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==Conclusion== | ==Conclusion== | ||
This brief topical article sought to answer "what are the key elements of a LIMS to better comply with ISO/IEC 17025?" In particular, it examined the requirements scope of ISO/IEC 17025 within the context of a robust LIMS requirements specification like LIMSpec. As labs have increasingly turned to the LIMS as a tool for not only helping to modernize and improve the quality of the laboratory but also aid with compliance to standards like ISO/IEC 17025, LIMS vendors have had to incorporate functionality helpful to those labs' goals. We learned that the topics of quality, LIMS, and ISO/IEC 17025 intersect in different ways, emphasizing the importance of a LIMS to monitoring and acting upon any lab activities impacted by quality and the standard. But not any LIMS will do; labs can narrow down specific functionality that helps them better comply to ISO/IEC 17025. Table 1 of this article explicitly linked the requirements of ISO/IEC 17025 to specific requirements in the LIMSpec specification document, and it gave a more digestible take on how that LIMS requirement better helps the lab comply with the standard. At the end, the information from Table 1 was distilled down to a simple workflow-driven list of LIMS requirements a lab should strongly consider when examining various LIMS systems for acquisition. | |||
==References== | ==References== | ||
Revision as of 20:11, 14 January 2023
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Title: What are the key elements of a LIMS to better comply with ISO/IEC 17025?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: TBD
Introduction
While ISO/IEC 17025 provides numerous benefits to a laboratory, it still asks a lot of the laboratory in order to conform with the standard.[1] Today, conforming to ISO/IEC 17025 without the help of an information management system is a daunting task, especially given requirements concerning timely data retrieval and security. Labs have increasingly turned to a laboratory information management system (LIMS), not only for helping to modernize and improve the quality of the laboratory but also aiding with compliance to standards like ISO/IEC 17025.[2][3] However, not all LIMS are built the same, and the laboratory must consider LIMS vendors who provide a solution that best helps them limit the burden of ISO/IEC 17025 compliance.
This article will turn to LIMSpec—a laboratory informatics requirements specification document that has evolved significantly over the years—for input into what critical requirements of a LIMS are in regards to better complying with ISO/IEC 17025. With the current version of LIMSpec having at its core standards such as ASTM E1578-18 Standard Guide for Laboratory Informatics[4] and ISO/IEC 17025 Testing and calibration laboratories[5], the LIMSpec makes for a durable requirements document that, when used to acquire an informatics solution, can better help a laboratory choose appropriate functionality based upon current standards, regulations, guidance, and more.
In particular, this brief article will look at the touch points of ISO/IEC 17025 with LIMSpec and highlight their importance. But before we get into specific requirements, let's take a brief look at the connection between a laboratory informatics solution like a LIMS and managing quality in the laboratory.
LIMS and quality management
In order to be most successful—while meeting the requirements of standards and regulatory pressures—a laboratory must focus on a culture of quality.[6] A quality management system or QMS is one means for a laboratory to put additional focus on quality, and ISO/IEC 17025:2017—at least in spirit—promotes the adoption of a QMS. At issue is that while Section 8 of ISO/IEC 17025:2017 addresses the laboratory's management system, it never directly calls it a "quality management system" or QMS; in fact, the word "quality" only appears once in this section. However, the implication is that the standard is addressing quality with its requirements for a management system, i.e., a QMS[5]:
The laboratory shall establish, document, implement, and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results.
