ISO In a box: Developing a framework to enable the development of end-to-end genomics-based ISO 15189 and ISO 17025 accredited services, anywhere in the world

A researcher at Wellcome Sanger builds an innovative new pipeline for TB. A public health professional in Malawi wants to implement a new genomics-based tool for HIV. Africa CDC wants to build a continent-wide system for outbreak support. In all three cases, the limiting factor isn’t the vision of senior leaders, the desire of healthcare professionals or the innovation of researchers. It is the ability to turn a combination of laboratory approaches and bioinformatics software into a service that can be accredited to the relevant global ISO accreditation standard. The core concept of this proposal is that we can build upon our consortiums pre-existing experience of ISO accreditation of bioinformatics to modularise the key requirements for ISO 15189 accreditation of bioinformatics processes and develop a playbook (including training) for the accreditation of bioinformatics services. Our key goal is, therefore simple, working with a broad consortium we want to: - Lower the barrier of entry to labs, particularly in LMICs, who want to accredit bioinformatics/genomics processes, - Enable researchers to develop software that is 'accreditable by design' In so doing, we will improve the translation of bioinformatics research into practice, improve healthcare globally, and enhance global equity and access to genomics technologies.