All UKAS certificates of accreditation for ISO 15189 Medical Laboratories are being updated following the November 2021 issue of a revised Joint IAF-ILAC-ISO Communiqué on the Management system requirements of ISO 15189, as the current certificates refer to the January 2015 issue of the communiqué.
Requirements of ISO 15189
Statements for use on test, study, calibration, and check reports/certificates have also been revised
The communiqué states: "A medical laboratory’s fulfillment of the requirements of ISO 15189 means the laboratory meets both the technical competence requirements and the management system requirements necessary for it to consistently deliver technically valid test results."
It continues, "The management system requirements in ISO 15189 are written in language relevant to a medical laboratory’s operations. Medical laboratories that implement ISO 15189 operate generally in accordance with the principles of ISO 9001."
Certificate updates scheduled for 21 January 2022
The certificate updates are scheduled for 21 January 2022. Links to electronic certificates will not be affected. UKAS publication TPS 53 Management system requirements of laboratories (ISO/IEC 17025 and ISO 15189) and inspection bodies (ISO/IEC 17020) – Statements for use on test, examination, calibration, and inspection reports/certificates have also been revised to reflect the update to the communiqué.
