Since January 16, 2010, legislation relating to medical biology has required the establishment of accreditation for all medical biology laboratories (LBM) in France. All public and private LBMs must be accredited on their entire activity no later than October 31, 2020. Accreditation is based on standard NF EN ISO 15189, completed for biological examinations relocated by standard NF EN ISO 22870. These standards are mandatory in France.
Be at your side
In its range, the IBJB develops and offers products and services that support your accreditation process by validating certain criteria:
- by using our IQC in immuno-hematology, independent of the manufacturers of PLCs and reagents, you respond to the Professional recommendations and regulatory requirements: "The use of IQC of independent origin of the pair devices / reagents is the most recommended to independently ensure effective internal control quality" (Giannoli JM, Szymanowicz A. Proposed recommendations for the practical use of internal quality controls (IQC) in a laboratory of medical biology Ann Biol Clin 2011; 69 (4): 489-98 doi: 10.1684 / abc.2011.0606) ; "The use of independent third-party controls, instead of or in addition to the control materials provided by the reagent or instrument manufacturer" - paragraph 5.6.2.2 (Technical Requirements / Quality Assurance of Results / Quality Control) of ISO Standard 15189: 2012 specifying quality and competence requirements for LBMs
- using our K-Matic coloring machine for your Feto-maternal quantification, you secure and accelerate the staining steps of blood smears, which is further improved by accessories such as the blade spreader. For the installation of this equipment, we accompany you and give you the means to validate, in the terms envisaged by the standard, the material and the analytical processes. This range is in line with the requirements of NF EN ISO 15189: 2012.
- by proposing an External Quality Certification (CEQ) program in IH and for the Kleihauer technique, IBJB supports you in the validation of accreditation criteria for your blood grouping and maternal-fetal quantification techniques.
useless links: https://www.cofrac.fr/fr/activites/sante.php https://www.cofrac.fr/fr/cofrac/processus.php
