ISO 15189 software

Ensure and evidence quality and competence in medical laboratories with ISO 15189 software.

ISO 15189 logo

What is ISO 15189?

ISO 15189 is the international standard for medical laboratories, specifying the standards for quality and competence to ensure that everything comes together to facilitate accurate and effective diagnosis for every patient.


Why ISO 15189?

ISO 15189 has been highlighted by the government as a priority for medical laboratories to comply with to modernise laboratory practices. The standard is important as it upholds patient safety at its core, ensuring that these vital services are available when needed and produce results to a consistent, high standard.


Spire Healthcare meet ISO 15189 with Q-Pulse

Learn about Spire Healthcare’s experience with using our Q-Pulse product to manage quality and support their processes in order to meet ISO 15189, connecting their 22 different laboratories to work to the same standards.

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The benefits of ISO 15189 software

Using software to manage the requirements of ISO 15189 allows for a more seamless way of working in place of manual, and paper-based processes. It gives you real-time access to all data and allows you to manage multiple activities from one place, saving time and effort.

Improve access to information

Release resources to help improve service quality and reliability.

Manage competency

Verify the competency of management and staff on a regular basis.

Demonstrate compliance

Give on demand proof to regulators of your compliance activities.

Modernise practices

Meet government initiatives to modernise laboratory working practices.

Improve accuracy

Better management of information leads to more consistent results.

Unlock continual improvement

Easily identify opportunities for improvement in the way things are done.



Controlled document management

Gain global access to centralised documents directly from your browser. Easily identify and implement changes or inaccuracies and ensure everyone has access to the latest version.

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Manage audits

Automate the audit lifecycle and reduce the amount of time spent on audit activities. Ensure audit findings are followed up on with automatic notifications, enabling risks to be properly addressed and appropriate actions taken.

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Proactive approach to risk

Analyse incidents in real time and easily notify individuals of areas needing immediate attention to ensure nothing is overlooked. Spend more time addressing opportunities for improvement, rather than reactive activities.

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Manage training and professional development

Save all training records within the system to ensure details can be easily accessed when needed. Identify any gaps in knowledge and competency and set up actions to give individuals the training needed to refresh their skills.

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Unlock continual improvement

Provide continual improvement analysis ‘on demand’ with access to complete up-to-date information in order to identify improvement opportunities, reduce costs and failures through trended root cause analysis.

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The importance of ISO 15189 in laboratories

Our white paper examines the importance of ISO 15189 in the era of Covid-19 and how the right quality management system can improve patient care and diagnostics in line with the standard. 

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See our software in action

Learn more about how our software can support your ISO 15189 compliance. 

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