Kalibrierplans

Kalibrierplans are formal documents that define the calibration activities for measurement instruments within an organization. They describe which devices require calibration, the calibration methods to be used, the interval between calibrations, acceptance criteria, and the responsibilities of personnel. The goal is to ensure measurement accuracy, traceability to recognized standards, and compliance with quality management requirements.

A Kalibrierplan typically includes: an inventory of instruments with unique identifiers; the calibration interval; reference standards and acceptance criteria; calibration procedures; documentation and record-keeping; handling of out-of-tolerance results; responsibilities; and procedures for revocation or re-calibration.

Development and maintenance: Start with inventory and risk assessment to classify instruments by criticality and usage. Determine intervals using manufacturer recommendations, historical data, and stability analyses; apply risk-based approach if possible; obtain approval; review periodically and adjust as needed. Calibrations are often tracked in a Calibration Management System or asset database; records include certificates and measurement data.

Relation to standards: Kalibrierplans align with ISO/IEC 17025, ISO 9001, GMP/GLP where applicable, and national metrology institute requirements. They support traceability, documented evidence, and auditable processes.

Benefits and implications: Implementing Kalibrierplans improves data quality, regulatory compliance, and equipment availability while reducing downtime and rework. Challenges include keeping the plan up to date, maintaining complete records, and ensuring access for authorized personnel. In practice, many organizations integrate Kalibrierplans into broader calibration management or asset-management systems.