ISO 15189: From a Technical Standard to the Foundation of Patient Safety

ISO 15189: From a Technical Standard to the Foundation of Patient Safety

A historical, institutional, and contemporary perspective

Giorgi Pkhakadze, MD, MPH, PhD Introduction

Medical laboratories are among the most critical yet often least visible components of modern healthcare. It is widely recognised that 60–70% of clinical decisions are informed by laboratory test results, spanning prevention, diagnosis, treatment, and long-term disease management. Despite this central role, for much of the twentieth century laboratory quality assurance evolved in a fragmented and inconsistent manner. Organisational quality systems, technical competence, and patient safety were frequently addressed as separate domains, resulting in variability in test reliability and, in some cases, preventable patient harm.

The emergence of ISO 15189 represented a decisive response to this challenge. By creating a single, internationally recognised framework tailored specifically to medical laboratories, ISO 15189 bridged the long-standing gap between quality management and technical competence. Over time, the standard has evolved well beyond its original technical scope, becoming a cornerstone of patient safety, clinical reliability, and health system trust [1].

This article provides an expanded examination of the historical origins of ISO 15189, the role of international organisations—particularly the World Health Organization (WHO)—and recent developments, including updated accreditation requirements from Accreditation Canada Diagnostics (AC Diagnostics). The discussion also situates ISO 15189 within the Georgian health system context, where laboratory quality has become an explicit policy priority.

Historical Background: Laboratory Quality Before ISO 15189

Before the early 2000s, laboratory quality assurance was shaped largely by national traditions, professional norms, and generic management standards. Many laboratories sought certification against ISO 9001, a quality management standard originally developed for industrial production and service organisations. ISO 9001 helped standardise documentation, corrective actions, and management review processes, but it was never designed to address the scientific and clinical complexities of laboratory medicine.

At the same time, professional societies issued discipline-specific guidelines focusing on analytical performance, but these lacked consistent international recognition and were rarely subjected to independent external assessment. As a result, two laboratories performing the same test in different countries—or even within the same country—could operate under vastly different quality assumptions. From a patient safety perspective, this variability represented a significant and largely unaddressed risk.

The increasing globalisation of healthcare, expansion of cross-border research, and growing reliance on laboratory diagnostics in public health surveillance made these limitations increasingly untenable. A new approach was needed—one that recognised laboratories not merely as technical service units, but as clinical actors whose outputs directly influence patient outcomes.

The Birth of ISO 15189: A Paradigm Shift

To address this gap, experts working within the International Organization for Standardization (ISO) developed a new standard specifically for medical laboratories. First published in 2003, ISO 15189 was groundbreaking in that it combined quality management requirements with technical and professional competence, explicitly acknowledging the clinical responsibility inherent in laboratory medicine [1].

This integration represented a paradigm shift. For the first time, laboratory quality was framed as a measurable, externally verifiable contributor to patient safety. Accreditation under ISO 15189 was not simply about organisational orderliness; it was about ensuring that laboratory results were fit for clinical purpose. The standard introduced expectations related to staff competence, method validation, equipment control, result reporting, and continuous improvement—elements that directly influence diagnostic accuracy.

Early Adoption and Cultural Transformation

Initial adoption of ISO 15189 was cautious. Many laboratories perceived accreditation as resource-intensive and administratively burdensome. Concerns were particularly pronounced in low- and middle-income settings, where workforce shortages and infrastructure constraints posed real challenges. However, laboratories that embraced ISO 15189 early began to demonstrate tangible benefits.

Accreditation revealed hidden system vulnerabilities, clarified responsibilities, improved traceability of results, and strengthened communication between laboratories and clinicians. Perhaps most importantly, it catalysed a cultural shift: quality became a shared professional responsibility rather than a managerial formality. These early experiences reinforced a key insight that continues to shape the standard today—quality systems are meaningful only when aligned with clinical risk.

The Influence of WHO: Laboratory Quality as a Public Health Imperative

The evolution of ISO 15189 cannot be understood without recognising the influence of the WHO. Over the past two decades, WHO has consistently emphasised laboratories as foundational to effective health systems, disease surveillance, outbreak response, and antimicrobial resistance monitoring. Weak laboratory quality, WHO argued, undermines not only individual patient care but also population-level health security.

WHO’s Laboratory Quality Management System (LQMS) framework articulated principles that closely mirror those later embedded in ISO 15189: control of the total testing process, risk-based thinking, competence-based training, and continuous improvement [2]. Through technical guidance, global training programmes, and policy advocacy, WHO helped elevate laboratory quality from a technical concern to a public health and patient safety priority.

In many countries, ISO 15189 became the operational mechanism through which WHO’s laboratory quality principles were implemented. This alignment reinforced the legitimacy of the standard and accelerated its global adoption.

Maturation of ISO 15189: From Structure to Risk and Outcomes

Revisions of ISO 15189 in 2007 and 2012 expanded the standard’s scope beyond structural compliance. Risk management, method validation, equipment lifecycle control, and staff competence were strengthened, while increasing attention was paid to pre-analytical and post-analytical phases—where the majority of laboratory errors occur.

These revisions reflected growing evidence that analytical excellence alone is insufficient to ensure patient safety. Errors in patient identification, sample collection, transportation, result interpretation, and communication can have consequences as severe as analytical failures. ISO 15189 increasingly emphasised the total testing cycle, reinforcing the laboratory’s role within the broader clinical care pathway.

