ISO/IEC17025:20171 is the international standard that specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It can be used by laboratory customers, accreditation bodies, and other organizations to recognize the competence of laboratories. The key element of the standard is that it requires laboratories to demonstrate that they operate competently and can generate valid results. However, the latest version of the standard (2017) does not prescriptively state how this should be done; rather it encourages a risk-based approach. This requires organizations to assess the risks associated with the provisions of the standard and to show how the identified risks have been minimized. Key to this is the management of the laboratory process, the management of laboratory resources and the management of data that exists in or is created by the laboratory.
This white paper will explore the ways in which an integrated Laboratory Information Management System (LIMS) can play a key role in achieving, maintaining, and benefiting from ISO17025 accreditation.
Managing Sample Handling and Testing Processes
In some circles, there is still an impression LIMS focus on the management of samples, tests, and results with, potentially, some workflow management functionality. However, ISO17025 contains surprisingly little on this aspect of laboratory operation. Section 7.5 (Technical records) is short; it states that technical records shall include the date they were taken, the person responsible for the recording, any calculations involved in arriving at the results and the identity of the person checking the data and results. It also goes on to say that any amendment to those technical records needs to be checked as well. All of this is basic LIMS functionality. As far as supporting ISO 17025 it is more interesting to look at other sections of the standard and how an integrated fully functional LIMS supports these.
Section 6 of ISO17025 provides considerable details on the management of laboratory resources. It states specifically that the laboratory shall have available the personnel, facilities, equipment, systems, and support services necessary to manage and perform its laboratory activities. A fully integrated LIMS has a key role in helping the laboratory meet the requirements for this as detailed in a number of the subsections to Section 6.
A.2 Personnel (Section 6.2)
Section 6.2 covers personnel and, in particular, staff competency and training. As an example of the risk-based approach, the standard stipulates that the laboratory must document competency requirements for functions that influence the results of laboratory activities. However, it does not state in exact detail what these functions are, although it does go on to state that personnel must have the competence to perform the activities they are responsible for. While staff competency and training may initially be perceived as outside the scope of LIMS, this is far from the case. An integrated LIMS will have the ability to manage staff training and competency records, including the scheduling of training and retraining activities. To take this further, however, the LIMS must be able to link these records to specific activities; preventing personnel not trained or certified in an activity or task from carrying it out. A common example is the competency to carry out specific tests or methods within the lab. The system must be able to check the competency of the user at the time that they are performing the analysis. If they do not have the required training or competency, or if it has lapsed, they will be prevented from entering results into the LIMS. The same principle can be applied to other activities such as instrument maintenance and calibration.