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.

Optimize quality in your laboratory with ISO 15189 software.


Comprehensive Lab Quality Management


In the lab, perfection is the expectation. Accurate and traceable patient information. Safe and viable materials. Proper environmental conditions. Timely decision-making. You’re expected to master it all. And you can with MasterControl ISO 15189 software. Our quality solutions are designed to enhance the oversight of and visibility into all lab processes so you can focus on the job at hand.


Robust ISO 15189 Training Capabilities


To adhere to the ISO 15189 standard, all staff must be properly trained and qualified for their work. MasterControl’s ISO 15189 training software empowers labs to establish thorough training programs that meet compliance criteria. Our ISO 15189 software maintains up-to-date and accurate employee training records. In addition, the system notifies personnel when new training tasks are due. 


Enhanced Safety, Decreased Risk


In lab settings, safety rules are a critical part of reducing risks to staff, visitors and customers. Our ISO 15189 software is based on ISO standards to ensure the highest level of lab safety. The MasterControl system is designed to help staff continually identify deficiencies and opportunities for improvement.


Thorough Document Control


All lab processes must be documented. It’s the key to effective quality management. MasterControl ISO 15189 software ensures documentation is complete. The system maintains audit trails of signatures and dates each time a document is changed, reviewed or approved.


MasterControl Simplifies ISO 15189 Compliance

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.

Optimize quality and competence in your laboratory.

See how your lab can achieve the highest level of safety, consistency and performance with a digital QMS.

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