White Paper: Think About It – S01

In-House Vs Accredited Calibration

Healthcare and laboratory facilities rely on calibration to ensure the accuracy, safety, and reliability of medical equipment. While in-house and non-accredited calibration approaches support daily operational efficiency and cost control, they often lack the independence, verified technical competence, and documented measurement uncertainty required to withstand audit and regulatory scrutiny. This limitation can lead to compliance risks, audit findings, and reduced stakeholder confidence.

This paper examines the practical and regulatory differences between in-house, non-accredited, and ISO/IEC 17025-accredited calibration services. It highlights how traceability alone is insufficient without demonstrated competence, impartiality, and internationally recognized validation. Through a risk-based, layered calibration strategy, organizations can assign routine checks internally while reserving accredited calibration for high-risk and compliance-critical equipment.

By aligning calibration practices with clinical risk and accreditation requirements, healthcare institutions can control costs while preserving independent assurance, regulatory confidence, and patient safety.