NABL 15189 – Medical Laboratories

ISO 15189 is the internationally recognized standard that specifies the requirements for quality and competence in medical laboratories. NABL accreditation to ISO 15189 demonstrates that a medical laboratory is competent to carry out tests and examinations, ensuring accurate, reliable, and timely patient results.

This standard applies to medical laboratories involved in patient care, including pathology, biochemistry, hematology, microbiology, immunology, and molecular diagnostics, regardless of size or ownership.

Commitment to Medical Laboratory Quality and Patient Safety

NABL ISO 15189 accreditation reflects a laboratory’s commitment to patient safety, clinical accuracy, and ethical laboratory practices. It ensures that test results are produced by qualified personnel using validated methods, appropriate equipment, and controlled processes aligned with clinical needs.

The standard integrates quality management and technical competence, emphasizing risk-based thinking, continual improvement, and reliable clinical decision support.

Why NABL ISO 15189 Matters

NABL ISO 15189 accreditation confirms that medical laboratories:

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    Ensure competence of laboratory personnel and clinical processes
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    Deliver accurate, reliable, and clinically relevant test results
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    Maintain traceability, calibration, and quality control of equipment
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    Operate with impartiality, confidentiality, and ethical responsibility
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    Comply with regulatory, statutory, and healthcare requirements
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    Implement effective risk management and patient-focused processes

Benefits for Patients, Clinicians, and Healthcare Partners

By working with a NABL ISO 15189 accredited medical laboratory, stakeholders gain:

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    Patient Safety – Accurate and reliable diagnostic results supporting correct clinical decisions
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    Clinical Confidence – Trustworthy laboratory data for diagnosis and treatment
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    Regulatory Assurance – Compliance with healthcare laws and accreditation requirements
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    Risk Reduction – Reduced errors, rework, and diagnostic discrepancies
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    Professional Credibility – Demonstrated commitment to quality, ethics, and excellence in healthcare

Enhancing credibility and trust with internationally recognized certifications

Strengthen credibility, meet international compliance standards, and build trust with customers and stakeholders through globally recognized ISO and compliance certifications.

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