Labnormen

Labnormen, or laboratory norms, refer to the collection of standards, guidelines, and normative documents that govern laboratory practice across science, industry, and healthcare. They aim to ensure safety, reliability, and comparability of measurements and results, and to support regulatory compliance and quality management.

Key areas covered include safety norms (handling of chemicals, waste management, biosafety levels), quality management (documented procedures, calibration, traceability, validation, and continuous improvement), and metrology (use of validated methods, measurement uncertainty, method accuracy, instrument calibration). Norms are mainly developed by international standard bodies such as ISO (International Organization for Standardization) and IEC; in Europe by EN standards; in Germany by DIN, with accreditation bodies such as DAkkS assessing conformity to ISO/IEC 17025 and related standards.

Prominent norms include ISO/IEC 17025 for the competence of testing and calibration laboratories, ISO 15189 for medical laboratories, and frameworks such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) where applicable. Laboratories often implement standard operating procedures (SOPs) aligned with these norms and maintain records for traceability to SI units, calibration certificates, reagent provenance, and proficiency testing results.

Impact: Labnormen support data integrity, inter-laboratory comparability, and regulatory compliance, enabling results to be trusted across borders. They evolve with scientific advances and new methods, requiring ongoing training and periodic audits to maintain accreditation.