Health 2030 Genome Center Quality Management System (QMS): An ISO 15189-Guided Legacy Resource for Genomic Laboratories

Health 2030 Genome Center / ETH PHRT Clinical Genomics Analysis Platform The Health 2030 Genome Center (GC) was established in 2017 as an inter-institutional initiative under the Swiss Federal Institute of Technology (ETH) Focus Area Personalized Health and Related Technologies (PHRT), bringing together academic institutions, university hospitals, and technology partners to advance genomic medicine. The mission of the GC was to build an open platform providing ISO 15189 (medical laboratory) accredited sequencing, data analysis and governance capabilities to support emerging needs for high-throughput human health-related genomics. In 2021, the GC obtained ISO 15189 accreditation for broad applications of human whole-genome sequencing (WGS), whole-exome sequencing (WES) and RNA-sequencing - one of the broadest accreditation scopes achieved for human genomics at this scale. Human genomics is shifting worldwide from a primarily research-oriented applications toward clinical implementation at scale, converging on the need for coordinated, clinical-grade sequencing capacity. The GC anticipated this need early on by developing and maintaining a comprehensive Quality Management System (QMS) to ensure high-quality, reproducible, and traceable processes for generation, analysis and governance of large-scale genomic data. Over the years, the QMS matured through continuous improvement of operations, practical experience gained in the rapidly evolving field of human genomics, and close collaborations with clinical and research partners. Following a 2026 governance decision to integrate the GC into a hospital department, its original organization as a stand-alone, clinical-grade genomics platform ends. Rather than let this experience go unused, we are publishing the Health 2030 Genome Center QMS as an open, freely reusable legacy resource for the genomics and clinical laboratory community worldwide. By making this QMS openly available, the former Health 2030 Genome Center aims to reduce duplication of effort, accelerate the adoption of robust quality practices across human genomics, multi-omics, and precision medicine, and contribute a concrete, field-tested building block to the global movement toward clinical-grade, interoperable genomic data generation and governance. This publication is not intended as a universal template for quality management, nor as a complete or directly transferable ISO 15189 implementation package. It offers an exemplary structure, together with templates, procedures, and supporting materials, that laboratories and infrastructures anywhere may utilize, adapt, or reference when developing or strengthening their own quality systems. The documents reflect the organizational context and regulatory landscape in which they were originally developed; users are encouraged to critically assess and adapt the material to their own local requirements, applicable regulations, and accreditation frameworks. Laboratories requesting ISO 15189 accreditation remain responsible for ensuring alignment with the applicable version of the standard and with relevant regulatory requirements. This resource is released under a Creative Commons Attribution 4.0 International License (CC BY 4.0). Users are free to share, copy, and redistribute the material in any medium or format, and to adapt, remix, transform, and build upon it for any purpose, including commercial use, provided that appropriate credit is given to the Health 2030 Genome Center / ETH PHRT Clinical Genomics Analysis Platform, a link to the license is provided, and any changes made are clearly indicated. License: Creative Commons Attribution 4.0 International (CC BY 4.0) Keywords: quality management system; ISO 15189:2022; medical laboratory accreditation; clinical genomics; human genomics; precision medicine; genomic medicine; next-generation sequencing; whole-genome sequencing; whole-exome sequencing; RNA sequencing; bioinformatics; quality assurance; standard operating procedures; laboratory infrastructure; open access; open science; FAIR data