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Spotlight on accreditation standards: ISO 15189 – Medical Laboratories

Medical laboratories play a critical role in the delivery of healthcare services, providing essential diagnostic tests and monitoring treatment progress. To ensure the reliability, competence, and overall quality of these laboratories, ISO 15189 accreditation is a mark of confidence that verifies their adherence to international standards.

What is ISO 15189?

ISO 15189 Medical Laboratories – Requirements for quality and competence is an international standard that specifies the requirements for quality and competence in medical laboratories. It provides a framework for the development of a robust quality management system (QMS) and ensures that laboratories operate in line with industry and legal standards. Unlike ISO 9001, which sets out criteria for quality management systems in any organisation, ISO 15189 specifically focuses on the unique requirements of medical laboratories.

The standard covers a wide range of disciplines, including clinical biochemistry, toxicology, haematology, blood transfusion, microbiology, virology, parasitology, serology, histopathology, cytology, mortuaries, immunology, genetics, andrology, and histocompatibility & immunogenetics, as well as point-of-care testing services.

Importance of ISO 15189 accreditation

While ISO 15189 accreditation is not mandatory in every jurisdiction, its significance should not be underestimated, especially in the field of public health. Accreditation serves as a mark of competence, demonstrating a laboratory’s dedication to delivering proficient and high-quality services. It provides several key benefits that contribute to the overall success and reputation of medical laboratories.

Confidence in competence

ISO 15189 accreditation verifies a laboratory’s integrity, impartiality, and capability. It assures stakeholders, including patients, healthcare providers, and regulatory bodies, that the laboratory meets stringent requirements for quality and competence. Accreditation serves as a mark of confidence, instilling trust in the laboratory’s ability to deliver accurate and reliable results.

Risk reduction

Implementing ISO 15189 requirements helps laboratories identify and manage risks associated with their operations. By following best practices and planning for potential risks, laboratories can significantly reduce the likelihood of errors, equipment malfunctions, and other issues that may compromise patient safety or the accuracy of test results. Proactive risk management is especially crucial in medical laboratories, where the well-being of patients is at stake.

Cost savings

ISO 15189 accreditation promotes efficiency and cost savings in laboratory operations. By ensuring that test results are technically valid, laboratories can reduce the need for retesting, saving both time and resources. Additionally, the implementation of efficient practices and processes, as required by the standard, can help laboratories optimise their workflows and minimise wastage, resulting in significant cost savings over time.

Improving team morale

ISO 15189 emphasises the importance of staff competence and continuous improvement. By implementing the standard’s requirements, laboratories can reduce staff mistakes and preventable errors, leading to improved team morale. Recognising and promoting technical competence among staff members fosters a culture of quality and professionalism, further enhancing the laboratory’s reputation and overall performance.

Continual improvement

ISO 15189 accreditation is not a one-time achievement but rather a commitment to continual improvement. The standard provides a framework for laboratories to measure and monitor their quality improvements over time. By integrating ISO 15189 into their core operations, laboratories can develop additional programs and initiatives that drive further enhancements in quality, consistency, and patient care outcomes.

Global recognition

ISO 15189 is a globally recognised standard, providing laboratories with international recognition for their commitment to quality and competence. Through multilateral mutual recognition arrangements within the International Laboratory Accreditation Cooperation (ILAC), laboratories accredited to ISO 15189 have their certificates and test reports accepted in over 80 countries worldwide. This global recognition allows laboratories to contribute to medical health not only within their own country but also on a global scale.

The accreditation process

The process of gaining ISO 15189 accreditation involves several steps, ensuring that laboratories meet the standard’s requirements and demonstrate their competence to the appropriate national accreditation body, which is UKAS in the case of the United Kingdom.

The accreditation process typically begins with a conversation, in which the potential applicant will speak with personnel at UKAS, including an Assessment Manager appropriate to their technical area. This conversation will establish the readiness of the laboratory to embark on accreditation. The next stage involves the completion of an application form, which includes details of the laboratory’s policies, procedures, and proof of legal status. Once the application is submitted, a pre-assessment or audit gap analysis may be conducted to identify any significant issues that need to be addressed before the formal assessment.

The assessment phase involves a detailed examination of the laboratory’s operations, processes, and quality management system. The assessment is carried out by experts in the field, who possess technical knowledge and insight into the laboratory’s specific tests and procedures. The duration of the accreditation process can vary depending on the laboratory’s existing quality management systems and the complexity of the assessment.

Once accredited, laboratories enter a four-year accreditation cycle, during which UKAS conducts regular checks to ensure ongoing compliance with ISO 15189. These annual surveillance checks are followed by periodic full re-assessments, typically every four years, to renew accreditation.

Transition to the 2022 version of the ISO 15189 standard

In December 2022, a revised version of ISO 15189 was published, bringing refinements, clarifications, and changes to the previous 2012 version. The transition to the 2022 version of ISO 15189 may require laboratories to update their quality management systems and align their practices with the new requirements.

The International Laboratory Accreditation Cooperation (ILAC) has agreed that there shall be a three-year transition period; by the end of which providers accredited to ISO 15189:2012 worldwide must have been assessed and accredited to ISO 15189:2022.

To facilitate the transition, various resources and training programs are available from the UKAS Training Academy. These programs provide laboratories with knowledge and best practices for implementing the 2022 version of ISO 15189 and ensuring compliance with the updated standard. An information hub for Medical Laboratories approaching the transition is also available on the UKAS website.

UKAS accreditation and quality in the UK healthcare sector

UKAS accreditation ensures that medical laboratories meet the relevant requirements of ISO 15189 and operate a quality management system that demonstrates competence and adherence to the standard. It provides independent verification of a laboratory’s integrity, impartiality, and capabilities, instilling confidence in the laboratory’s services among stakeholders.

The UK healthcare sector depends on high quality services to support patient care and safety. UKAS accreditation provides assurance that laboratories comply with the standard’s requirements, contributing to the overall quality and reliability of healthcare services in the UK.

In summary, ISO 15189 accreditation is a mark of confidence that verifies the competence and quality of medical laboratories. UKAS accreditation ensures that laboratories in the UK meet the relevant requirements of ISO 15189 and operate with integrity, impartiality, and competence. Accreditation provides numerous benefits, including risk reduction, cost savings, improved team morale, , and global recognition. The accreditation process, overseen by UKAS, involves rigorous assessment and ongoing surveillance to maintain compliance with the standard. By adhering to ISO 15189 and gaining UKAS accreditation, medical laboratories demonstrate their commitment to delivering high-quality healthcare services and contributing to the overall quality of the UK healthcare sector.