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.

References

[1] I. Diaz, "La innovación en Cuba: un análisis de sus factores clave," Innovar, vol. 29, no.71, pp. 43-54, marzo, 2019. DOI: https://doi.org/10.15446/innovar.v29n71.76394

[2] Naciones Unidas, "Transformar nuestro mundo: la Agenda 2030 para el desarrollo sostenible," A/RES/70/1 Resolución 70/1, Asamblea General, 25 de septiembre de 2015. [Online]. Available: https://undocs.org/pdf?symbol=es/A/RES/70/212

[3] M. Díaz-Canel, R. Alarcón, y J. R. Saborido, "Potencial humano, innovación y desarrollo en la planificación estratégica de la educación superior cubana 2012-2020," Revista Cubana de Educación Superior, vol. 39, n. 3, septiembre-diciembre, 2020. [Online]. Available: http://www.rces.uh.cu/index.php/RCES/article/view/383

[4] G. Ramos Castro, and A. Hernández Nariño, "Sistema de Gestión de la Calidad en un departamento de Ciencia e Innovación de una universidad médica cubana," Recus, vol. 5, no.3, pp. 76-82, September-December, 2020. [Online]. DOI: https://doi.org/10.33936/recus.v5i3.2343

[5] F. Utrilla, "Estándares e I+D+i, un binomio perfecto para conseguir los ODS," UNE La Revista de la Normalización Española, 17, septiembre, 2019. [Online]. Available: https://revista.une.org/17/estandares-e-idi-un-binomio-perfecto-para-conseguir-los-ods.html

[6] I. Ayala Ávila, "La normalización apoyando la innovación en Cuba," NC Le actualiza, no.2, pp. 1-7, julio, 2020, [Online]. Available: http://www.cgdc.cu/sites/default/files/publicaciones/nc-le-actualiza-no-2-2020.pdf

[7] M. Mir, M. Casadesús, and L. H. Petnji, "The impact of standardized innovation management systems on innovation capability and business performance: An empirical study," Journal of Engineering and Technology Management, vol. 41, pp. 26-44, July-September, 2016. DOI: https://doi.org/10.1016/j.jengtecman.2016.06.002

[8] Gestión de la I+D+i: Requisitos del sistema de gestión de la I+D+i, UNE 166002:2014, Asociación Española de Normalización y Certificación. Madrid, 2014.

[9] A. De Casanove, L. Morel, and S. Negny, ISO 50500 series innovation management: overview and potential usages in organizations, 2017. [Online]. Available: https://hal.univ-lorraine.fr/hal-01624970

[10] H, Ozan, Standardizing innovation management with ISO, 2017. [Online]. Available: http://hakanozan.net/2017/standardizing-innovation-management-with-iso/2017

[11] Gestión de la I+D+i: Terminología y definiciones de las actividades de I+D+i, NC 1306:2019, Oficina Nacional de Normalización, La Habana, 2019.

[12] Gestión de la I+D+i: Requisitos del sistema de I+D+i, NC 1307:2019, Oficina Nacional de Normalización, La Habana, 2019.

[13] Gestión de la I+D+i: Sistema de vigilancia e inteligencia, NC 1308:2019, Oficina Nacional de Normalización, La Habana, 2019.

[14] C. F. Poltronieri, M. C. Gerolamo, and L. C. Carpinetti, "An instrument for the assessment of management systems integration," Gestão Produção São Carlos, vol. 24, no. 4, pp. 638-652. DOI: https://doi.org/10.1590/0104-530x1697-14

[15] S. Talapatra; G. Santos; K. Uddin, and F. Carvalho, "International Main benefits of integrated management systems through literature review," Journal for Quality Research, vol. 13, no. 4, pp. 1037-1054, December, 2019. DOI: https://doi.org/10.24874/IJQR13.04-19

[16] R. M. Guerra Bretaña, and M. C. Meizoso Valdés, "Gestión de la calidad. Conceptos, principios, modelos y herramientas," 2nd ed., La Habana: Editorial UH, 2019.

[17] M. C. Meizoso Valdés, and R. M. Guerra Bretaña, "Implantación de Sistemas Integrados de gestión. Un reto a la empresa cubana," Normalización, no. 1, pp. 33-42, 2019.

