Insights on updated accreditation guidelines ISO 15189:2022

Accreditation by the International Organization for Standardization (ISO) demonstrates that the certified organization operates according to internationally recognized standards for competence and impartiality.¹ ISO 15189 is the ISO standard for medical laboratories, and while certification is not mandatory, achieving accreditation reassures stakeholders that a laboratory operates in a credible manner.² 

Revised ISO 15189 guidelines were published in December 2022, and The International Laboratory Accreditation Cooperation requires organizations with existing accreditation to transition to the new standard within three years of publication, by the end of 2025.³ At Roche Experience Days (RED) 2024, Kao Chih-Hsiung, Director of Laboratory at St Martin de Porres Hospital in Taiwan, gave an overview of how their hospital’s lab is working towards implementing the updated guidelines.

ISO 15189 was last revised in 2012, and since then there have been significant advances in laboratory practices, such as increasing use of automated systems and computer technology, meaning change was required.⁴ As Director Kao notes, “ISO 15189 is rather late for change and adjustment”.

According to the ISO, the objective of the updated document is to ‘promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories’. It outlines the requirements of the lab to plan and implement actions to address risks and details opportunities for improvement.⁵

Although the existing requirements of the standard are largely unchanged, there are some key changes that Director Kao outlines, “The document has been referenced to ISO/IEC 17025:2017 (for testing and calibration laboratories) and changes made accordingly to align the standards. Secondly, requirements for point of care (POC) testing, previously in ISO 22870, have been incorporated, and thirdly, increased emphasis on risk management and patient care has been highlighted”.

Although laboratory-supported point of care testing is a completely new addition to the standard, for Director Kao, “The biggest change is the risk management”. This is also the view of the United Kingdom Accreditation Service, who note that requirements throughout the document are ‘designed to ensure that the risk to patients is central to the ethos of the laboratory’s quality management design and processes’.⁶

In other words, clinical labs now bear the responsibility of carrying out risk management for all activities that pose a risk to patients to ensure the best possible outcomes across the entirety of the testing process. Director Kao uses the example of labs embracing new technologies like machine learning or generative AI to improve turnaround times on lab reports. “Every coin has two sides,” Kao explains, “If we are introducing new technology to improve efficiency and efficacy, we also need to control any related risks, and with AI, there are some governance risks to consider.”

To understand whether the hospital’s lab had to make any changes based on the updated guideline, Director Kao worked through several steps with the wider team: 

1. Kickoff meeting: a project team was formed, and tasks were divided according to personnel expertise, including thoroughly reading and understanding the changes in the revised ISO.
2. Gap analysis: the team looked at new requirements and compared these to the current status of their quality system.
3. Decide to change: the gap analysis was then discussed, and the management team decided whether any changes would need to be made.
4. In-house transition plan: based on the management decisions, the team came up with a transition plan that included a to-do checklist detailing each change, the schedule for change, and the personnel responsible.
5. Implement changes: with the transition plan in place, changes were then implemented to the laboratory management system, including any personnel training required.
6. Monitor changes: lastly, changes made were monitored to ensure the lab was able to achieve the new requirements.

Throughout this process, the lab kept six healthcare quality goals in mind, aiming to be: safe, effective, patient-centered, timely, efficient, and equitable. “We want to provide patients with an efficient, safe, and accurate service. The most important goal of risk management is to achieve this target. There should be evidence behind any change made because there are patients’ lives in our hands,” says Director Kao.

While ISO 15189 accreditation can be a long process, the ISO lists several benefits of adopting the approach, including: increasing the overall effectiveness of management systems, decreasing the probability of invalid results, and reducing potential harm to patients, laboratory personnel, the public, and the environment.⁵ By demonstrating a commitment to quality and continuous improvement, laboratories may also benefit from new business opportunities and access to new markets.¹

To hear more from Director Kao about the hospital’s experience of implementing the updated guidelines, click here to watch the full RED 2024 presentation.