An internationally recognised quality management system (QMS) standard for the design, development, and manufacture of medical devices and IVD assays. Origin operates under an ISO 13485:2016 certified quality management system held by TOGL, applying a risk-based approach to ensure patient safety, strong user experience, and regulatory compliance for global deployment.
A legal requirement in the UK for organisations working with human tissue. The HTA regulates the removal, storage, use, and disposal of human samples to ensure consent, dignity, and traceability under the Human Tissue Act 2004. Origin operates under an HTA licence held by TOGL, permitting research, diagnostics, and product development in compliance with UK legislation.
The global standard for quality and competence in medical laboratories. Once awarded by UKAS, ISO 15189 accreditation will apply to Origin’s laboratory operations and will demonstrate technical competence, robust processes, and reliable results, ensuring precision, safety, and international recognition. The standard provides a framework for continuous improvement and trust among clinicians, regulators, and partners.