ISO 15189:2022 — A Patient-Centred, Risk-Based Standard

The publication of ISO 15189:2022 marked the most mature and clinically oriented iteration of the standard to date [1]. The revised version formally embeds risk-based thinking, leadership accountability, and ethical practice into laboratory operations. Key features include:

• Explicit integration of pre-analytical and post-analytical processes

• Systematic management of measurement uncertainty

• Clear requirements for communication of critical results

• Strong emphasis on patient safety, data integrity, and confidentiality

• Recognition of laboratories as integral components of clinical care pathways

The conceptual shift is profound. ISO 15189:2022 reframes the laboratory from a technical service provider into a clinical partner whose performance directly affects diagnosis, treatment, and outcomes. Compliance is no longer the endpoint; the ultimate goal is a sustainable quality culture.

Accreditation Canada Diagnostics: Translating Standards into Practice

While ISO standards define what should be achieved, accreditation programmes define how those requirements are assessed in practice. A notable recent development is the release of 15189 ISO Plus™ Medical Laboratory Accreditation Requirements, Version 9.1 (June 2025) by AC Diagnostics [6].

This update reflects changes in reference standards, legislation, and stakeholder feedback, ensuring alignment with ISO 15189:2022. Key enhancements include:

• Integration of point-of-care testing (POCT) across core laboratory requirements following withdrawal of ISO 22870

• Strengthened guidance for digital pathology validation and verification

• Updated requirements for molecular diagnostics, aligned with the latest CLSI guidance

• Clarified responsibilities related to laboratory information systems (LIS)

By continuously updating its requirements, AC Diagnostics demonstrates how accreditation can remain responsive to scientific and technological change while maintaining patient safety as the central objective.

Evidence of Impact: Quality, Safety, and Trust

A growing body of international evidence links ISO 15189-based accreditation to improved laboratory performance. Accredited laboratories report lower error rates, improved result consistency, and stronger clinician confidence [2,3]. Accreditation also facilitates benchmarking and peer review, enabling laboratories to identify weaknesses and implement corrective actions systematically.

Importantly, ISO 15189 promotes a non-punitive approach to error management, encouraging root cause analysis rather than individual blame. This aligns with contemporary patient safety principles and has been shown to improve staff engagement, transparency, and organisational learning [3].

The Georgian Context: ISO 15189 as a Strategic Tool

In Georgia, laboratory quality has emerged as a strategic priority within broader health system reforms. The Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia has recognised the importance of aligning laboratory services with international standards, including ISO 15189, as part of national quality improvement initiatives [5].

This policy direction responds to increasing demand for reliable diagnostics in infectious disease surveillance, antimicrobial resistance monitoring, oncology, and chronic disease management. ISO 15189-based accreditation strengthens domestic trust in laboratory results while facilitating international cooperation, research participation, and cross-border health security.

Georgia’s experience underscores a critical lesson: accreditation is most effective when accompanied by professional education, leadership commitment, and supportive institutional frameworks. Accreditation alone does not create quality; it enables it.

Challenges and Future Directions

Despite its strengths, ISO 15189 implementation faces ongoing challenges. Resource constraints, workforce capacity issues, and varying levels of institutional readiness can hinder meaningful adoption. There is also a risk of superficial compliance if accreditation is pursued solely for certification rather than improvement.

Looking ahead, ISO 15189 must continue adapting to rapid technological advances, including automation, digital pathology, and artificial intelligence. These innovations introduce new risks related to data integrity, algorithmic transparency, and clinical accountability. The risk-based architecture of ISO 15189:2022 provides a robust foundation for addressing these challenges, but sustained guidance, interpretation, and leadership engagement will be essential.

Conclusion

ISO 15189 has undergone a remarkable transformation. What began as a technical standard has become a foundation of patient safety and health system trust. Its evolution reflects the combined influence of international standard-setting bodies, WHO’s public health leadership, and accreditation organisations that translate standards into practice.

For countries such as Georgia, ISO 15189 represents more than compliance—it is a strategic instrument for strengthening diagnostics, supporting clinicians, and protecting patients. Ultimately, the true value of ISO 15189 lies not in accreditation certificates, but in its capacity to ensure that laboratory results—on which lives depend—are accurate, timely, and trustworthy.

References

1. International Organization for Standardization. ISO 15189:2022 Medical laboratories — Requirements for quality and competence. Geneva: ISO; 2022.

2. World Health Organization. Laboratory quality management system handbook. Geneva: WHO; 2011.

3. Plebani M. Errors in laboratory medicine and patient safety: the road ahead. Clin Chem Lab Med. 2018;56(10):1709–1714. doi:10.1515/cclm-2018-0142.

4. International Laboratory Accreditation Cooperation. The role of accreditation in improving laboratory quality and patient safety. ILAC guidance documents.

5. Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. National directions for improving laboratory service quality. Tbilisi; official policy documents.

6. Accreditation Canada Diagnostics. 15189 ISO Plus™ Medical Laboratory Accreditation Requirements, Version 9.1 (June 2025). Ottawa: AC Diagnostics; 2025.

Author:

Giorgi Pkhakadze, MD, MPH, PhD is Professor of Public Health at David Tvildiani Medical University and Chair of the Public Health Institute of Georgia (PHIG). He is the Chief Editor of the Georgian Medical Journal (GMJ.ge) and an internationally recognised public health expert with more than 25 years of experience in health systems strengthening, laboratory quality management, accreditation, and evidence-based health policy across Georgia, Europe, and global health institutions.

Each article is made available under the terms of the Creative Commons Attribution–Non Commercial 4.0 License.