LII:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Closing remarks
6. Closing remarks
The ISO/IEC 17025 standard is one of several standards that prescribes quality management and quality systems to entities wishing to improve their operations and have a more positive impact on their customers. In particular, ISO/IEC 17025 asks analytical, calibration, and sampling laboratories to demonstrate "competence, impartiality, and consistent operation" in its activities, enabled by a strong focus on implementing procedural and quality management mechanisms as a means towards meeting those goals. As Chapter 1 points out, laboratories are interwoven throughout our society—conducting analytical, product development, research, and reference and calibration activities—and we expect their resulting data to be timely, accurate, traceable, and secure. These expectations are represented in the ISO/IEC 17025 standard. Labs benefit in many ways from complying with the standard, as Chapter 2 notes, but not without some sacrifice. However, these labs can benefit from laboratory informatics solutions like the laboratory information management system (LIMS) and their ability to streamline workflows and provide features that make ISO/IEC 17025 compliance a less painful process.
Choosing a LIMS for ISO/IEC 17025 compliance is not necessarily a straightforward task. To be sure, researching business needs, building a list of system requirements, investigating LIMS vendors, and getting the desired LIMS implementation is a complicated process regardless of what industries your lab serves. Adding ISO/IEC 17025 compliance to your lab's needs can easily add another layer of complication to the LIMS acquisition process, but it doesn't have to. Chapter 3 helps the lab through this process and identifies critical LIMS features that allow for better compliance with the standard, with the help of a freely available requirements specification called LIMSpec. We found that the LIMS with robust sample and method development tools, iron-clad security methods (including role-based access), and support for archiving and retrieving archived data—among other functionality—is critical to the ISO/IEC 17025 lab. But there's more to consider as well, including cybersecurity, system flexibility, cost, implementation, and warranties. These complexities may be daunting for some lab managers, and Chapter 4 provides additional resources towards being more informed about those nuances. Finally, Chapter 5 walked the reader through how a requirements specification like LIMSpec, requests for information (RFIs), and system demonstrations all further help the lab make its final decisions and better ensure the lab is getting what it needs from the LIMS to better remain ISO/IEC-compliant.
All said, ISO/IEC 17025 compliance doesn't have to be as daunting a task as it sounds for the laboratory. A consistent and time-tested methodology of understanding the lab's needs, knowing the specifics of the standard, developing a requirements document, investigating LIMS vendors, and following through on a plan of action will do a lot towards meeting your lab's compliance goals. Hopefully this guide has been of use to you in that regard.
Citation information for this chapter
Chapter: 6. Closing remarks
Title: LIMS Selection Guide for ISO/IEC 17025 Laboratories
Edition: First Edition
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: February 2023