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GENTIS receives ISO 15189:2012 Certification for GenEva, NIPT, PGT A and SLSS Thalassemia services

Created date : 15-09-2023
Updated date: 15-08-2024
Author: Gentis
On September 14, 2023, at Genetic Analysis Services Joint Stock Company (GENTIS), the Accreditation Certificate Ceremony of maintaining ISO 15189:2012 for GenEva services and expanding ISO 15189:2012 for 3 services: NIPT, PGT A, Thalassemia Neonatal Screening was held solemnly and warmly.
Main content

The ISO 15189:2012 accreditation certificate is assessed and issued by the Bureau of Accreditation (BoA) under the Ministry of Science and Technology of Vietnam. This is the top quality standard that is being applied by laboratories all over the world.

Attending the ceremony were representatives of the Bureau of Accreditation: Ms. Tran Thi Thu Ha - Director of BoA and Ms. Quach Hoang Lan - General Administration Department of BoA. On the side of GENTIS, there were Mr. Do Manh Ha (General Director of GENTIS), Colonel Ha Quoc Khanh (Former Director of the DNA Testing Center - Institute of Criminal Sciences; Former Deputy Director of the Institute of Criminal Sciences - Ministry of Public Security; Senior Scientific Advisor of GENTIS), Mr. Nguyen Quang Vinh (Director of GENTIS Laboratory Center) and managers,...

Mr. Do Manh Ha - General Director of GENTIS received the ISO 15189:2012 accreditation certificate from Ms. Tran Thi Thu Ha - Director of the Bureau of Accreditation (BoA)

In the medical field, the quality of tests plays a crucial role in helping doctors screen, diagnose and provide the most effective treatment for patients. Accurate testing helps doctors diagnose and treat the correct disease, help patients save costs and shorten treatment time and take the right drugs. This further motivates laboratories to develop quality management systems and improve their capacity and techniques to meet ISO 15189:2012 standards.

The event of GENTIS receiving the Certificate of Accreditation continues to maintain ISO 15189:2012 for GenEva services and expands ISO 15189:2012 for 3 services: NIPT, PGT A, Thalassemia Neonatal Screening once again affirms the quality of safe and effective testing services for Vietnamese citizens.

ISO 15189:2012 is a system that guides the control of all 3 stages before, during and after of the testing process and issues related to testing, bringing officials to perform quality control tests complying to a mandatory procedure. The application of ISO 15189:2012 standard is a reliable basis to help doctors when offering the most appropriate and effective treatment method for patients.

It’s such an honor for GENTIS to receive the Accreditation Certificate of maintaining ISO 15189:2012 for GenEva service and Accreditation Certificate of expanding ISO for 3 services: NIPT, PGT A, Neonatal screening of Thalassemia

In addition, the application of ISO 15189:2012 standards also helps test processes to be standardized, implemented synchronously, consistently, scientifically and correctly from the starting point to ensure quality. Moreover, it promotes strictly fulfilling the commitment of safe sample taking, returning results as soon as possible and keeping customer information confidential.

To achieve ISO 15189:2012, GENTIS must meet a lot of requirements in terms of management capacity, equipment, personnel competence and process compliance.... This is a testament to the reliability of the GenEva, NIPT, PGT A and Thalassemia Neonatal Screening tests at GENTIS. The ISO 15189:2012 Accreditation Certificate is the result of the efforts of the staff of GENTIS testing center and related departments on the way to standardize the testing system. Not only that, GENTIS also focuses on building a quality assurance management and inspection system through internal and external inspection programs.

Speaking at the opening ceremony, Ms. Tran Thi Thu Ha - Bureau of Accreditation (BoA) said: "ISO 15189:2012 accreditation is a process of striving and efforts of Genetic Analysis Services Joint Stock Company. However, maintaining accreditation also requires the Company to continue to make further efforts to maintain its capacity, techniques, as well as maintain the quality system. Not only maintaining, we also hope that the Company will continue to expand testing criteria to better serve patients and improve the quality of the company's services.

ISO 15189:2012 Accreditation Certificate is the motivation for GENTIS to make more efforts in the process of quality improvement

Speaking at the ceremony, Mr. Do Manh Ha (General Director of GENTIS Company) shared: "The process of quality improvement is a non-stop development process, which must be continuously improved. On the path of development, GENTIS relentlessly improves to bring the best quality to tests, as well as bring the best values to customers and partners. GENTIS will continue to pursue and develop to achieve more certifications, not only ISO 15189:2012 for some existing products, but will do more products in the future. In addition, GENTIS will continue to pursue higher certifications."

Also at the ceremony, Colonel Ha Quoc Khanh (Former Director of the DNA Testing Center - Institute of Criminal Sciences; Former Deputy Director of the Institute of Criminal Sciences - Ministry of Public Security; Senior Scientific Advisor of GENTIS) shared: "Product value is evaluated by the standards that are recognized as the best. The GENTIS professional team will try its best to maintain the recognized standards and expand further to meet the development needs of society and the community."

Up to now, GENTIS has achieved ISO 15189:2012, ISO 9001:2015 and ISO 13485:2016 standards. This further confirms that GENTIS is a pioneer in the field of genetic analysis, with the desire to help customers enjoy the best and most professional testing services.

With this quality affirmation, GENTIS hopes that Vietnamese people can easily take advantage of the quality of high-tech testing. At the same time, GENTIS hopes to contribute more to people's health care in terms of convenient on-site sampling services through cooperation with doctors, clinics, centers, and hospitals across the country.

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