License
The Company's operations in the Republic of Armenia have been carried out since 2026 under a license issued by the Ministry of Health of the Republic of Armenia.
The College of American Pathologists (CAP) Certificate of Laboratory Diagnostic Quality Standards
In 2019, Helix was the first in the CIS to receive the Certificate of The College of American Pathologists (international certificate of quality standards for laboratory diagnostics from The College of American Pathologists) and was included in the list of the best laboratories in the world.
The CAP certificate is issued on the condition that the Company's activities fully comply with over 3,000 requirements developed with the assistance of 500 laboratory diagnostics experts.
Sigma-metric Performance from the American Company Westgard QC, Inc.
In 2018, the Helix Laboratory Service was certified according to the worldwide standard Sigma-metric Performance by the American company Westgard QC, Inc. Verification is carried out according to the Six Sigma program
This verification indicates that research performance errors are statistically possible in only 3.4 cases out of one million.
ISO Quality Management System Certificates
ISO 15189:2012
In 2014, the Helix Laboratory Service became the first commercial Russian laboratory to receive an ISO quality certificate 15189:2012.
Since then, the Company annually undergoes a certification audit for compliance of the management system with the international standard ISO 15189:2012 "Medical multidisciplinary laboratory services". The certification body is Global Group (UK).
Status of the Roche Diagnostics Reference Laboratory
In 2018, the Company was the only one in the CIS to receive the status of a Roche Diagnostics reference laboratory. This means compliance with a high level of analytical quality and production process design, which is regularly confirmed on a worldwide scale.
EQAS (Bio-Rad, USA) and RIQAS (Randox, UK)
The Helix laboratory regularly participates in two international systems for assessing the quality of laboratory tests: EQAS (Bio-Rad, USA) and RIQAS (Randox, UK). According to Bio-Rad, Helix is consistently ranked as one of the BEST laboratories worldwide using similar equipment.
Diagnostic Center Licenses
The activities of Helix Diagnostic Centers in Armenia are carried out on the basis of licenses issued by the Ministry of Health of the Republic of Armenia.
Licenses and certificates
The College of American Pathologists (CAP) Certificate of Laboratory Diagnostic Quality Standards
Sigma-metric Performance from the American company Westgard QC, Inc.
ISO Quality Management System Certificates
Status of the Roche Diagnostics reference Laboratory