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How LIMS Enhances ISO/IEC 17025 Compliance

March 12, 2024
In laboratory management, implementing a Laboratory Information Management System (LIMS) has emerged as a pivotal tool for ensuring quality, efficiency, and compliance. Particularly in the context of ISO/IEC 17025, the international standard for testing and calibration laboratories, LIMS plays a crucial role in streamlining processes, maintaining data integrity, and ultimately…
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Leveraging a Sandbox LIMS for ISO 17025 Compliance

March 12, 2024
In laboratory management, ensuring compliance with stringent regulatory standards like ISO 17025 is paramount. Laboratories often turn to Laboratory Information Management Systems (LIMS) to streamline operations and meet these requirements. However, assessing the suitability of a LIMS for ISO 17025 compliance requires meticulous testing and validation, which is where a…
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What Role Does a LIMS Play in ISO 17025 Accreditation & Compliance?

February 28, 2024
At its core, ISO 17025 (ISO/IEC 17025) is all about being a registered, genuine laboratory using valid test methods that produce verifiable, accurate results and the organization and documentation of all of it. It is the general laboratory equivalent of the medical laboratory standard ISO 15189. The latest iteration, ISO/IEC…
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What standards & regulations affect a manufacturing-related lab?

February 28, 2024
By incorporating ISO 9001, ISO 17025, and FDA regulations into their operational frameworks, manufacturing-related laboratories elevate their practices to the highest quality, precision, and integrity standards. As these standards evolve, laboratories must remain vigilant, adapting and integrating new protocols to stay at the forefront of quality and compliance. Laboratories embracing…
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What types of lab testing are affected by ISO/IEC 17025?

February 28, 2024
Testing in ISO/IEC 17025 laboratories The scope section of ISO/IEC 17025 indicates that the standard “is applicable to all organizations performing laboratory activities, regardless of the number of personnel.”[1] Further, in its terms and definitions section, the standard states that a laboratory—for the purposes of the document—is a “body that performs…
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How does ISO/IEC 17025 impact laboratories?

January 29, 2024
What ISO/IEC 17025 asks of laboratories While ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories has laboratory quality control handily in mind, and it is increasingly adopted by laboratories[1], the standard is challenging to adopt, especially for small and academic labs.[2] Additionally, several regions of the world…
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What are the key LIMS elements for ISO/IEC 17025 compliance?

January 9, 2024
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.[1] A quality management system (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…
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What is the importance of ISO/IEC 17025 to society?

January 9, 2024
ISO/IEC 17025: Supporting quality management in the lab ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is an internationally recognized standard that places requirements on testing, calibration, and sampling laboratories to demonstrate “the competence, impartiality, and consistent operation” of their business activities.[1] At its core, the standard places a…
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The Power of LIMS: Achieve and Maintain ISO 17025 Accreditation

June 21, 2023
Download PDF Laboratories hold the key to unlocking the mysteries of science. But how can we ensure that laboratories consistently produce test results that are accurate and dependable? ISO /IEC1705, also known as ISO 17025, is an international standard that plays a crucial role in verifying that laboratories consistently produce…
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Harnessing Informatics for Effective Lab Inspections and Audits

June 12, 2023
Download PDF Product safety is one of the driving factors in government oversight, as applied to the consumer. Whether it is concerned with medications, food, transportation, or housing, product safety drives the development of regulations for manufacturing and production across industries. As a result, the consumer is better assured of…
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