Haemostasis V.
[Hemosztazeológia V.]
EPTIS factsheet 1257415 | Last revision 2026-03-19 | URL: https://www.eptis.bam.de/pts1257415 https://www.eptis.bam.de/pts1257415
| PT provider | |||||||||||||
| PT provider | QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. | ||||||||||||
| Based in | Hungary | ||||||||||||
| Language(s) | English, Hungarian | ||||||||||||
| Remarks | The evaluation is based on the device and the reagent. QualiCont has had accredited status as the QualiCont as a Proficiency Test Provider complies with the criteria of MSZ EN ISO/IEC 17043:2010 standard since 26 March 2014. The QualiCont has been accredited according to the MSZ EN ISO/IEC 17043:2023 standard since 18 December 2025. Our Company is a Proficiency Testing Provider Organisation accredited by NAH (National Accreditation Authority) under the NAH-8-0002/2023 registration number. As the result of the accreditation process performed by NAH, our Company has accredited status until 9 March 2028. QualiCont Nonprofit Kft. has been operating its quality management system since 2001. Our Company successfully passed the renewal audit on 6th May, 2025. The certificate is valid until 28 May 2028. Our Company has been assessed and certified as meeting the requirements of ISO 9001:2015 standard for the following activities: Planning, organization and management of proficiency testing (external quality assessment) and the related supporting services for in vitro medical diagnostic laboratories and investigators on other human and veterinary medicine. | ||||||||||||
| Keywords | |||||||||||||
| Product groups |
Health care / medical devices
Human test material |
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| Testing fields |
Medical analysis
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| Technical details | |||||||||||||
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| Aims of the PT scheme | |||||||||||||
| Target group of participants | In vitro medical laboratories | ||||||||||||
| Linked to specific legislation / standards | CLSI GP44-A4 – Procedures for Handling and Processing of Blood Specimens for Common Laboratory Tests ILAC_G8:09/2019 – Guidelines on Decision Rules and Statements of Conformity ISO 15189 – Medical laboratories – Requirements for quality and competence ISO/TS20658:2017 – Medical laboratories – Requirements for collection, transport, receipt and handling of samples VIM3 – Vocabulaire International de Métrologie WHO – Guidance on regulations for the Transport of Infectious Substances | ||||||||||||
| Additional, subsidiary aims | validation of testing methods | ||||||||||||
| Number of participants | |||||||||||||
| Accredited or otherwise reviewed by a 3rd party |
Accredited by NAH (National Accreditation Authority) on the basis of ISO/IEC 17043:2010 |
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| Operation is commissioned / requested by | |||||||||||||
| Fees and frequency | |||||||||||||
| Participation fee | on demand | ||||||||||||
| Regularly operated | Yes (four times a year) | ||||||||||||
| Year of first operation | 2003 | ||||||||||||
| Contact details of the PT provider | |||||||||||||
| Provider | Contact person | ||||||||||||
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QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Feketesas u. 19-21. I/7 6720 Szeged Hungary Phone: +36 30 462 5864 Fax: Web: http://www.qualicont.com/qc/index_en.html http://www.qualicont.com/qc/index_en.html |
Ms. Eszter Mezey
Phone: +36 30 462 5864 Fax: Email: mail@qualicont.com mail@qualicont.com |
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If you find any mistakes please contact the responsible EPTIS coordinator in Hungary,
Ms Eszter Mezey.
Ms Eszter Mezey.