ISO 15189

ISO 15189 Standards

ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.

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.

ISO 15189 Standards: For Medical and Clinical Laboratories

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The Value of ISO 15189 Compliance

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 Role of ISO 15189

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:

  • Establish systems that are as failure resistant as possible.

  • Reduce errors.

  • Catch mistakes before they turn into bigger issues.

  • Improve right-first-time metrics.

  • Identify continual improvement opportunities.

  • Enhance their problem-solving capabilities.

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MasterControl is the global leader in quality process and task automation. Our integrated solutions are designed to ease the burdens of ISO 15189 compliance. The software streamlines document control, training and any other process that affects safety and risk.

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