Questions and Answers on Deliverable 12: Comments on the Inter-EURL guidance for the validation of Whole Genome Sequencing for accreditation

This document compiles questions raised by EU Member States regarding the Inter-EURL Guidance for the Validation of Whole Genome Sequencing (WGS) for Accreditation (link) and provides official responses from the Inter-EURLs Working Group on NGS. It aims to support National Reference Laboratories and Official Laboratories in implementing and validating WGS workflows in line with Regulation (EU) 2025/179.

The Q&A clarifies key aspects related to accreditation, validation requirements, bioinformatics pipelines, quality criteria, and the scope of WGS applications.

The document serves as a practical technical reference to support laboratories in the validation and accreditation of WGS workflows, providing technical recommendations and best practices for their implementation.