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T he term “laboratory activities” activities” has been introduced. In the new version, a laboratory has been defined as an organization that can perform testing, calibration and/or sampling associated with subsequent testing or calibration. Ī new definition of the term “laboratory” laboratory” and its activities has been included.
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The result or the purpose of certain processes is now embedded in the formulations (performance-based requirements), while the concrete design of the processes (the "how") is left up to the users consequently, the description of individual process steps has been abandoned. While in the previous edition of ISO/IEC 17025 specific provisions for the implementation in the laboratory have been expressed, the new choice of words is more performance-based and therefore much more abstract. Ī stronger process orientation and the implementation implementation of risk-based thinking t hinking are reflected in a changed way of formulating the requirements.The standard also includes two Annexes that were not included in the previous version: metrological traceability traceability ➢ Informative Annex A, related to metrological Informat ive Annex B, related to the different options of the laboratory management ➢ Informative system Structure requirements requirements Resource requirements requirements Process requirements Management system requirements The new structure of the standard is no longer based on the two main chapters (four for Management requirements, and five for Technical requirements) we were used to to be harmonized with the rest, this one follows the CASCO guidelines for conformity assessment standards, and the structure is more process oriented: ➢ ➢ ➢ ➢ General General cons iderations This new standard ISO/IEC 17025 includes some noteworthy changes related to its structure and scope that should be mentioned before we go into greater details of each section of the standard.