Compliance and Manufacturing process of high voltage blocks Mission : Installation of the preventive maintenance of the equipment (definition of the tasks and the roles, drafting of the instructions)Update of the procedures related to maintenance for the ISS organization Introduction of documents management tool : definitions of the structure and the rules of use, training of the users. Introduction of a GMAO software, creation and management equipment database, training of the users Improvement of the DHR conformity Drafting of work instructions for the manufacturing and testing of High Voltage blocks Rising of the awareness of the operators on quality: formations, communication… Realization of audits and follow-up of the actions
Technical aspects : FDA 21CFR Part 820 & Part 11 ISO 13485 / ISO 9001 V2000 Audit / 5M |