Calibration is the comparison of an equipment indication or output against a suitable reference standard under defined conditions. The result helps users understand measurement accuracy and whether the equipment meets selected acceptance criteria.
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Calibration supports patient safety, clinical confidence, maintenance planning, audit readiness and reliable equipment history by identifying drift in measured or delivered values.
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Onsite calibration may be possible when the equipment, method, environment, reference standards and approved scope allow it. Some equipment is better handled in a laboratory.
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Calibration frequency depends on manufacturer recommendations, equipment risk, usage, operating environment, past results, repair history and the hospital's policy.
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A competent calibration laboratory or authorised service provider can issue a calibration certificate. NABL-accredited certificates apply only when the activity is within the laboratory's approved scope.
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Measurement uncertainty expresses the doubt associated with a measurement result. It helps users understand confidence in a result and should be considered with acceptance criteria.
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Calibration requirements depend on equipment use, risk, manufacturer instructions, hospital policy, accreditation expectations and regulatory requirements. Hospitals usually maintain calibration records for applicable biomedical equipment.
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Hospitals preparing for NABH assessment typically maintain calibration records, equipment identification, due-date tracking and preventive maintenance evidence for applicable biomedical equipment.
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A certificate reports results for the date of calibration. The next due date is normally decided by the customer policy, manufacturer recommendation, risk level and usage history.
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Expired calibration can create audit findings, weaken equipment traceability and affect confidence in records. Hospitals should track due dates and take corrective action when records expire.
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Calibration drift is the gradual change in equipment indication or output over time. It may be caused by age, usage, environment, wear, transport, repair or component changes.
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As-found data records the equipment condition before adjustment or corrective action. It helps users understand whether equipment was within limits when received for calibration.
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As-left data records the final condition after adjustment, repair or calibration activity. It helps show the state of the equipment when the work is completed.
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A calibration interval is the planned time between calibration events. It should be based on risk, use, history, manufacturer guidance and the organisation's quality policy.
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A decision rule explains how measurement uncertainty is considered when declaring pass or fail against acceptance criteria.
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No. Calibration measures and reports performance. Repair corrects a fault. Equipment may need repair if calibration results show unacceptable performance.
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No. Adjustment changes equipment output or indication. Calibration compares equipment with a reference standard and documents results.
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Verification checks whether equipment meets specified requirements. Calibration may support verification, but verification can include broader checks against acceptance criteria.
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Traceability links a measurement result to recognised references through an unbroken documented chain of calibrations and standards.
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Tolerance is the allowed difference between the measured value and the expected value. It should be defined before pass or fail decisions are made.
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