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International standards in laboratory medicine
1Department Clinical Chemistry, Karolinska Hospital, S-171 76, Stockholm, Sweden. anders.kallner@lab.ks.se
Summary
International standards, including ISO and CEN, are crucial for medical laboratory quality systems. Standards like ISO 17511 improve traceability and measurement uncertainty, ensuring calibrator consistency.
Area of Science:
- Clinical Laboratory Science
- Metrology in Laboratory Medicine
- Quality Management Systems
Background:
- International standards are essential for establishing robust quality systems in medical laboratories.
- Organizations like ISO (International Organization for Standardization) and CEN (European Committee for Standardization) develop numerous standards for laboratory medicine.
- Standard development typically involves industry input and iterative review by users, though individual influence is limited.
Purpose of the Study:
- To highlight the critical role of international standards in enhancing quality systems within medical laboratories.
- To discuss the impact of specific standards on methodological practices, reagent performance, and metrological concepts.
- To address challenges and propose solutions for the traceability of biological calibrators.
Main Methods:
- Review of existing international standards (ISO, CEN) relevant to medical laboratory quality.
- Analysis of the influence of standards on laboratory practices, using examples like ISO 15196 and ISO 17511.
- Discussion of metrological concepts such as traceability, uncertainty, and trueness in the context of laboratory medicine.
Main Results:
- Standards significantly influence quality systems, methodological practices, and the performance of reagents and kits.
- ISO 17511 demonstrates the importance of traceability, uncertainty, and trueness for calibrators.
- Biological calibrators present unique traceability challenges, often not being directly traceable to the International System of Units (SI).
Conclusions:
- International standards are vital for ensuring quality and consistency in medical laboratory operations.
- Defining and referring to reference procedures is more advantageous for traceability than relying solely on reference materials.
- Improved traceability through reference procedures reduces uncertainty and guarantees metrological consistency of calibrators across different batches.