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1

GENTIS receives a delegation of Auditors to monitor and expand ISO 15189:2012

Created date : 13-07-2023

Updated date: 22-08-2023

Author: Gentis

On July 10 - 12, 2023, GENTIS was honored to welcome a delegation of Auditors from the Office of Quality Accreditation (BoA) to conduct the NIPT test monitoring assessment and the criteria to expand the package. NIPT tests (such as PGT-A, Thalassemia, ...) according to ISO 15189:2012 for GENTIS International Laboratories. This event marked the development of the capacity and quality assurance management system in GENTIS testing operations.

The meeting had the presence of Ms. Nguyen Hong Nhung - Quality Assessor, Quality Accreditation Office as Head of the Evaluation Team and Mr. Duong Quoc Chinh - Hematology Technical Evaluation Specialist, Institute of Hematology Transfusion. Central Blood and GENTIS leadership representatives, all staff of GENTIS international laboratory and ISO department of GENTIS.

According to the assessment program, from July 10 to 12, 2023, the assessment team worked directly at the office and the GENTIS International Laboratory to conduct surveillance assessment of NIPT testing, the indicators. extended to NIPT test packages according to ISO 15189:2012.

The audit team examined the records related to the application and development of the quality management system according to the ISO 15189:2012 certificate issued for the NIPT test. At the same time, extensive evaluation for NIPT test packages meets ISO 15189:2012 standards. As follows:
• Management requirements (4.1 – 4.15)
• Technical requirements (5.1 – 5.10)
• Management requirements (4.3; 4.9; 4.13)
• Technical requirements (5.1 – 5.10)
• Observing test indicators
• Observe sampling, transport and receiving samples.
• Observe the result reporting system
The meeting took place in an atmosphere of urgency and seriousness. At the end of the meeting, Ms. Nguyen Hong Nhung - Head of the assessment team made some comments as follows: GENTIS complies well with the standard requirements of the system.
Through the evaluation of NIPT testing supervision and the expanded criteria for NIPT test packages according to ISO 15189:2012, GENTIS has demonstrated to the expert team its ability to fully satisfy in quantity and quality. quality standards including facilities, personnel, equipment, quality management system in accordance with the regulations of the Laboratory.
The evaluation and supervision of NIPT testing and the expanded criteria for NIPT test packages according to ISO 15189:2012 standard in order to improve the capacity of GENTIS International Laboratories, ensure better service quality for customers. The final conclusion of the surveillance and quota expansion was that the GENTIS International Laboratory met the requirements for maintaining accreditation according to ISO 15189:2012.

On behalf of GENTIS Company, Mr. Nguyen Quang Vinh - Director of the Testing Center expressed his thanks and received the comments of the evaluation team so that GENTIS could perfect, as well as further develop the system, to improve the quality of the work. working in the areas of operation of the GENTIS International Laboratory.