The advISO project has developed a modular framework to guide laboratories in achieving international bioinformatics accreditations. It provides practical tools and training resources to support medical laboratories, to achieve ISO 15189 and ISO 17025 accreditation.

The freely available and accessible modular framework resources can be used independently or as part of a lab’s ISO accreditation journey.

The advISO Project, is led by Cardiff University, with Public Health Wales, Wellcome Sanger Institute, and the South African National Bioinformatics Institute as key partners. advISO is funded by the Wellcome Trust and launched in August 2024.

Medical laboratories generate the data that underpin patient care, outbreak response, and population health surveillance.

The accuracy of this data is essential: errors can propagate across healthcare and public health systems, with consequences for individual patients and wider populations.

Laboratory quality is protected through accreditation, which assesses competence against international standards. ISO 15189 for medical labs and ISO 17025 for testing and calibration labs form the core global frameworks. Created in the 1990s, both standards focus mainly on traditional wet‑lab workflows.

The advISO project aims to make ISO 15189 and ISO 17025 accreditation process for the use of bioinformatics in medical laboratories worldwide, clear and concise by constructing a modular framework.

Bioinformatics is a relatively new modality in medical laboratories. It is a digital, rather than a laboratory discipline. This creates tangible issues when bioinformatics must be integrated into ISO 15189 or 17025 processes that are designed from a laboratory perspective.

We have identified a set of significant challenges that are holding back the development of bioinformatics approaches within accredited labs, including:

• differences between bioinformatics language and processes to those used in the wet-lab

• different competency and training requirements for bioinformatics staff at all career stages

• different requirements for validation and verification, particularly with respect to dataset building

• different considerations in terms of fixing issues and updating software and databases

• the pace of innovation and the impact this has on the evolution and iteration of processes used to deliver services

We have defined a set of modular components. These can be customised and built upon by the wider community to simplify the accreditation process. We provide these modular components with implementation roadmaps that can be modified and scaled to any environment based on the point of entry and the needs of the user.

All outputs will be made freely available. These are shared through a variety of platforms within the user community. The project is working with collaborators in lower, middle income countries to lower the barriers to accreditation of medical laboratories.

The gold standard for quality assurance for testing laboratories are ISO 15189 and ISO 17025 accreditation. ISO accreditations form the basis for legal and medical regulations to improve the quality of a country’s healthcare.

The International Organisation for Standardisation is an international body that ensures the products and services you use daily are safe, reliable, and of high quality.

ISO accreditations provide:

• assurance to users of services that the services provided are of good quality

• external validation/marks of achievement to providers, evidencing their competence

• a mechanism for harmonisation between laboratories

• a common standard benchmark that everyone, globally, can work towards, enabling global equity

• the basis for legal and medical regulations to improve the quality of healthcare globally

• a core of competent laboratories with systems in place that can lead a response to emerging threats, such as pandemics

ISO accreditations offer a regulated way to check that laboratory processes meet strict criteria. By following ISO standards, labs show users that the services meet quality and safety standards. Accreditation creates a shared framework that helps labs globally work in a consistent way.

ISO 15189 has guided medical laboratory wet-lab process accreditation for more than twenty years. Its focus on standardised methods, calibrated equipment, and clear documentation has helped labs worldwide deliver reliable, high‑quality tests.

Genomics has changed the landscape. Modern diagnostics increasingly depend on genomic data, and bioinformatics now determines much of a test’s accuracy. Problems with genomic samples often appear only after sequencing. Once sequencing quality is assured, results depend on the bioinformatics pipeline. Yet current accreditation standards give little guidance for these digital processes.

This gap is especially challenging for laboratories in low‑ and middle‑income countries. Here, bioinformatics infrastructure and training may be limited. As sequencing becomes more accessible, the lack of accredited, scalable bioinformatics solutions risks widening global inequality.

There is also a divide between research and clinical practice. Many bioinformatics tools are not designed with accreditation in mind. This makes them hard to adopt in regulated settings. To fix this, developers need to build “accreditation by design” into tools from the start. It needs to cover validation, documentation, and quality controls.

Key hurdles include mismatched terminology between wet‑lab and digital workflows. Other challenges includes, different training needs for bioinformatics staff, and unique demands for software validation and maintenance. Rapid innovation makes it even harder to set consistent standards.

Without addressing these barriers, the integration of genomics into clinical and public health labs will lag. As a result, LMICs may be left behind. Solving these challenges through coordinated, global effort would unlock the full power of bioinformatics, strengthen diagnostics, improve public health, and support fair access to genomic technologies worldwide.

Medical laboratories handle high volumes of samples under tight timelines, consistently delivering reliable results.

As essential components of the healthcare system, they support both diagnostics and public health. Accreditation ensures the quality and reproducibility of their outputs.

Medical laboratory services range from patient-focused diagnostic testing to the analysis of surveillance samples for public health. The data produced flows through healthcare systems to inform patient care, hospital outbreak responses, and broader decisions at regional or national levels, including policy-making and pandemic response.

The reliability of medical laboratory outputs is critical. Ensuring laboratories are competent to perform tests and produce accurate data is essential. In a globally connected healthcare landscape, results from one laboratory should be comparable to those from another. This requires systems that support collaboration across laboratories and healthcare services, both nationally and internationally. ISO accreditation enables this.

The widespread adoption of genomics and high‑throughput sequencing has transformed laboratory practice. Increasingly, reported results rely on digital processes such as bioinformatics pipelines, software tools, and data interpretation steps that occur downstream of the wet lab. Despite their critical role in determining result validity, these activities are often poorly defined within existing accreditation frameworks.

This gap presents a challenge for laboratories seeking to deliver genomics services that are both innovative and accredited. It also has significant implications for low- and middle-income countries, where the absence of clear, globally accepted best practice risks widening existing inequities.

The project has identified a set of simple, foundational measures to support the accreditation of bioinformatics activities within ISO 15189 and ISO 17025 laboratories. These measures improve quality, enable service development, and provide guidance for researchers and funders to support clinical translation.

By focusing on key pinch points, this project will work to lower barriers to genomics adoption and strengthen global preparedness for future health threats.