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This work aims to highlight the factors that characterize quality systems in the case of pressure equipment manufacturing. For the CE marking, according to the Pressure Equipment Directive (PED), the manufacturer may adopt conformity assessment modules based on the Quality System for production process, directly for the product, for its final inspection and testing or for full fabrication process, design included. At international level, the ISO 9001 standard is now consolidated and wide spread and was revised in 2015 with the introduction of new concepts. This article highlights the individual requirements of ISO 9001 which are directly and indirectly correlated with the Quality System factors required by PED. This allows to comply with the essential safety requirements of the directive following a Plan-Do-Check-Act approach and conforming to the formalization of the management systems provided by the High Level Structure.

Coronavirus disease 2019 (COVID-19) health concern and travel restrictions have significantly affected conformity assessment activities in the scope of the 2014/68/UE directive (PED). Certification Bodies can anyway introduce alternative arrangements to conduct assessments e.g. remotely by using information and communication technologies (ICT). To this end, according to the International Accreditation Forum documents a feasibility analysis is required. The analysis must demonstrate the remote assessment could assure the same effectiveness of an on-site visit, otherwise it is not allowed. The present work illustrates the result of the feasibility analysis carried out by the Notified Body (NB) INAIL 0100 and the operative instruction it is implementing in its Quality System (QS) compliant with ISO 17065 standard, to define the operating mode for each phase of the “smart” conformity assessment, the documental examination and the final product inspection and testing. The feasibility analysis was focused on the availability of ICT and the necessary infrastructure to support their use both by the NB and the manufacturer, as like as the possibility to assure security and confidentiality of electronic or electronically-transmitted information. These issues have led to the definition of minimum requirements to assure operation during the remote assessment. Another important issue faced by the NB in the analysis has been the identification of qualification criteria for determining when it is appropriate to perform an assessment remotely. Furthermore the analysis of risks and opportunities that may impact audit/assessment effectiveness for each use of ICT under the same conditions, highlighted a limited impact of the selected ICTs, with a risk level maintained on the same level of the “in presence” visits. This innovative solution has allowed to keep the NB in operation during the COVID-19 emergency while maintaining efficiency and safety, and provided also new opportunities of better timing and inclusion of personnel that may not be easily accessible.