DANSK DSF/PREN 9212 PDF

The aim of a MIF and the associated justifications is to ensure that manufacturing and/or inspection operations are realized in a compliant and reproducible manner, in accordance with the regulations in force. The purpose of this document is to provide a guide to the elaboration of the MIF and the associated justifications by: – positioning them within the framework: o of a programme and its objectives, on the one hand, o of the realization of a product, on the other; – describing, until production of the product ceases: o the principles and conditions applying to the elaboration and then the validation of the MIF within the framework of the industrialization process, o the principles and conditions applying to the elaboration and then the validation of the MIJF associated with the MIF, within the framework of the industrialization process, o the principles and change and control conditions applying to the MIF and the MIJF. This document can be used for all processes or sets of processes implemented on a tangible product, which may incorporate software associated with the product. It does not apply to purely software product, commercial-off-the-shelf product (catalogue part) or service (intangible product). This document applies more particularly to serial production. Nevertheless, the principles and conditions set forth in this document may be applied, making any necessary adaptations, to unit production or to the realization of products to meet development needs (prototypes, demonstrators, etc.). This document covers the MIF and the MIJF of a product, including the activities related to procurement and the associated industrial means in particular.