Kalibreringsprogram

Kalibreringsprogram (calibration program) refers to a system, often software complemented by defined procedures, used to plan, execute, document, and manage the calibration of measuring instruments to maintain accuracy and traceability. It is employed in settings such as laboratories, manufacturing, healthcare, energy, and research to ensure instruments meet specified performance criteria and regulatory requirements.

A calibration program typically covers equipment calibration, reference standards, and related accessories. It includes components such as asset registers, calibration calendars or schedules, work orders, data capture during testing, certificate generation, and an audit trail. Modern programs may automate workflows from planning to approval, support uncertainty budgeting, and store historical measurement data for trend analysis.

Key features commonly found in calibration programs are traceability to national or international standards, generation of calibration certificates, management of out-of-tolerance results, deviation handling, and corrective action tracking. They often provide dashboards and reports for compliance reviews, asset performance, and maintenance planning. Data integrity and security are important considerations, with many implementations aligning to ALCOA principles and cybersecurity best practices.

Standards and compliance frameworks relevant to calibration programs include ISO/IEC 17025 for testing and calibration laboratories, ISO 10012 for measurement management, and quality system standards such as ISO 9001. In regulated industries, GMP or GxP requirements may apply, and traceability to primary standards is essential.

Implementation considerations include integration with ERP or MES systems, choosing cloud-based versus on-premises deployments, data migration, user training, and change management. A well-implemented kalibreringsprogram enhances measurement quality, regulatory compliance, operational efficiency, and instrument uptime, while reducing risk associated with inaccurate measurements.