Examples of these changes include the use of quality control samples/materials, functional checks, alternative instrumentation, use of control charts, and/or the review of reported results. Although it gives greater flexibility to these requirements, based on risk-analysis, the laboratory should have a strategy for how to confirm and monitor the validity of these test results. The new standard also includes a clearer definition of the requirements for establishing the validity of test results. In addition, any deviation from the test methodology, which may influence the result, must be reported. If laboratory developed or non‑standardised methods are to be used, they must firstly be validated via the consideration of relevant characteristics such as robustness. All the standard methods must be verified to show that the laboratory meets the performance requirements. ISO/IEC 17025:2017 has clearer definitions for method validation and verification. Table 1 summarises the main changes in the new ISO/IEC 17025 standard and outlines its impact on food laboratories and their customers. Examples of this results orientated approach include the absence of terms such as ‘quality manual’ and ‘quality manager’, the lack of a requirement to conduct annual internal audits and management reviews (instead these are performed at planned intervals), the introduction of risk-based thinking and assessments for all laboratory activities, and finally, there are options for management system requirements.įrom a technical perspective, the incorporation of decision rules for conformity assessment, giving opinions and interpretations in the results, the contribution of sampling on measurement uncertainty, and ensuring result validity, are all new topics that have considerably changed the laboratory environment. Previous iterations of ISO/IEC 17025 essentially revolved around prescriptive requirements, but the 2017 version differs because it imposes a process-based model that focuses on results, thereby giving greater flexibility to the laboratory in its operations. It is therefore important to consider both groups – laboratory and customer – when evaluating the impact of the transition. At the same time, food laboratory customers have also been affected by the new standard’s practices. The transition to ISO/IEC 17025:2017 introduced several changes to the activities and management systems employed by food testing laboratories. Many laboratories had, however, already completed the process and this gives us insight into the impact of ISO/IEC 17025:2017 on accredited laboratories and their customers in the food supply chain.Īccreditation to ISO/IEC 17025, the globally recognised standard for laboratory competence in testing and calibration, is indispensable for food testing laboratories, especially those that act as a hub for the provision of safety and quality evidence in supply chains. ILAC, in agreement with ISO, has since extended that transition period until 1 June 2021 due to COVID-19. Laboratories were originally given until 30 November 2020 to transition to ISO/IEC 17025:2017.
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