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Abstract
Quality management and innovation are priority issues in research facilities that close the cycle from research to products delivery for its social use. The objective of this work is to diagnose the conditions for the implementation of the Integrated Quality and Innovation Management System in the Biomaterials Center of the University of Havana, based on the standards: NC-ISO 9001:2015; NC-ISO 13485:2018 and NC 1307:2019. To do this, the stages to manage the change were established, and a diagnostic tool based on the integration of the mentioned standards was designed and applied. As a result, it was identified the need to strengthen the aspects related to: the strategies for achieving the vision, the management of ideas, the execution of projects by product, the transfer of results, the monitoring and measurement of the management of research, development and innovation activities and their results. In addition, the existing documents in the Center's management system must be modified in order to detail the implementation and monitoring of innovation activities. The integrated management, of the regulatory requirements for biomaterials, and the quality and innovation management, constitutes an organizational innovation that will facilitate the development of innovative products for the National Health System, contributing to the achievement of the organization's vision and the fulfillment of strategic objectives.
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