The Clinical Sterilisation Service Department (CSSD) at King’s College Hospital has received the coveted ISO 13485:2016 Medical Device Certification from the British Standard Institute (BSI) for its quality management system within the department.
The Certification specifically covers the management system for the provision of disinfection and sterilisation services for re-usable invasive medical devices. It is an International standard which is recognised globally. The King’s College Hospital ISO success comes in the wake of accreditation by the Joint Commission International (JCI) earlier this year.
ISO 13485:2016 assesses a range of criteria including, customer focus, responsibility & authority, competence & training, work environment, environmental controls, traceability to patient, internal audits, control of documentation, control of corrective and preventative actions and validation of processes.
Geraldine McNulty, Decontamination Lead/Medical Device and ISO 13485 hospital representative states, “achieving this Certification is a significant milestone for our CSSD Department at Kings College, this ISO Certification demonstrates King’s College Hospital’s commitment to provide the best, safest, decontamination standards which directly impact on clinical outcomes within the hospital setting and beyond as it further strives to outsource its CSSD Service to Clinics & Day-care Centres in and around Dubai.”
