Why is ISO 15189 important?

10th June 2021

Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation.

With 300,000 tests performed every working day of the year and around 95% of clinical pathways relying on patients having access to pathology services, it’s clear that medical laboratories sit at the heart of a fully-functional modern society. Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality and capabilities. Here’s a little bit more about this crucial ISO standard.

What is ISO 15189?

 ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards.

As part of your ISO 15189 accreditation process, you will create a document that explains how your laboratory can work to conform to each requirement to a high standard of quality. This handy document will provide each member of your team with instructions for performing the tasks to an ISO-accredited standard.

Who needs ISO 15189?

Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.

What are the benefits of ISO 15189 accreditation?

There are many reasons why ISO 15189 is important – here are some of the numerous benefits it offers to medical laboratories.

Risk Reduction

When you structure your operation around best practise, your systems will be more rigorous. Planning for and identifying any potential risks will help massively reduce them – especially in laboratories that deal with sensitive information, complicated equipment and matters pertaining to people’s health.


By assuring results are technically valid, your laboratory will save costs associated with retesting. There will also be other cost-saving measures implemented across the standard as your efficiency increases.

Improved team morale

The standard works to reduce staff mistakes and other preventable errors. Your staff motivation won’t only be improved by their demonstration of better performance, but also by you recognising and promoting your staff’s technical competence.

Legally compliant

By implementing legislation and industry standards into your medical laboratory, ISO 15189 assures that your clinical services are safe, reliable and of good value. This conveys trust to stakeholders and decision-makers who recognise and appreciate the commitment. Legal challenges will be less likely and, if they do occur, you can ensure the framework will support you.

Continual improvement

Best practices won’t start and end with your ISO 15189 certification: through integrating this framework into the core of what you do, you will develop additional programmes over time. The framework acts as a tool for measuring quality improvements and continually supporting consistency.

Globally recognised

Being a globally recognised standard not only has reputational benefits. For ISO 15189, global recognition is particularly pertinent. A series of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the world. This way, your work can benefit medical health not just in your country, but all over the globe.

Article written by Medilink Midlands member IMSM Ltd. For further information please contact David Coulter, Area Manager, davidcoulter@imsm.com +44 (0) 7786 064 911

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