ISO 15189
ISO 15189:2012 is an International Standard for medical laboratories. Its criteria help labs develop quality management systems and appraise their competence. ISO 15189 Accreditation provides recognition to the medical laboratories' competence, including both the management system and technical practices of the laboratory. ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel’s qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors.
ISO 15189:2012 is a globally used standard for quality and competence of medical laboratories. This international standard is based on ISO/IEC 17025 (Requirement for competence of testing and calibration laboratory) and ISO 9001 (Requirement for Quality Management System).
GBQC offer ISO 15189:2012 Accreditation consultancy for system implementation, documentation, internal auditing, auditors training, etc.