EFLM Guidance on Risk-Based Method Validation and Verification Under ISO 15189
The EFLM Working Group on Accreditation provides a risk-evaluation framework for validation and verification of laboratory examination procedures under ISO 15189:2012. The guidance demonstrates how risk assessment can be integrated at each stage of method implementation to optimize policies that satisfy both intended-use requirements and accreditation standards, offering practical recommendations for laboratories developing local or national verification documents.
The original study
Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation.
- Authors
- Roelofsen-de Beer R, Wielders J, Boursier G, Vodnik T, Vanstapel F, Huisman W, et al.
- Journal
- Clinical chemistry and laboratory medicine
- Type
- Journal Article, Validation Study
- PMID
- 31714885
Original abstract
This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.