For the development of the consultancies we use a highly participatory methodology, where our client, through his staff, becomes the owner of the system to be implemented, while in SGE we fulfill our function of process facilitators. In the initial stages, the main opportunities for improvement of the organization will be evaluated, in order to develop the consultancy, taking into account the required changes.
It is necessary to integrate a team of champions from the management system, to carry out the activities programmed in the schedule such as: training, assignment of tasks and responsibilities, compliance monitoring, definition, implementation and validation of processes. In this way, the documentation generated as the first version will already have substantial improvements in the processes that will be reflected in the management and controlled from indicators generated for effective monitoring.
However, the pace of progress does not depend exclusively on SGE Consultores, but on the willingness and commitment shown by the client to fulfill the tasks and deadlines assigned for each stage of the process. We also encourage constant feedback between the parties, so that adjustments are made in a timely manner to achieve the objectives set.
ISO 13485 is an international norm, applied to organizations or companies dedicated to the design, manufacture and distribution of medical devices. Our services in this area are focused in the training and interpretation of the norm (including regulatory requirements for FDA) the preparation of inter quality auditors and the pre-audit service for the evaluation of the Quality Management System of the company against the norm requirements.
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