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HANOI FRENCH HOSPITAL’S LABORATORY DEPARTMENT ACHIEVES ISO 15189:2022 CERTIFICATION IN BIOCHEMISTRY-HEMATOLOGY-MICROBIOLOGY ON FIRST ASSESSMENT
On June 24, 2025, the Laboratory Department of ƽ (ƽ) officially received the ISO 15189:2022 certificate issued by the Accreditation Office for Standards Conformity Assessment Capacity (AOSC) during its very first assessment. The certification covers tests in three key areas: Hematology, Biochemistry, and Microbiology.
ISO 15189 is an international standard specifically designed for medical laboratories, setting stringent requirements for quality management systems, technical competence, and reliability of test results. The 2022 version is the latest edition, emphasizing requirements to ensure high accuracy and reliability of test outcomes and risk control in laboratory operations.
The certification ceremony was held in a formal atmosphere with the participation of ƽ’s leadership team, including General Director and Chief Medical Officer Dr. Erwan Debuc, Quality Management Head Ms. Nguyen Thi Thu Ha, and Laboratory Department Head Dr. Pham Hai Yen, along with doctors, technicians from the Laboratory Department, and related departments. Representatives from AOSC included evaluation expert Associate Professor Dr. Pham Thien Ngoc – Vice President of the Vietnam Society of Biochemistry and Molecular Biology, and Mr. Nguyen Tien Duc – Head of Customer Service at AOSC.
AOSC is an independent organization authorized by the government to assess and accredit laboratories according to international standards. The ISO 15189 certificate issued by AOSC is internationally recognized through mutual recognition agreements (APAC/ILAC-MRA), ensuring the credibility and global acceptance of test results. Associate Professor Pham Thien Ngoc announced the decision and awarded the accreditation certificate to ƽ. He noted, “The Laboratory Department at ƽ, accredited for medical testing competence meeting ISO 15189:2022 standards, is a testament to comprehensive standardization - from procedures, equipment, personnel to record-keeping systems - aimed at delivering accurate, consistent, and reliable test results to support diagnosis and treatment.”
At the ceremony, Dr. Erwan Debuc, General Director and Chief Medical Officer of ƽ, stated: “ƽ is committed to maintaining and continuously improving healthcare quality according to strict international and European standards. The Laboratory Department’s achievement of ISO 15189:2022 certification not only demonstrates professional competence but also enhances our international recognition for service quality.”
As the first hospital in Vietnam to achieve ISO 9001 certification in 2007 and continuously recertified since then, ƽ maintains a rigorous quality management system while continuously investing in equipment upgrades and staff training to ensure high-quality medical services and patient safety.
Laboratory Department’s Efforts Recognized on First Assessment
The Laboratory Department at ƽ is a core unit operating 24/7 to meet the testing needs of both inpatients and outpatients. Equipped with modern testing systems, the department strictly adheres to quality control procedures and participates in reputable external quality assessment programs such as Randox (UK) and domestic calibration centers.
On its first assessment, the Laboratory Department was accredited for 19 test parameters in Biochemistry, 7 in Hematology, and 1 in Microbiology. This certification reflects the department’s professional competence and the sustained, serious efforts of all staff over a long period. Dr. Pham Hai Yen, Head of the Laboratory Department, affirmed: “The Laboratory Department will continue to improve test result quality, update new technologies, and maintain and develop the quality management system according to ISO 15189.”
Achieving ISO 15189:2022 certification across all three core laboratory fields demonstrates the hospital’s strong commitment to providing high-quality, safe, and patient-centered healthcare services. This milestone is a quality benchmark and a motivation for the hospital to continue advancing, better serving patients and gaining their trust and satisfaction at ƽ.