This discussion about the (quality) management system requirements of ISO/IEC 17025:2017 is important in the context of a LIMS, as related discussion of the role of a LIMS in better managing a lab's quality system has been occurring for at least several decades.[7][8] As early as 1999, the "contribution that both system design and functionality" of a LIMS can have on a lab's efforts towards "building quality" was being discussed by researchers.[7] Additionally, as Hull et al. noted in 2011, a LIMS that allows the lab to track and control anything affecting the quality of its operations is critical to successfully developing, implementing, and revising a QMS. "...there is more than just the end product or result that needs to be tracked and controlled," the authors add. "All of the intermediate products and resources play a significant role in producing the final product, and each of these needs to be included in the LIMS."[9]
Here, Hull et al.[9], as with their predecessors[7], highlights the importance of practical and consistent LIMS functionality to the efforts of maintaining quality in the lab. As such, with:
- laboratory adoption of ISO/IEC 17025:2017 increasing steadily since 2010, according to the International Laboratory Accreditation Cooperation (ILAC),[10] as a means to demonstrate "that [labs] operate competently and generate valid results"[5] (i.e., focus on quality); and
- LIMS vendors needing to improve their efforts with addressing a lab's need for tracking and controlling quality within its workflow[9]
... today's laboratories seeking to improve quality and meet ISO/IEC 17025 requirements with the help of a LIMS must be mindful of not only what ISO/IEC 17025 demands of the lab, but also what LIMS functionality is required to help the lab be more compliant.
ISO/IEC 17025 and its connection to various LIMS requirements
It's clear that a laboratory's quality goals can and should be tied to standards like ISO/IEC 17025[11], and compliance to the standard is better accomplished with the help of a laboratory informatics solution like a LIMS. However, the LIMS needs to have a bit more than generic functionality in order to best assist the lab with its goals.
What follows, in Table 1, is a demonstration of how a modern LIMS requirements specification like LIMSpec ties to the requirements of ISO/IEC 17025. In addition to listing the standard's section number and the associated LIMSpec requirement, an attempt has been made to explain in clearer terms the impact of the requirement on the lab towards better complying with ISO/IEC 17025.
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We can simplify Table 1 down to the following functionality as being important to a lab attempting to conform to ISO/IEC 17025, organized by workflow descriptors:
Test, sample and result management
- Complete capture of a registered sample's data and metadata
- Unique sample identifiers
- Free-form reception-based sample data
- Barcode and RFID support
- Preloaded and configurable sample types and analytical test methods
- Robust sampling and test method development
Quality, security, and compliance
- Multi-level review of test results
- Validation of sampling and test methods
- Support for mapping professional requirements to existing system tasks, sample types, and methods
- Instrument lock-out
- Consistent, retrievable calibration and maintenance records
- Calibration activity linkages
- Calibration and maintenance audit trail
- Nonconformance and deviation tracking
- Statistical trending and control charts
- Internal and external audit management
- Secure backup and retrieval
- Facility monitoring
- Environmental monitoring
- Data retention
- Robust system security
- LIMS validation
- Secure granular access
- Logical and physical access control
Operations management and reporting
- Document management, with versioning and release controls
- Controlled document access
- Provision of the most current document version
- User manuals and training documentation
- Support for unique document identifiers
- Support for training and certification records
- Complaint and problem management
- Unique identification of instruments
- Support for scheduled, frequency-based calibration and maintenance
- Support for data and metadata archiving
- Support for rapid and accurate retrieval of archived data and metadata
- Support for certificates of analysis or similar verification documents
- Support for changed, amended, or re-issued reports
Conclusion
This brief topical article sought to answer "what are the key elements of a LIMS to better comply with ISO/IEC 17025?" In particular, it examined the requirements scope of ISO/IEC 17025 within the context of a robust LIMS requirements specification like LIMSpec. As labs have increasingly turned to the LIMS as a tool for not only helping to modernize and improve the quality of the laboratory but also aid with compliance to standards like ISO/IEC 17025, LIMS vendors have had to incorporate functionality helpful to those labs' goals. We learned that the topics of quality, LIMS, and ISO/IEC 17025 intersect in different ways, emphasizing the importance of a LIMS to monitoring and acting upon any lab activities impacted by quality and the standard. But not any LIMS will do; labs can narrow down specific functionality that helps them better comply to ISO/IEC 17025. Table 1 of this article explicitly linked the requirements of ISO/IEC 17025 to specific requirements in the LIMSpec specification document, and it gave a more digestible take on how that LIMS requirement better helps the lab comply with the standard. At the end, the information from Table 1 was distilled down to a simple workflow-driven list of LIMS requirements a lab should strongly consider when examining various LIMS systems for acquisition.
