LII:LIMS Selection Guide for ISO/IEC 17025 Laboratories

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

When it comes to international standards for laboratories, ISO/IEC 17025 is arguably one the most recognizable. With its focus on helping testing, calibration, and sampling laboratories to demonstrate "the competence, impartiality, and consistent operation" of their business activities, a strong focus on quality becomes apparent. Given the standard's demands, an increasing number of labs have turned to laboratory informatics solutions like the laboratory information management system (LIMS) and electronic laboratory notebook (ELN) to help not only improve laboratory workflows but also better comply with ISO/IEC 17025.

This guide introduces the topic of ISO/IEC 17025 and addresses how the standard impacts laboratories attempting to adopt and comply with it. More importantly, it examines what LIMS features are vital to helping the lab achieve its standard-based goals, with the help of the user requirements specification (URS) LIMSpec. It then addresses other important aspects of system acquisition, including tips on how to best put the URS and documents such as the request for information (RFI) to use. The guide also includes additional resources helpful to the lab seeking to comply to the ISO/IEC 17025 standard.

The table of contents for LIMS Selection Guide for ISO/IEC 17025 Laboratories is as follows:

1. Introduction to ISO/IEC 17025

1.1 History of ISO/IEC 17025

1.2 ISO/IEC 17025 vs. ISO 9001

1.3 How we benefit from ISO/IEC 17025 laboratories

2. How ISO/IEC 17025 affects and benefits laboratories

2.1 Types of labs affected by ISO/IEC 17025

2.1.1 Analytical and regulatory testing labs

2.1.1.1 Product development and manufacturing labs

2.1.2 Basic and applied research labs

2.1.3 Reference measurement and calibration labs

2.1.4 A note about clinical laboratories

2.2 What ISO/IEC 17025 asks of laboratories

2.2.1 Competence, impartiality, and consistent operations

2.2.2 Demands on the laboratory

2.2.3 Addressing gaps in ISO/IEC 17025

2.3 How laboratories benefit from ISO/IEC 17025 compliance

3. Choosing laboratory informatics software for better ISO/IEC 17025 compliance

3.1 Evaluation and selection

3.1.1 Technology considerations

3.1.1.1 Laboratory informatics options

3.1.1.2 LIMS, quality management, and the QMS

3.1.2 Features and functions for ISO/IEC 17025 compliance

3.1.3 Cybersecurity considerations

3.1.4 Regulatory compliance considerations

3.1.5 System flexibility

3.1.6 Cost considerations

3.2 Implementation

3.2.1 Internal and external integrations

3.3 MSW, updates, and other contracted services

3.4 How a user requirements specification fits into the entire process (LIMSpec)

4. Resources for selecting and implementing informatics solutions

4.1 LIMS vendors

4.2 Consultants

4.3 Other resources

4.3.1 ISO/IEC 17025 accreditation bodies

4.3.2 ISO/IEC 17025 reference and resource library

4.4 LIMSpec

5. Taking the next step

5.1 Conduct initial research into a specification document tailored to your lab's needs

5.2 Issue some of the specification as part of a request for information (RFI)

5.3 Respond to or open dialogue with vendors

5.3.1 The value of demonstrations

5.4 Finalize the requirements specification and choose a vendor

5.5 LIMSpec in Microsoft Word format

6. Closing remarks