ISO 17025 2017 CHANGES FROM 2005 ISO
And it does so as a way of aligning the standard with the ISO 9001:2015 quality management and cover all technical changes, technical developments, and developments in IT techniques that the industry has seen since the last version of the 2005 standard.
The introduction of computerized systems for the treatment of data and information is one of the main changes introduced by ISO/IEC 17025. H) details of any damage, malfunction, modification or repair of the equipment.Ĭoncerning Metrological Traceability, a review of the options for their demonstration and establishment is presented. G) the maintenance and maintenance plan carried out to date when it is relevant to the performance of the equipment
ISO 17025 2017 CHANGES FROM 2005 SERIAL NUMBER
The records shall include the following, when applicable:Ī) the identity of the equipment, including the software and firmware version ī) the name of the manufacturer, identification of the type and serial number or other unique identification Ĭ) evidence of verification that the equipment meets the specified requirements Į) calibration dates, calibration results, adjustments, acceptance criteria and expiration date of the next calibration or calibration interval į) documentation or reference materials, results, acceptance criteria, relevant daters and validity period Reorder the data that should be kept as activity control records:Ħ.4.13 Records of equipment that may influence laboratory activities shall be maintained. Regarding the equipment calibration status:Ħ.4.8 All equipment that requires calibration or has a defined validity period should be labeled, coded or otherwise identified to allow the user of the equipment to easily identify the status of the calibration or the period of validity. Regarding the conformity of the equipment, ISO/IEC 17025 establishes:Ħ.4.4 The laboratory will verify that the equipment complies with the specified requirements before placing it or putting it back into service.Ħ.4.5 The equipment used for the measurement must be able to achieve the accuracy of the measurement and/or the measurement uncertainty required to provide a valid result. Within the Equipment, consumables are now incorporated, especially reagents. Regarding personnel (Human Resource 6.2) and facilities and environmental conditions (6.3), no significant changes are presented.īut in Equipment (6.4), the changes introduced by ISO/IEC 17025 are significant.
Regarding the requirements on resources, and understanding that the new standard offers a flexible framework oriented towards achievement, ISO/IEC 17025 incorporates the concepts of access and availability to resources, allowing the laboratory to choose the route it considers most appropriate, always considering the level of risk you want or can take. Therefore, the changes introduced by ISO/IEC 17025 regarding Equipment and Computerized Systems, acquire special relevance, which is why we review the clauses that affect the management of the computerized environment in the laboratory. With a greater focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic reports and results. This document replaces the 2005 edition and incorporates relevant modifications on the requirements that the laboratories to generate valid results. The impartiality, competence, and confidence in the operation of the laboratories are guaranteed by the ISO/IEC 17025 standard, whose revision was published in December 2017. In this article, we analyze the changes and requirements introduces by ISO/IEC 17025:2017 regarding Equipment and Computerized Systems
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