LIMS Feature
Using LIMS to Support ISO 17025 Accreditation (Driving out cowboy working practices)
Dr Phil Williams,
Phil@lims4u.co.uk
ISO/IEC 17025:2017 [1] is an internationally recognised standard that defi nes the general requirements for the competence of testing and calibration laboratories. The standard emphasises the need for laboratories to demonstrate their competence and ability to generate valid results. The standard doesn’t provide prescriptive guidelines, but encourages a risk-based approach. This involves assessing risks associated with the standard’s provisions and minimising them. Effective management of the laboratory process, resources, and data is essential in achieving this. ISO17025 plays a key role in ensuring that a laboratory’s customers can be confi dent in the quality of their results.
This article explores how an Laboratory Information Management System (LIMS) can be integrated into the daily operations of a laboratory to play a key role in achieving, maintaining, and benefi ting from ISO17025 accreditation.
Traditionally LIMS have focussed on managing samples, tests, and results, while ISO17025 says surprisingly little about this. Section 7.5 of ISO17025 states that technical records should include the date, person responsible, calculations, and identity of the person checking the data. Amendments to these records also need to be checked. However, other sections of the standard show how a modern integrated LIMS can support ISO 17025 requirements.
ISO17025 Section 6 concentrates on managing laboratory resources, including personnel, facilities, equipment, systems, and support services. An integrated LIMS can play a crucial role in meeting these requirements.
Personnel (Section 6.2)
Section 6.2 of the standard focuses on personnel, specifi cally staff competency and training. The standard requires documenting competency requirements for functions that impact laboratory results without specifying those functions explicitly. It emphasises that personnel must be competent to perform their assigned activities. While staff competency and training might seem unrelated to LIMS, an integrated LIMS can effectively manage staff training and competency records.
Furthermore, the LIMS should link these records to specifi c activities to prevent unqualifi ed personnel from performing them. For example, the system can verify the user’s competency during analysis and stop them entering results if they lack the necessary training or certifi cation. This principle can also extends to activities such as instrument maintenance and calibration.
Facilities and environmental conditions (Section 6.3)
At fi rst glance, it may seem unlikely that Laboratory Information Management Systems (LIMS) can play a signifi cant role in managing facilities and environmental conditions within the scope of ISO17025. However, as LIMS functionality can include the monitoring, control, and recording of environmental conditions that may impact result validity, its role becomes clearer. LIMS goes beyond recording results and includes managing the monitoring process itself. Sampling location can be defi ned and mapped and sampling schedules set up Results that exceed defi ned contamination limits are fl agged, and data trends monitored over time. These capabilities are especially valuable for monitoring contamination in clean environments.
Figure 2. An example of Environmental Monitoring in a LIMS. Equipment (Section 6.4) Figure 1. An example of Staff Competency tracking screen in LIMS.
Section 6.4 of ISO17025 covers the management of laboratory equipment, a vital function within the laboratory. Emphasising maintenance and calibration plans, an integrated LIMS enables creation, management, and enforcement of these plans. As each calibration or maintenance event is recorded, together with its outcome, a comprehensive equipment history is created. Equipment that has not been calibrated or maintained according to the required schedule can be taken out of service, as can instruments that have failed calibration or require repair. The use of such instruments can be prevented in the same way as analysts who do not have the correct certifi cation... ISO17025 requires competent operation and valid results, and a LIMS plays a key role in achieving and maintaining accreditation.
INTERNATIONAL LABMATE - JULY 2023
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