Laboratoriekvalitet

Laboratoriekvalitet refers to the degree to which laboratory results and processes meet predefined requirements for accuracy, reliability, timeliness, and fitness for purpose. It encompasses the methods used to generate data, the competence of personnel, the condition and calibration of instruments, the management of samples and data, and adherence to safety and regulatory norms. Strong laboratoriekvalitet relies on quality assurance and quality control practices that together ensure that results are credible and decisions based on them are sound.

Core elements include documented standard operating procedures, method validation, routine calibration and traceability of measurements, use of certified reference materials, participation in proficiency testing, and robust data management. A quality management system guides these activities, with evidence through internal audits, corrective actions, and performance metrics. Laboratories also address data integrity, sample chain-of-custody, and cybersecurity to protect the reliability of results.

International and national standards underpin laboratoriekvalitet. ISO/IEC 17025 specifies requirements for testing and calibration laboratories; ISO 15189 applies to medical laboratories; Good Laboratory Practice (GLP) and related guidelines govern non-clinical research. Accreditation bodies assess conformity, and many laboratories pursue ongoing improvement through risk assessment, method validation, and participation in external quality assessment schemes. Ultimately, high laboratoriekvalitet supports patient safety, environmental protection, and scientific integrity by ensuring that decisions are based on trustworthy data.