Presentation of the new EUROLAB guidance document on the management of digitalised processes in laboratories accredited to ISO/IEC 17025:2017

Digital transformation has become a key challenge for laboratories, with its share of benefits but also of risks, mainly for information security. The last version of ISO/IEC 17025:2017 puts a stronger emphasis on risk management, confidentiality and information management. Based on surveys and reported issues from laboratories across Europe, EUROLAB (the European federation of national associations of measurement, testing and analytical laboratories) identified the need for more practical guidance on how to address ISO/IEC 17025 requirements in the context of digitalised processes. This article presents the last EUROLAB guidance document on the management of digitalised processes. The goal of the guidance document is to answer two broad questions: (1) “How to meet ISO/IEC 17025:2017 requirements related to the use of digital technologies and information security ?” and (2) “How digital technologies can be used to support compliance to ISO/IEC 17025:2017 requirements in general”. This guidance extensively links ISO/IEC 17025:2017 and ISO/IEC 27001:2022, lists the most frequent risks in laboratories, suggests a risk analysis methodology called “risk-based classification” and provides practical recommendations about a total of twenty preventive and corrective actions (i.e.“controls”). Perspectives for future improvement are also identified.