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ISO 15189:2012 is an internationally recognized standard specifically developed for Medical Laboratories – Quality and Competence. This certification ensures that medical laboratories operate with technical competence and maintain a robust quality management system.
ISO 15189:2012 combines the principles of quality management with technical requirements necessary for delivering reliable and accurate laboratory test results. It demonstrates a laboratory’s ability to provide precise diagnostic services while ensuring patient safety and regulatory compliance.
ISO stands for the International Organization for Standardization. “15189” identifies the specific standard developed for medical laboratory quality and competence, and “2012” refers to the year of publication of the standard.
Documentation requirements vary depending on the size, scope, and complexity of the laboratory services. Our experts at ISO CERTIFICATIONS provide complete assistance in preparing quality manuals, SOPs, calibration records, internal audit reports, and other mandatory documentation required for certification.
We guide laboratories through the entire accreditation process — from gap analysis and system implementation to internal audits and final certification.