What is ISO 15189: A Guide

Accreditation to an ISO standard serves as formal recognition that a testing laboratory or other organisation meets internationally recognised standards for competence and impartiality.

Achieving ISO accreditation assures customers, regulators, and other stakeholders that the organisation operates with expertise, fairness, and adherence to established standards. This ensures reliable laboratory testing and accurate results.

At UK NEQAS IIA, our mission is to support medical laboratories in attaining and sustaining ISO 15189 accreditation. We achieve this through our ISO 17043* accredited EQA schemes, which are designed to ensure excellence and compliance with international standards. Keep reading to learn more about ISO 15189, and how it can benefit laboratories. 

This guide explores what ISO 15189 is, what the ISO 15189:2022 standards involve, and how laboratories can work towards ongoing compliance and accreditation.

What are the ISO 15189 Standards?

ISO 15189 is a globally recognised quality standard for the competence of medical laboratories. Unlike ISO 17025, which applies to general testing and calibration laboratories, ISO 15189 addresses the distinct needs and requirements of medical laboratories. ISO 15189 covers the pre-analytical, analytical, and post-analytical phases of testing.

The ISO 15189 framework outlines the requirements that should be established and maintained for quality management and technical procedures, and is designed to ensure high quality of laboratory testing for patient samples. Although the ISO 15189 is not essential for laboratories, it is widely recognised as an important benchmark for quality, competence, and patient safety.

Why is it Important for Laboratories?

The ISO 15189 standard is important because it provides detailed guidance for establishing and maintaining a quality management system. This ensures laboratories consistently produce accurate and reproducible patient results.

In addition, ISO 15189 helps standardise the quality of medical laboratory services globally, ensuring that laboratories adhere to the same high standards of quality across different countries.

What Does ISO 15189:2022 Cover?

The latest version of the standard (ISO 15189:2022) places a stronger emphasis on risk management, patient safety, laboratory competence, and continual improvement. ISO 15189:2022 encourages laboratories to move beyond simple compliance by embedding risk-based thinking into daily laboratory practice.

The framework covers all stages of the testing pathway, including:

• Pre-analytical processes such as sample handling and preparation  
• Analytical procedures and method performance  
• Post-analytical reporting and interpretation  
• Laboratory quality management systems  
• Staff competence and training  
• Equipment validation and maintenance  
• Risk assessment and corrective actions

ISO 15189:2022 also encourages laboratories to adopt a more proactive approach to quality management, helping identify issues earlier and strengthen long-term reliability.

ISO 15189:2022 vs ISO 15189:2012

The 2022 revision of ISO 15189 introduced several updates intended to modernise laboratory quality management and place greater emphasis on risk-based thinking, patient safety, and continual improvement.

Whilst ISO 15189:2012 focused heavily on procedural compliance and documentation, ISO 15189:2022 encourages laboratories to take a more flexible and proactive approach to identifying, managing, and mitigating risk throughout the testing process.

Key areas include greater emphasis on risk management and opportunities for improvement, increased focus on patient impact and clinical relevance, and stronger integration of information management and digital systems.

Laboratories transitioning from ISO 15189:2012 to ISO 15189:2022 may need to review quality management systems, training procedures, documentation structures, and risk assessment processes to ensure ongoing compliance with UKAS requirements and international accreditation standards.

Participation in structured EQA programmes can also support laboratories in demonstrating ongoing quality assurance and continual improvement during transition to ISO 15189:2022.

What are the Benefits of Having ISO 15189 Accreditation?

Reducing Risk

ISO 15189 simplifies the identification of potential risks, enabling medical labs to proactively plan and implement preventive actions for enhanced quality and patient safety. This supports more proactive decision-making, helping to reduce errors, improve patient safety, and strengthen confidence in reported results.

Improved Efficiency

By encouraging clear processes, documented procedures, and defined responsibilities, ISO 15189 allows medical labs to streamline processes, which can help build efficiency and productivity.

Greater Confidence in Patient Results

ISO 15189 supports the delivery of accurate, consistent, and clinically reliable results. This helps clinicians make informed decisions and supports high standards of patient care.

Better Quality Management

The standard requires laboratories to establish a robust and consistent quality management system (QMS) to demonstrate their competence, enabling medical labs to quickly identify errors and implement corrective actions efficiently, minimising impact on patient care.

Participation in structured EQA programmes, such as those available across our Immunochemistry, Autoimmunity, Oncology, and Allergy categories, supports ongoing compliance with ISO 15189 requirements.

International Recognition

As an internationally recognised standard, ISO 15189 helps demonstrate that a laboratory operates to accepted levels of quality and competence, giving confidence to regulators, clinicians, service users, and partner organisations.

Saves Money and Time

Implementing more efficient practices can help avoid expensive mistakes as well as saving time trying to rectify them. 

Advantages Over Competitors

Achieving ISO 15189 accreditation gives laboratories an edge above their competitors by showcasing commitment to dependable in laboratory practices.

How Do You Get an ISO 15189 Certification?

The application process is typically conducted online. In the UK, ISO 15189 accreditation is awarded by the United Kingdom Accreditation Service (UKAS). Globally, other accrediting bodies include the International Accreditation Service (IAS) and the College of American Pathologists (CAP). 

After submitting your application, a pre-assessment will be conducted by UKAS (or other relevant body). During this stage, your processes will be reviewed, and any issues that need to be resolved before proceeding to the full assessment will be identified. This step helps ensure your readiness and addresses potential gaps early in the accreditation process, and is sometimes referred to as the ‘audit gap analysis’. 

Following this, you will undergo a formal audit conducted by experts in the field to evaluate your compliance with the criteria of ISO 15189. This thorough evaluation ensures all standards are met. The certification process typically takes between 3 and 6 months to complete.

Maintaining an ISO 15189 Certification

After achieving accreditation, you will enter a surveillance period. During this time, UKAS will conduct annual reviews of your processes to ensure ongoing compliance with ISO 15189 standards. These regular check-ins help maintain the integrity of your accreditation and ensure that high standards are consistently upheld.

ISO 15189 vs ISO 17025

Whilst both ISO 15189 and ISO 17025 relate to forms of formal recognition standards for laboratory competence, they are designed for different use cases.

ISO 15189 applies specifically to medical laboratories and places a strong emphasis on patient care, clinical relevance, quality management, and the full diagnostic pathway.

ISO 17025, by comparison, is a broader standard used for testing and calibration laboratories across a wide range of industries and does not specifically address the clinical and patient-focused requirements of medical laboratory services.

For laboratories involved in patient diagnostics, ISO 15189 is generally considered the more appropriate accreditation standard.

How UK NEQAS IIA Supports ISO 15189 Accreditation

We’ve explored what ISO 15189 is, what the ISO 15189:2022 standards involve, and how it can benefit laboratories.  At UK NEQAS IIA, we offer expert guidance and support to help laboratories achieve and maintain the highest standards of quality, reliability, and trustworthiness.

Our ISO 17043 accredited EQA schemes help laboratories demonstrate ongoing performance, identify areas for improvement, and support compliance with ISO 15189 and UKAS requirements. Explore our EQA programmes to find the most relevant scheme for your laboratory or contact us today for more information. You can also visit our Digital Academy to access a range of educational resources that support continued professional development and quality improvement.