Diagnosis for integration of quality and innovation management systems in a biomaterials research center


Authors

DOI:

https://doi.org/10.22517/23447214.24786

Keywords:

biomaterials, quality, innovation, integrated management system

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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Author Biographies

Rosa Mayelin Guerra Bretaña, Universidad de La Habana

Rosa Mayelin Guerra Bretaña was born in Havana, Cuba in 1957. She received degree in Physics from the State University of San Petersburg, Russia in 1982, and the doctorate degree in Chemistry in 1991 at de National Centre from Scientific Research in Cuba. Since 1991 she works at de Centre of Biomaterials of the Havana University. In 1997 Dr. Guerra received the scientific category of Titular Researcher. In 2018 she received the teaching category Titular Professor. Currently, her research interests include quality management, innovation management, metrology, normalization and integrated management systems.

Maelys Hernández Almaguer , Institute of Pharmacy and Food of the Havana University, Cuba

Maelys Hernández Almaguer was born in Havana, Cuba, on August 4, 1986. She graduated in pharmaceutical sciences in 2009 from the Faculty of Pharmacy and Food of the University of Havana. From 2009 to 2019 she was a researcher at the Quality Management Department of the AIDS Research Laboratory (LISIDA). In 2016 she obtained a degree of Magister in Quality and Environmental Management at the University of Havana. Since 2020, she is a professor at the Institute of Pharmacy and Food at the University of Havana.

María Beatriz Valencia Bonilla , Universidad Tecnológica de Pereira

María Beatriz Valencia Bonilla was born on May 17, 1969 in Pereira, Risaralda (Colombia). Doctor in Economic Sciences - University of Havana (2019), Master in Economic and Financial Administration - Technological University of Pereira (2001), Bachelor of Technical Areas - Technological University of Pereira (1998), Industrial Technologist - Technological University of Pereira (1993). Associate Professor and researcher at the Technological University of Pereira, Faculty of Technology, attached to the Industrial Technology Program from May 1996 to date, also works as a professor and researcher at the Cooperative University of Colombia, Faculty of Economic, Administrative and Accounting Sciences, attached to the Business Administration Program from February 2016 to June 2020.  She has an extensive professional work and teaching experience in the accounting and financial field. Member of the Scientific Council of the IV – V - VI International Congress Knowledge Management for Sustainable Development CIGECYT. Ecuador, 2020 – 2022 – 2023. Junior researcher and peerevaluator recognized by Minciencias, 2002 and 2023. Consultant and advisor in business training programs.

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Published

2023-12-15

How to Cite

Guerra Bretaña, R. M., Hernández Almaguer , M. ., & Valencia Bonilla , M. B. . (2023). Diagnosis for integration of quality and innovation management systems in a biomaterials research center . Scientia Et Technica, 28(04), 182–190. https://doi.org/10.22517/23447214.24786

Issue

Vol. 28 No. 04 (2023): Octubre-Diciembre

Section

Industrial

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