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On August 13, 2024, GENTIS, the Genetic Analysis Services Joint Stock Company, held a formal ceremony to receive the ISO 15189:2022 Quality Management System certification and the ISO/IEC 27001:2022 Information Security System certification for the GENTIS EUROFINS Laboratory.
- The ISO 15189:2022 VILAS MED 101 certification was assessed and granted by the Bureau of Accreditation (BoA) under the Ministry of Science and Technology of Vietnam.
- The ISO/IEC 27001:2022 certification was assessed and granted by the global professional certification organization Guardian Independent Certification LTD (GICG).
Representatives from the BoA and GICG attended the ceremony
The event was attended by representatives from the Bureau of Accreditation, including Mr. Đặng Quốc Quân, Deputy Director of the office, and Ms. Trần Thị Huyền Trang, Evaluation Specialist. Representatives from the global professional certification organization included Mr. Đặng Minh Tuấn, Director of the company, Mr. Nguyễn Hồng Diệp, Head of Evaluation Department, and Mr. Nguyễn Quốc Chiến, Evaluation Specialist. GENTIS representatives included Mr. Đỗ Mạnh Hà, General Director of the company, Mr. Hà Quốc Khanh, Quality Management Representative, and other management officials.
At the ceremony, Mr. Đặng Quốc Quân, representing the Bureau of Accreditation, expressed: “Achieving ISO 15189:2022 certification marks the beginning of a new journey, requiring continuous effort and determination from the entire GENTIS team to implement quality management. This spirit must be maintained and spread to every employee to fully realize and enhance the benefits that ISO 15189:2022 brings.”
ISO 15189:2022 - The "Gold Standard" for medical laboratories
ISO 15189 is a set of standards outlining the requirements for the quality and competence of medical laboratories. The standard has gone through three versions: ISO 15189:2003, ISO 15189:2007, and ISO 15189:2012. On December 8, 2022, the International Organization for Standardization (ISO) officially issued the fourth version of the standard, ISO 15189:2022.
The ISO 15189:2022 certification is an international standard specifically designed for medical laboratories, ensuring that laboratories operate with the highest levels of accuracy, reliability, and confidentiality. ISO 15189:2022 reflects developments and advances in the field of medical testing, emphasizing risk management, continuous improvement, and integrating quality management into all aspects of laboratory operations.
Mr. Đặng Quốc Quân, representing BoA, presented the ISO 15189:2022 certification to Mr. Đỗ Mạnh Hà, General Director of GENTIS
ISO/IEC 27001:2022 - A commitment to strict and secure information protection
ISO/IEC 27001:2022 is also the latest version of the international standard for information security management. This standard sets out specific requirements for establishing, implementing, maintaining, and continuously improving an Information Security Management System (ISMS).
The 2022 version of this standard includes several updates and improvements over the previous version (2013) to reflect changes in the global information security landscape and emerging threats. The goal of ISO 27001 is to protect the confidentiality, integrity, and availability of information by applying comprehensive risk management measures.
At the ceremony, Mr. Đặng Minh Tuấn, Director of GICG, shared: “The information security system according to ISO 27001:2022 standards will help the organization control and guide activities to ensure cybersecurity and protect customer information. GICG is also always ready to accompany GENTIS to promptly update the latest improvements and advances, bringing the best experiences to customers.”
Mr. Đặng Minh Tuấn, representing GICG, presented the ISO/IEC 27001:2022 certification to Mr. Đỗ Mạnh Hà, General Director of GENTIS
GENTIS and the mission to enhance healthcare services in genetic testing
In September 2023, GENTIS received the ISO 15189:2012 certification for its NIPT, PGT-A, and Thalassemia newborn screening services. To further affirm its efforts in building, developing, and ensuring quality for customers, GENTIS immediately improved and updated the quality in its laboratories to meet the stringent criteria of the ISO 15189:2022 version as soon as it was issued.
At the same time, in the context of personal information and medical data becoming increasingly important and sensitive, achieving ISO/IEC 27001:2022 certification also demonstrates GENTIS's strong commitment to protecting customer data. GENTIS's information security management processes and systems have been rigorously established and controlled to ensure the confidentiality, integrity, and availability of data.
Mr. Đỗ Mạnh Hà, General Director of GENTIS, proudly shared GENTIS's efforts on the journey to achieve ISO 15189:2022 and ISO/IEC 27001:2022 certifications
Achieving the two ISO 15189:2022 and ISO/IEC 27001:2022 certifications not only affirms GENTIS's quality but also reflects the company's continuous efforts to improve and enhance its services. Mr. Đỗ Mạnh Hà, General Director of GENTIS, shared: "We are extremely proud to be the pioneering genetic testing laboratory in Vietnam to achieve the ISO 15189:2022 and ISO/IEC 27001:2022 certifications. This is not only a significant achievement for GENTIS but also an important step forward in improving healthcare services in Vietnam. We are committed to continuously maintaining and enhancing quality standards to provide our customers with the best services."
These two important ISO certifications not only demonstrate GENTIS's continuous efforts in maintaining and improving service quality but also affirm the company's pioneering position in the field of genetic testing in Vietnam. GENTIS is committed to continuing to innovate and apply the latest international standards to bring the best services to customers.
