Why ISO accreditation matters
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 15189 for medical laboratories
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.