References
- ↑ Douglas, S.E. (January 2023). "LIMS FAQ:How does ISO/IEC 17025 impact laboratories?". LIMSwiki. https://www.limswiki.org/index.php/LIMS_FAQ:How_does_ISO/IEC_17025_impact_laboratories?. Retrieved 14 January 2023.
- ↑ Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., "Laboratory Information Management Systems (LIMS)" (in en), Cannabis Laboratory Fundamentals (Cham: Springer International Publishing): 131–151, doi:10.1007/978-3-030-62716-4_7, ISBN 978-3-030-62715-7, http://link.springer.com/10.1007/978-3-030-62716-4_7. Retrieved 2023-01-14
- ↑ Apte, A. (20 October 2020). "Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?". Food Safety Tech. https://foodsafetytech.com/column/is-your-food-testing-lab-prepping-for-an-iso-iec-17025-audit/. Retrieved 14 January 2023.
- ↑ "ASTM E1578-18 Standard Guide for Laboratory Informatics". ASTM International. 23 August 2019. https://www.astm.org/e1578-18.html. Retrieved 14 January 2023.
- ↑ 5.0 5.1 5.2 "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 14 January 2023.
- ↑ Kennedy, T.M.; Kennedy, J.L.; Donaldson, R.M. et al. (2022). "A Call for Action to Maintain a Culture of Quality in the Clinical Laboratory" (PDF). Genetics & Molecular Medicine 4 (1): 1–2. doi:10.33425/2689-1077.1013. https://www.scivisionpub.com/pdfs/a-call-for-action-to-maintain-a-culture-of-quality-in-the-clinical-laboratory-2116.pdf.
- ↑ 7.0 7.1 7.2 Steele, T. W.; Laugier, Alain; Falco, François (3 March 1999). "The impact of LIMS design and functionality on laboratory quality achievements". Accreditation and Quality Assurance 4 (3): 102–106. doi:10.1007/s007690050324. ISSN 0949-1775. http://link.springer.com/10.1007/s007690050324.
- ↑ Çağındı, Özlem; Ötleş, Semih (1 December 2004). "Importance of laboratory information management systems (LIMS) software for food processing factories" (in en). Journal of Food Engineering 65 (4): 565–568. doi:10.1016/j.jfoodeng.2004.02.021. https://linkinghub.elsevier.com/retrieve/pii/S0260877404000846.
- ↑ 9.0 9.1 9.2 Hull, Carl; Wray, Bruce; Winslow, Ford; Vilicich, Mark (1 November 2011). "Tracking and Controlling Everything that Affects Quality is the Key to a Quality Management System" (in en). Combinatorial Chemistry & High Throughput Screening 14 (9): 772–780. doi:10.2174/138620711796957125. http://www.eurekaselect.com/openurl/content.php?genre=article&issn=1386-2073&volume=14&issue=9&spage=772.
- ↑ "About ILAC > Facts & Figures". ILAC. 2021. https://ilac.org/about-ilac/facts-and-figures/. Retrieved 14 January 2023.
- ↑ Douglas, S.E. (January 2023). "LIMS FAQ:What is the importance of ISO/IEC 17025 to society?". LIMSwiki. https://www.limswiki.org/index.php/LIMS_FAQ:What_is_the_importance_of_ISO/IEC_17025_to_society?. Retrieved 14 January 2023.
- ↑ Sanchez, Juan M. (11 May 2021). "Use of Control Charts and Scientific Critical Thinking in Experimental Laboratory Courses: How They Help Students to Detect and Solve Systematic Errors" (in en). Journal of Chemical Education 98 (5): 1822–1828. doi:10.1021/acs.jchemed.0c00885. ISSN 0021-9584. https://pubs.acs.org/doi/10.1021/acs.jchemed.0c00885.
- ↑ Maxwell, G. (1 November 2003). "Using Workflows in LIMS to Reduce Customization". Scientific Computing. Archived from the original on 07 August 2009. https://web.archive.org/web/20090807034051/http://www.scientificcomputing.com/using-workflows-in-lims-to-reduce.aspx. Retrieved 14 January 2023.
