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ROI CalculatorCalibration Management is the controlled process of ensuring that measuring and test equipment is accurate, traceable, and fit for use.
FDA 21 CFR 211.68 requires automated and measurement equipment to be routinely calibrated, inspected, and checked according to a written program. ISO 9001 and ISO 13485 require monitoring and measuring equipment to be calibrated against traceable standards, with records maintained.
Why it matters: because uncalibrated equipment often leads to invalid test results, batch rejections, audit findings, and potential recalls. This will eventually increase Cost of Quality.
