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FV Hospital Laboratory & Blood Bank Achieves ISO 15189:2022 Accreditation, Expanding Scope to 44 Accredited Tests

FV Hospital’s Laboratory & Blood Bank Department has successfully completed its international re-assessment and achieved full compliance with ISO 15189:2022, the latest and most rigorous global quality standard for medical laboratories. This milestone confirms the laboratory’s excellence in quality management, technical competence, and patient safety, while expanding the total number of ISO-accredited tests to 44.

Strict sample control under ISO 15189:2022 standards

FV had previously been accredited to ISO 15189:2012; however, this assessment marked an important step forward with the transition to ISO 15189:2022, together with the Additional Requirements for the Assessment of Medical Laboratories (ARM 03:2024). In addition, the assessment team reviewed several other aspects in line with national quality criteria. ISO 15189:2022 is the latest standard specifically designed for medical laboratories, with more stringent requirements for risk management and a strong focus on patient safety. This transition further reinforces FV Hospital’s commitment to delivering reliable laboratory services with high clinical value.

As part of this assessment cycle, the Laboratory & Blood Bank Department successfully added three new tests to its accredited scope, bringing the total to 34 biochemistry, five (5) immunology and five (5) haematology tests. This achievement reflects the department’s robust analytical performance, strong validation processes, and consistent adherence to international best practices.

Behind this success lies the exceptional dedication of our Laboratory & Blood Bank team, who work tirelessly—often late into the evening—to ensure every process meets the highest international standards. The expert assessors from the Bureau of Accreditation (BoA) commended the team for their high level of compliance, professional competence, and culture of continuous improvement.

The Laboratory & Blood Bank team at FV Hospital proudly maintains international standards of technical competence and service quality

Mr. Friend Maviza, Head of the Laboratory & Blood Bank Department, shared: “This means that our laboratory the highest international standards for medical testing. For patients, this provides reassurance that every test is performed following carefully controlled processes, with strong checks in place to ensure accuracy, safety, and reliability. This recognition reflects the commitment of our laboratory team to delivering results that doctors can trust and that patients can feel confident about. At FV Hospital, we continuously improve our laboratory services to support safe diagnoses, effective treatment, and the best possible care for every patient.”

He further acknowledged the collective efforts of the FV Hospital multidisciplinary teams, particularly the nursing staff, ICT, and Biomedical team – for working closely with the laboratory in upholding the hospital’s mission of delivering world-class medical services, ensuring confidence and peace of mind for both patients and healthcare professionals.

Mr. Friend Maviza (Head of Department) and a colleague monitor operational procedures on advanced laboratory equipment

FV Hospital’s Laboratory & Blood Bank Department continues to hold a unique position in Vietnam’s healthcare landscape as the first medical laboratory operating within a JCI-accredited hospital while simultaneously maintaining ISO 15189 accreditation and Westgard Sigma VP certification. This combination underscores FV’s leadership in laboratory quality, clinical governance, and performance excellence.

Following this successful re-assessment, the department is actively building on expert feedback to optimise workflows, enhance analytical capability, and further strengthen clinical support, ensuring that laboratory services continue to contribute directly to better diagnostic accuracy, informed clinical decisions, and improved patient outcomes.

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