What is the importance of ISO (International Organization for Standardization) 15189 accreditation for medical laboratories?

Importance of ISO 15189 Accreditation for Medical Laboratories

ISO 15189 accreditation is critically important because it directly improves patient care by ensuring accuracy, reliability, and timeliness of laboratory results, which influence 70% of medical diagnoses and ultimately impact patient morbidity and mortality. 1, 2

Core Definition and Purpose

Quality in medical laboratories is defined as accuracy, reliability, and timeliness of reported results, and ISO 15189 provides the framework to achieve these quality objectives. 1 This international standard is specifically designed for medical laboratories, distinguishing it from more general quality standards like ISO 9001 or ISO 17025. 3

Critical Impact on Patient Outcomes

The importance of ISO 15189 accreditation centers on three fundamental areas:

Direct Patient Safety

• Laboratory results influence 70% of medical diagnoses, making quality laboratory services a major factor directly affecting healthcare quality. 2
• Unreliable laboratory analyses lead to compromised patient care, unnecessary expenditures, and distrust from clinicians and health authorities. 1
• Accredited laboratories enhance credibility and competency of testing services, which translates to better clinical decision-making. 2

Comprehensive Process Coverage

ISO 15189 uniquely addresses all three laboratory phases that affect patient outcomes: 1

• Preanalytical phase: Indication and test selection, sample collection, transport, reception, and accessioning
• Analytical phase: Analysis and quality control procedures
• Postanalytical phase: Interpretation, reporting, record keeping, and timely notification

This comprehensive approach recognizes that errors in any phase can compromise patient care, not just analytical errors. 3

Technical Competence and Quality Systems

ISO 15189 is the only international standard that recognizes both the importance of technical competence AND quality management systems specifically for medical laboratories. 3 This dual focus ensures laboratories are not just following procedures, but are actually competent to perform the testing they offer.

Regulatory and Professional Recognition

• ISO 15189 is the standard for accreditation of medical laboratories in Europe and is increasingly recognized globally as the most appropriate standard for medical laboratory accreditation. 1, 3
• The standard provides formal recognition that a medical laboratory is competent to carry out specific tasks. 1
• Many countries including England, Germany, France, Canada, and Australia have adopted ISO 15189 as their laboratory accreditation program. 4

Quality Improvement Framework

The standard drives continuous improvement through: 1, 3

• Method validation ensuring tests are fit for purpose
• Quality indicators (QIs) as fundamental requirements for monitoring performance
• Internal and external quality control programs to maintain consistency
• Management reviews and audits to identify areas for improvement
• Competence assessment of personnel through job descriptions, training, and re-assessment routines 1

Global Health Impact

In low-resource settings, ISO 15189 accreditation has been particularly transformative. 1

• A decade ago, medical laboratories in sub-Saharan Africa were described as a "barrier to healthcare" with unreliable analyses. 1
• Accreditation according to ISO 15189 quality standards was pledged as part of global efforts to strengthen laboratory health systems, with programs like WHO-AFRO's SLIPTA (Stepwise Laboratory Quality Improvement Towards Accreditation) preparing laboratories for ISO 15189 accreditation. 1
• The number of accredited laboratories in sub-Saharan Africa increased from 380 in 12 countries (2013) to 485 in 18 countries (2017). 1

Critical Role in Antimicrobial Resistance and Public Health

ISO 15189 accreditation is essential for addressing antimicrobial resistance (AMR) and outbreak management. 1

• The AMR crisis requires reliable bacterial identification and antimicrobial susceptibility testing, which depends on quality-assured laboratory processes. 1
• The 2014-2015 West African Ebola outbreak highlighted how weak diagnostic infrastructure compromises public health responses. 1
• International initiatives like the Global Health Security Agenda recognize accredited laboratories as critical for global health security. 1

Common Pitfalls to Avoid

Accreditation should focus on patient value rather than technical details alone. 1 One frequent pitfall is that accreditation can focus excessively on quality and technical requirements while potentially overlooking the end goal of patient care. 1

The standard must be implemented with the basic requirement of achieving actual contribution to patient care—every quality assurance initiative must maintain perspective that patient care is the ultimate goal. 1