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ISO 15189:2003 Medical laboratories Particular requirements for quality and competence
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ISO 15189 is an international standard for medical laboratories which specifies the quality management system requirements particular to medical laboratories.
Medical laboratories seeking accreditation and certification are required to implement ISO 15189.
To fill out ISO 15189, laboratories must follow the guidelines provided in the standard and ensure compliance with the quality management system requirements.
The purpose of ISO 15189 is to ensure the quality, competence, and reliability of medical laboratory services.
Information such as quality management system documentation, proficiency testing results, corrective actions taken, internal audits, and management reviews must be reported on ISO 15189.
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