How to Use LIMS to Drive Compliance in Food Safety Testing

In terms of direct implications for laboratories, clauses 6 and 7 of ISO 17025:2017 are the most relevant, while others are more related to planning and management. For example, clause 6 outlines the records that must be kept related to personnel (e.g., training, competency), equipment (e.g., maintenance, calibration), and system and support services (e.g., external testing services). In clause 7, there is a focus on the selection, verification, and validation of methods, as well as requirements for handling calibration items and evaluating measurement uncertainty. Laboratories are expected to have procedures in place for monitoring all these processes. Data measurements should be recorded in a way that enables trends to be detected, and determines where practical, statistical techniques should be applied to review the results and check for any signs of processes heading out of control. Overall, meeting the requirements of ISO 17025:2017 requires performance to be measured and monitored in a way that can be easily checked, reported, and acted upon.

How LIMS Can Help Align Processes to Ensure Compliance

Keeping up with the monitoring required by ISO 17025:2017 is a big task. Thousands of data points are generated each day across an endless stream of activity, such as instrument calibration, incoming samples, equipment updates, and staff training. Harnessing digital automation via an effective LIMS is, therefore, essential to ensuring compliance with the new standards. LIMS software can automatically store data in a secure, centralized location for easy access and sharing, which ultimately supports efficiency and reduces the potential for error in manual processes and data entry.

Critically, ISO 17025:2017 standards can be built into the LIMS, making compliance the “default” action. For example, when equipment is set up within an advanced LIMS, calibration and service intervals can be defined. The system will then use this information to notify stakeholders and take instruments out of service when maintenance is required. Other types of corrective actions can also be initiated; for instance, an out-of-spec result, such as bacterial growth on a medium, may trigger an automated warning on the system and prevent the user from progressing without implementing a corrective action.

It is difficult to imagine how a busy laboratory might accurately keep track of metadata associated with the analysis of a sample without the use of digital tools that automatically keep track of all the information required for ISO 17025:2017. A modern LIMS, for example, records all data, including the time, date, person who ran the analysis, equipment used, shipment details, condition on receipt, and any preparation for testing. Any deviations from planned methods can also be recorded, a critical step for ensuring compliance.

Maintaining control of records is another important aspect of clause 7. ISO 17025:2017 audits often start by checking certificates of conformance, which are controlled documents that go through an approved life cycle within the LIMS software. Only staff with certain roles should be able to access data, and logs should advise of improper attempts at data access. Modern LIMS are available to support this level of control, using password controls, audit trails, and electronic signatures.

Benefits of an Effective LIMS

There are other benefits to using digital solutions that extend beyond supporting compliance. In general, committing to ISO 17025:2017 by implementing a LIMS is an important statement of intent that tells a customer you are committed to excellence and best practices. Additionally, using a LIMS makes for easier customer management, which will likely lead to a more streamlined and positive customer experience downstream. Modern contract testing portals support quote reviews and approvals and allow samples to be logged and labels to be printed for shipping. Having a unique and professional interface for your business is a welcome change from old systems, making it easier to review everything from invoices to results. All maintenance records can be recorded on the LIMS, removing the need for multiple log books and reducing the risk of manual errors.