The Cancer Research UK Cambridge Centre is delighted to announce that their Cancer Molecular Diagnostics Laboratory (CMDL) has been awarded ISO 15189 accreditation by the United Kingdom Accreditation Service. Obtaining ISO accreditation is a significant achievement which acknowledges that the CMDL operates within internationally recognised standards of quality and reliability for medical laboratories.
The lab has been working towards accreditation for the last three years because new EU regulatory requirements mean that clinical trial results used to inform patient management must originate from an accredited laboratory. In order to meet the ISO standards, CMDL was required to build a new Quality Management System from the ground up and establish a dedicated Quality Lead role. The involvement of a new Clinical Oversight Group of practising clinicians and consultant clinician scientists at Cambridge University Hospitals was also critical for achieving the accreditation.
As one of the few ISO 15189‑accredited laboratories outside the NHS, CMDL can now provide researchers at the University of Cambridge and local start‑ups with access to accredited diagnostics that would otherwise require outsourcing to commercial providers at significantly higher cost.
Dr Shubha Anand, CMDL Director said: “I am incredibly proud of the whole team. Their hard work, commitment, and willingness to embrace new processes have been essential to making the Quality Management System function effectively.
“This accreditation positions CMDL to support a wider range of clinical trials and diagnostic work, and it provides strong momentum to accredit additional assays that we can eventually transition into the NHS setting.”
The CMDL, which is located in the Clifford Allbutt Building on the Cambridge Biomedical Campus, is jointly funded by the Cancer Research UK Cambridge Centre and National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre.
Read full article on CRUK Cambridge Centre website
