Quality Certificate
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Quality Certifications
ISO 15189:2022 Accreditation
ISO 15189:2022 is an international standard for medical laboratories, issued by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). It was developed to update and consolidate the previous requirements of ISO 15189:2012 and ISO 22870:2016. This edition is structured in line with the modern management framework of ISO/IEC 17025:2017, with a dual focus on technical competence, process effectiveness, and the quality management system within medical laboratories.
At OneLab, the core principles of ISO 15189:2022 are applied as guiding standards throughout professional practice and laboratory operations. Standardizing processes in accordance with international standards enables OneLab to maintain accuracy and consistency of results, enhance transparency in quality control, and deliver a clear, reliable, and consistent service experience for customers and healthcare partners.
Introduction to BoA
BoA (the Bureau of Accreditation) is Vietnam’s sole national accreditation body, operating under the Ministry of Science and Technology. Its mandate is to assess and accredit the competence of organizations in accordance with national and international standards.
BoA operates in line with international accreditation practices and is a member of global mutual recognition arrangements, ensuring that accreditations recognized by BoA are valid and widely accepted both domestically and internationally.
In the field of medical laboratories, BoA accreditation to ISO 15189:2022 is not merely a confirmation of a quality management system, but a comprehensive assessment of actual professional competence, including:
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Technical testing competence evaluated and recognized in accordance with international standards
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Reliability and traceability of results, ensuring transparency and consistency
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Risk management and quality control throughout the entire testing lifecycle (pre-analytical – analytical – post-analytical)
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Compliance with clinical requirements and assurance of patient safety
Therefore, ISO 15189:2022 accreditation recognized by BoA is regarded as a high-level and stringent form of accreditation, reflecting the true capabilities of a medical laboratory and going beyond certifications that focus solely on procedural compliance.
Clinical Chemistry
Quantitative glucose measuremen
AST activity measurement
ALT activity measurement
Quantitative urea measurement
Quantitative triglycerides measurement
Quantitative cholesterol measurement
Quantitative FT3 measurement
Quantitative FT4 measurement
Quantitative TSH measurement
Hematology
White blood cell count
Red blood cell count
Hemoglobin concentration measurement
Platelet count
Mean corpuscular volume (MCV)
Prothrombin time (PT)
Activated partial thromboplastin time (aPTT)
