Accreditation

Certagen GmbH is accredited by the DAkkS according to EN ISO/IEC 17025.

Field

veterinary medicine

Test Field

genetics

Scope

Polymerase Chain Reaction (PCR)
Fragment-Length-Polymorphism (FLP)

This covers all tests for parentage- and identity control, as well as all tests on hereditary traits like color inheritance or predispositions for genetic diseases.

Laboratories, which want to comply with this normative, must implement fixed demands regarding organisation (e.g. reproducibility, complaint management etc.) as well as in the technical field (e.g. equipment, staff, methods etc.).

What does this accreditation mean?

Traceability

All documents, produced in processing of the orders (e.g. order forms, also technical records) must be archived in a clearly defined way. By this means, it is still traceable after years, which member of our staff analysed the respective sample when on which machine and which distinctive feature have been observed.

Accuracy

We must prove the accuracy of our assessments withdrawn out of our tests regularly. As a rule, we do this by annual laboratory comparison tests. In these laboratory comparison tests, the participating labs exchange samples, test them independently and compare the respective results. We can only keep our accreditation, when we are able to prove in these tests, that our procedures provide accurate results.

Test reliability

We must prove regularly that our tests provide accurate and to the normative corresponding results by internal revisions of order processing and working processes (at least annually, so called audits), and by revisions by independent external experts (every 18 month). In doing so, we demonstrate that the laboratory complies completely with the normative, including order processing and reporting.

Furthermore, Certagen is appointed by ICAR (international Committee for Animal Recording) as one of 12 laboratories worldwide (last update: Feb, 10th 2012), and by the French ministry of agriculture for Parentage testing in cattle.

The barriers in getting the respective appointments are comparable high as for the ISO accreditation:

While ICAR emphasises the quality of every staff member, the regularly performed diagnostic tests, and the control of the significance of the tests very much, the French ministry of agriculture make great demands on the quality and significance of the individual procedures, in the regular inspections difficult samples are intentionally tested.

That all demonstrates our clients:

Reliable results of a professional service provider.

see also:

Accreditation certificate (PDF)

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