ISO 15189:2022 – is an International standard that addresses Quality and Competence in Medical Laboratories. ISO 15189 can be applied by any Medical laboratory in order to develop an efficient Quality Management System (QMS) and to assess its own competence.
ISO 15189:2022 is the latest standard and it was developed with the participation of the medical, scientific, and clinical community, and it contains requirements for diagnostic labs to demonstrate competence to deliver timely, accurate, and reliable results.
ISO 15189 health accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors.
