ISO 15189 - MODULE 1 – RESOURCE AND INFRASTRUCTURE REQUIREMENTS FOR COMPETENCE IN A MEDICAL/CLINICAL LABORATORY

 This module covers clauses 5.1 to 5.3 of the standard.

Medical laboratory infrastructure and resources are within eight broad classes covering competent personal, quality material, the testing environment, the testing equipment and all types of supplies used to support competent testing. This is in addition to requirements for metrological traceability of clinical measurements and the measurement equipment that is used to produce results and control the testing environment.

Accreditation of medical/clinical laboratories by ILAC-recognised accreditation bodies includes examination of these resources. 

Associated policies, procedures and records are discussed in this Module with examples. This session is 90 minutes in duration and is delivered in two Parts:

Part 1: Resource procurement, management and continual improvement

Part 2: Policies processes and records requirements for conformity assessment bodies (in this case medical testing laboratories)