Accreditation

Accreditation

Generally

GENvia, s.r.o. is accredited according to the international ISO norm No. 15 189 and is certified according the ISO norm No. 9001:2000 and the § 9 of the Act No. 296/2008 Coll.

The certification (ISO norm 9001:2000) says that the laboratory has established a quality system. It is the basic certificate, which can be issued by any certification company.

The accreditation (ISO norm No. 15 189) guarantees that the laboratory follows very strict quality requirements for examinations, including regular interlaboratory inspections, internal quality audits, calibration plan compliance, etc. The accreditation is granted entirely by ČIA, o.p.s. (Czech Institute for Accreditation).

The certification (§ 9 of the Act No. 296/2008 Coll.) ensures compliance with legislative requirements for the diagnostic laboratory, i.e. following strict conditions for preservation and handling of samples, personal data protection, regular service inspections of equipment, etc. The approval is granted entirely by SÚKL, o.p.s. (State Office for Drug Control).

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ČIA Accreditation

The laboratory GENvia, s.r.o. has been included among the accredited laboratories since 26.1.2006, when it obtained the Certificate of Accreditation and was included in the Central Registry of ČIA (Czech Institute for Accreditation) under the No. M 8006 (ČIA-registry).

The results issued by the laboratory GENvia, s.r.o. are labelled with the ČIA-mark and the laboratory number M8006, which demonstrate assurance of the highest quality of testing performed and the meeting of all requirements set in the international ISO norm No. 15 189 for clinical examinations.

 



 

Since July 7, 2015 the laboratory applied to the selected methods flexibility, within which there was a modification of selected methods in the exactly specified range.

 

List of methods accredited by ČIA, o.p.s. (Czech Institute for Accreditation):

  • Cytogenetic determination of the karyotype from the amniocytes of the amniotic fluid
  • Cytogenetic determination of the karyotype from the fetal and peripheral blood
  • Cytogenetic determination of the karyotype from the chorionic and aborted tissue
  • Testing for aneuploidy, microdeletions and chromosomal rearrangements in cultured and uncultured cells of blood, amniotic fluid, tissue and blastomeres using FISH method
  • Detection of mutations in the CFTR gene (cystic fibrosis)
  • Detection of microdeletions of the AZF area on the Y chromosome
  • Detection of thrombophilic mutations (Factor V Leiden, Factor II Prothrombin, MTHFR C677T and MTHFR A1298C)
  • Molecular genetic analysis of chromosome aneuploidy 13, 18, 21, X and Y QF PCR method – podrtžený text smazat (PCR amnio)
  • Detection of polymorphism UGT1A128 conditioning formation of Gilbert’s syndrome

Podrobnosti o jednotlivých vyšetřeních naleznete v sekci Laboratoř

SÚKL Certification

GENvia, s.r.o. ensures compliance with the requirements for diagnostic laboratories, according to the § 19 paragraph 2 of Act 296/2008 Coll., as amended. The State Office for Drug Control (SÚKL) allowed the diagnostic laboratory business under Decision No. sukls124246/2019 dated 12.6.2019 and included the laboratory in the Central Registry of holders of permission to operate in the area of human tissues and cells (SÚKL database).

 


 

Overview of methods certified by SÚKL (State Office for Drug Control):

  • Cytogenetic karyotype determination from peripheral blood
  • Detection of mutations in the CFTR gene