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Primary Standard: ISO 15189:2022

Medical Laboratories

Accreditation for medical and clinical laboratories, confirming both quality management and technical competence across the total testing process for accurate patient care.

Who It Applies To

Clinical, hospital, diagnostic, and pathology laboratories that examine samples from the human body and need to demonstrate quality and competence to clinicians, patients, and regulators.

Typical Scope / Activities

Hover or tap an activity to see what it covers.

Applicable Accreditation Standard

ISO 15189:2022

Medical Laboratories

Accreditation Assessment

  1. 1

    Receiving your application and defining the medical testing scope

  2. 2

    Verifying your eligibility and application details

  3. 3

    Reviewing quality and technical documents

  4. 4

    Assessing pre-examination, examination and post-examination activities

  5. 5

    Evaluating personnel and technical competence

  6. 6

    Verifying corrective actions and making the accreditation decision

  7. 7

    Conducting surveillance to maintain ongoing competence

Expected Outcomes

Recognition of quality and competence for the approved medical examinations
Greater confidence in the reliability of patient results
Stronger control over pre-examination, examination, and post-examination processes
Improved patient safety and support for clinical decision-making

Apply for Medical Laboratory Accreditation

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