#Iso 17025 2017 quality manual pdf how to#
Suggestions on how to impl ement ement the novelties The objectives of risk assessments in the laboratory (8.5) are to: “a) give assurance that the management system achieves its intended results b) enhance opportunities to achieve the purpose and objectives of the laboratory c) prevent or reduce r educe undesired impacts impacts and potential failures in the t he laboratory activities and d) achieve improvement.” improvement. The laboratory is responsible for deciding which risks and opportunities need to be addressed. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management management system, achieving improved results and preventing negative effects.
Identifi Identifi cation of changes This document requires the laboratory to plan and implement actions to address risks and opportunities. RISK BASED B ASED THINKING Cross reference ISO/IEC 17025:2017 Clause Introduction In the following, this handbook identifies the major innovations of ISO/IEC 17025:2017, often in comparison to the previous version, gives suggestions on how to implement the novelties, and recommends further readings on the particular clauses, especially to the CookBooks. For the user, it is important that the appropriate requirements are applied to all three activities whenever the standard speaks of laboratory activities. The resulting new definition of the term “laboratory” makes clear that laboratory activities do not only include testing and calibration but also sampling, provided that this is in connection with a subsequent test or calibration. 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.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.
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