The common components of the standard include document control, internal audits, occurrence management, and risk management. Compliance with ISO 15189 improves the overall quality of a laboratory’s services and products, which directly affects the quality of health care.
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ISO 15189 guidelines help laboratories establish an effective quality management system (QMS). Adherence to the guidelines leads to more accurate test results and fewer errors in the lab. It also boosts stakeholders’ confidence in the value of your lab testing.
The ISO 15189:2012 international standard is based on ISO/IEC 17025 and ISO 9001. It applies to all medical laboratories and is becoming the most widely accepted standard for accrediting the competence of clinical laboratories. ISO 15189 requirements are intended to help lab staff:
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