Table 2.

ISO standards applicable for laboratories performing NGS*

Standard	Name	Scope
ISO 15189 : 2022	Medical laboratories – requirements for quality and competence	Specifies requirements for quality and competence in medical laboratories. Includes development of quality management systems and auditing (internal and external) to assess competence
ISO 17025 : 2017	General requirements for the competence of testing and calibration laboratories	General requirements for competent and consistent operation of laboratories, ensuring they can deliver valid results. Includes risk management, how the laboratory deals with external bodies and harmonization of standards and processes
ISO 23418 : 2022	Microbiology of the food chain — whole-genome sequencing for typing and genomic characterization of bacteria — general requirements and guidance	Specifies minimum requirements for generation and analysis of whole-genome sequencing data of bacteria from the food chain

*ISO 20397-1 : 2021 and ISO 20397-2 : 2021, Massively Parallel Sequencing (MPS) parts 1 and 2, respectively, may also be of interest. These ISO standards specify guidelines for sequence library generation, quality assessments, post-raw data generation, sequencing alignments and variant calling using MPS data. However, these documents focus on requirements for human sequences rather than pathogen genomics and do not cover assembly of genomes.