advISO project background
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.
The challenges
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
Our approach
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.
