and veterinary laboratories
Our service is responsible for assessing and performing quality controls in medical and veterinary laboratories in Belgium. We perform medical laboratory controls in two ways: external quality assessments, on the one hand, and the official recognition of these laboratories by the granting of an approval, on the other hand. We are also experts in quality control of in vitro diagnostic medical devices.
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External Quality Assessments
We organise a mandatory external quality assessment programme in various fields covered by veterinary laboratories, medical laboratories for clinical biology and pathological anatomy. Our objective assessments are based on robust statistical calculations and aim to constantly improve the quality of laboratory analyses. These assessments enable laboratories to assess their own results and to compare their methods with those of other laboratories. Due to the rapid evolution of this field, we adapt our external quality controls on an ongoing basis and inspect approved laboratories on the basis of innovations, scientific knowledge, methods and technologies.
Medical Laboratory Approvals
Approval is granted only if all legal quality requirements are met. As part of the approval, the missions of our service also include conducting on-site inspections.
Quality control of in vitro diagnostic medical devices (IVD)
An “in vitro diagnostic medical device” is a product used for the purpose of providing medical information, from a sample taken from a patient. In support of the Federal Agency for Medicines and Health Products (FAMHP), which is the competent authority for the registration of in vitro diagnostic devices (IVD) placed on the market by Belgian manufacturers and agents, we can provide our expertise in particular in case of non-conformity of the product or in the event of an incident. We can analyse the nature and risk of the problem and check that all corrective actions have been taken and implemented. IVDs must comply with legal requirements. As they are products subject to the CE marking, IVDs can circulate freely in Europe, which also explains the far-reaching cooperation with the competent authorities of the other Member States and with the European Commission.
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Request for an external quality control
We have a long and solid experience in the quality control of medical and veterinary laboratories and their approval.