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ISO 15189:2012 is an international standard that specifies requirements for the competence and quality of medical laboratories.
» Applicability: ISO 15189:2012 is applicable to medical laboratories of all
sizes and types,
including clinical, public health, and research laboratories.
» Purpose: The primary purpose of ISO 15189:2012 is to provide a framework for
medical
laboratories to demonstrate their competence, quality, and commitment to providing reliable and
accurate test results.
Accurate Diagnoses: ISO 15189:2012 helps ensure that medical laboratories produce reliable and accurate test results.
» Quality Management System:Continuous Improvement: The standard encourages a culture of continuous improvement, promoting regular review and optimization of laboratory procedures and practices.
» International Recognition:Global Acceptance: ISO 15189:2012 is internationally recognized and accepted as a benchmark for medical laboratory quality.
» Regulatory Compliance:Compliance with Regulations: ISO 15189:2012 helps laboratories comply with regulatory requirements in many countries.
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