Quality Certificate
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Quality Certifications
ISO 15189:2022 Accreditation
ISO 15189:2022 is the international standard that specifies the requirements for the quality and competence of medical laboratories, published by the International Organization for Standardization (ISO). The 2022 edition replaces ISO 15189:2012 and ISO 22870:2016 and is aligned with the management system structure of ISO/IEC 17025:2017 to enhance consistency in quality management and laboratory competence assessment. The standard emphasizes technical competence, risk management, process effectiveness, patient safety, and continual improvement throughout laboratory operations.
At OneLab, the requirements of ISO 15189:2022 are implemented across all professional and quality management activities. By standardizing laboratory processes in accordance with internationally recognized standards, OneLab ensures technical competence while maintaining the accuracy, reliability, and traceability of test results. This approach also strengthens quality control, supports continual improvement, and delivers consistent, high-quality laboratory services to patients, healthcare providers, and medical partners.
About BoA
BoA (Bureau of Accreditation) is Vietnam’s sole national accreditation body and a public non-business unit operating under the National Standards Metrology and Quality Commission (STAMEQ). BoA is responsible for carrying out accreditation activities in support of the State’s management of standards, metrology, quality, and conformity assessment. As the national accreditation body, BoA evaluates and accredits the competence of conformity assessment bodies in accordance with national and international standards.
BoA operates in compliance with ISO/IEC 17011 and the international accreditation frameworks established by ILAC (International Laboratory Accreditation Cooperation), IAF (International Accreditation Forum), and APAC (Asia Pacific Accreditation Cooperation). BoA is also a signatory to international Mutual Recognition Arrangements (MRAs), enabling accreditations granted by BoA to be widely recognized throughout Vietnam and in many countries worldwide.
In the field of medical laboratories, accreditation to ISO 15189:2022 by BoA not only demonstrates that a laboratory’s quality management system complies with internationally recognized standards but also verifies its technical competence, including:
- Technical competence in medical laboratory testing assessed against the requirements of ISO 15189:2022.
- Reliability, accuracy, and traceability of laboratory test results.
- Quality management and risk control throughout the entire testing process (pre-examination, examination, and post-examination).
- Compliance with clinical requirements, contributing to patient safety and the continuous improvement of laboratory service quality.
- Clinical Chemistry
- Hematology
