Measurement uncertainty in testing of biologicals in national control laboratories for ISO/IEC 17025: practical approaches

The challenges in estimating measurement uncertainty in the complex matrix of biological systems, while doing compliance testing by National Control Laboratories and its importance in meeting ISO/IEC 17025 requirements are emphasised. Two primary approaches for MU, the bottom-up and top-down approac...

Full description

Saved in:
Bibliographic Details
Published in:Accreditation and quality assurance 2024-06, Vol.29 (3), p.253-261
Main Authors: Tewari, Shalini, Trivedi, Niharika, Goel, Sanchi, Shrivastava, Rashmi, Gopinath, Sudha V., Khurana, Ayushi, Anvikar, Anupkumar R.
Format: Article
Language:English
Subjects:
Accreditation
Analytical Chemistry
Biochemistry
Biological products
Chemistry
Chemistry and Materials Science
Commercial Law
Compliance
Control charts
Control data (computers)
Ecotoxicology
Food Science
Marketing
Practitioner's Report
Quality control
Quality standards
Reagents
Testing laboratories
Uncertainty
Vaccines
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The challenges in estimating measurement uncertainty in the complex matrix of biological systems, while doing compliance testing by National Control Laboratories and its importance in meeting ISO/IEC 17025 requirements are emphasised. Two primary approaches for MU, the bottom-up and top-down approaches, are discussed. Highlighting the significance of accurate estimations in NCLs, it advocates the use of a top-down approach by leveraging available quality control data and control charts for precision and bias assessment and balancing regulatory compliance to ensure the product quality and its timely release into the market, while complying with accreditation standards.
ISSN:0949-1775
1432-0517
DOI:10.1007/s00769-024-01589-8