Giacobbe, Francesco , Bemporad, Elisabetta , Pera, Fabio , CARRO PAULETE, ANDRES
No
Int. J. Qual. Res.
Article
Científica
4
2
1
01/01/2024
001221706800006
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.
CE marking; Directive PED; HLS High Level Structure; ISO 9001; 2015; pressure equipment; quality management system; risk based thinking