ISO 9001 / ISO 13485 clause 7.6 | ISO 22716 Cosmetics GMP clause 5.4 – Control of monitoring and measuring equipment | Calibration

Historically, all equipment/measuring devices that are calibrateable in organizations are calibrated. Rather than calibrating every measuring device, adopt a risk based approach. Use this method also to indicate where equipment qualification is required (ie IQ/OQ/PQ). Eg, equipment that is classified as risk levels with severities 3 (serious),4 (critical),5 (catastrophic) will require qualification and calibration. Equipment that are low risk – severities 1(negligible) and 2(minor) will not require any qualification/calibration.

 

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Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.