Aligning with ISO 15189: The Complementary Roles of LIMS and Preservation Systems 

Ensuring that laboratory records remain accurate, accessible, and trustworthy over time is essential for patient safety, regulatory compliance, and audit readiness. While Laboratory Information Management Systems (LIMS) are central to laboratory workflows, relying on them alone for long-term data retention can introduce risk. 

Understanding ISO 15189 in Practice 

ISO 15189 sets out the requirements for quality and competence in medical laboratories, covering areas such as personnel, processes, equipment, and data management. Within this framework, laboratories must ensure that data is traceable, secure, and retained for defined periods. Importantly, ISO 15189 accreditation applies to laboratories, not to software products. 

Systems such as LIMS are therefore not “ISO 15189 certified” in themselves but are typically designed to support ISO 15189 compliance by helping laboratories meet these requirements in practice. 

While LIMS plays a critical role in managing laboratory data, it is primarily designed for active workflows. It may not always be optimised for ensuring that records remain retrievable, protected, and reliable over extended periods. As a result, “fit for purpose” across the full data lifecycle becomes an important consideration. 

A Real-World Example: Patient Results and QC Data 

Imagine a scenario where a clinician questions a patient result from several years ago. The laboratory must not only retrieve the reported result but also demonstrate that the testing system was performing correctly at the time. This often requires access to historical quality control (QC) data, which laboratories may retain for a defined period associated with a reagent lot or testing period. 

Using this QC data as a reference helps bring the story to life. It shows why historical records matter, ensuring confidence in both the patient result and the method used at the time. 

In this scenario, the laboratory must ensure that: 

• The patient result is still accessible and accurately recorded 

• Supporting QC data is available to demonstrate instrument and method reliability 

• All records are protected from unauthorised changes and remain interpretable in their original context 

This example highlights the importance of long-term data preservation. In practice, retention periods are defined by regional regulatory requirements, with the laboratory’s data lifecycle strategy ensuring that these obligations are met. 

The Role of LIMS 

LIMS is essential for managing laboratory data during active operations. It supports sample tracking, workflow control, data capture, and reporting, ensuring that processes are traceable and results are consistently recorded. 

However, long-term access to records especially years later can be more challenging if data is stored only within the LIMS. System upgrades or infrastructure changes may complicate retrieval, and ensuring that data remains unchanged and readable over time is not always straightforward. 

The Role of Preservation Systems 

Preservation systems take records out of the operational environment and ensure they remain accessible, secure, and trustworthy over the long term. 

These systems enforce retention policies, protect against unauthorised modification, and verify data integrity over time. They also help manage technological change, ensuring that historical results and QC data remain readable and interpretable as systems evolve. 

In the patient result scenario, a preservation system ensures that both the reported result and the supporting QC data can be confidently retrieved years later, supporting ISO 15189 compliance. 

Why Many Laboratories Use Both 

ISO 15189 requires laboratories to manage data across its full lifecycle from creation to long-term retention. 

• LIMS supports the creation and active use of data, ensuring processes are controlled and traceable 

• Preservation systems support the retention phase, helping ensure records remain accessible and reliable over extended periods 

Together, they provide a robust approach to meeting ISO 15189 expectations, particularly when long retention periods or system changes are involved. 

Conclusion 

ISO 15189 makes it clear that laboratory data must remain reliable, accessible, and secure beyond its point of creation. While LIMS systems are essential for managing day-to-day laboratory operations, long-term retention introduces additional challenges especially for records that may need to be revisited years later, such as patient results and supporting QC data. 

By combining LIMS with a dedicated preservation approach, laboratories can reduce risk, improve audit readiness, and strengthen their overall compliance ensuring that both active and historical data are reliably preserved for the full required retention period.