[18] J. R. Ramírez García, and R. M. Guerra Bretaña, "La Gestión de la I+D+I: Una decisión estratégica," EKOtemas, vol. 3, no. 3, pp. 25-30, septiembre-diciembre, 2017.

[19] R. M. Guerra Bretaña, and J. R. Ramírez García, "Empresa: ¿innovación y calidad o innovación vs calidad?," In R. Torres Pérez, and D. Echevarría León, Miradas a la economía cubana. Un acercamiento a la «actualización» seis años después, La Habana, Cuba: Ruth Editorial, 2017, pp. 95-104.

[20] A. Hernandez-Vivanco A., M. Bernardo, and C. Cruz-Cásarez, (2016),"Relating open innovation, innovation and management systems integration", Industrial Management & Data Systems, vol. 116, no. 8, pp. 1540-1556, DOI: https://doi.org/10.1108/IMDS-09-2015-0405

[21] B. Manders, H. J. de Vries, and K Blind, "ISO 9001 and product innovation: A literature review and research framework," Technovation, vol 48-49, pp 41-55, February-March 2016. DOI: https://doi.org/10.1016/j.technovation.2015.11.004

[22] R. M. Guerra Bretaña, D. M. Montoya Quintero, and J. R. Ramírez García, "El enfoque de la gestión de la calidad basado en la gestión del conocimiento y de la innovación," In Ciencias económicas y contables desafíos y retos para la competitividad, Medellín, Colombia: Sello Editorial Coruniamericana, 2020, pp. 66-85.

[23] L. K. H. Lai, "Integration of Quality and Innovation Management System for Organization Innovation," Proceedings of the 13th ANQ Congress, Taipei, Taiwan, September 23-24, 2015.

[24] D. Maier, I. Sven-Joachim, A. Fortmüller, and A. Maier, "Development and Operationalization of a Model of Innovation Management System as Part of an Integrated Quality-Environment-Safety System," The Amfiteatru Economic Journal, vol. 19, no. 44, pp. 302-314, February, 2017. [Online]. Available: https://www.amfiteatrueconomic.ro/temp/Journal_no_44.pdf

[25] L. F. Á Becerra, O. A. M. Andrade, and G. L. I. Díaz, "Sistema de gestión de la calidad para el proceso de investigación: Universidad de Otavalo, Ecuador," Revista Actualidades investigativas en educación, vol. 19, no. 1, pp. 1-32. DOI: https://doi.org/10.15517/aie.v19i1.35235

[26] R. M. Guerra Bretaña, and M. C. Meizoso Valdés, "Calidad, innovación y mejora continua. Análisis de caso de innovación organizacional," Revista Cubana de Educación Superior, 2010-2011, pp.174-190, 2013.

[27] R. M. Guerra Bretaña, M. B. Valencia Bonilla, N. Martínez Alfonso, "La innovación y la gestión de la calidad universitaria, sus vínculos con la mejora del desempeño y el impacto social," 11no Congreso Internacional de Educación Superior U'2018, La Habana, Cuba, 2018.

[28] R. M. Guerra Bretaña. J. R. Ramírez García, F. J. Ramos Azcuy. Relaciones entre la gestión de la calidad, el conocimiento y la innovación," 12vo Congreso Internacional de Educación Superior U'2020, La Habana, Cuba, 2020.

[29] R. M. Guerra Bretaña, "Ciencia, innovación tecnológica y sociedad: experiencias del Centro de Biomateriales," Universidad de La Habana, no. 271, pp. 34-55, 2010.

[30] R. M. Guerra Bretaña, and Y. Veranes Pantoja, "La gestión de la innovación en el Centro de Biomateriales de la Universidad de La Habana," II Convención Internacional de Calidad "Habana 2019", La Habana, Cuba, 2019.

[31] Sistemas de gestión de la calidad. Requisitos, NC-ISO 9001:2015, Oficina Nacional de Normalización, La Habana, Cuba, 2015.

[32] R. M. Guerra Bretaña, "Normalización, calidad y gestión de riesgos en el campo de los dispositivos médicos: metodologías y estudio de casos", La Habana, Cuba, Editorial UH, 2019.

[33] Equipos Médicos. Sistemas de gestión de la calidad. Requisitos para propósitos reglamentarios, NC-ISO 13485:2018, Oficina Nacional de Normalización, La Habana, Cuba, 2018.

[34] Biomat, Manual de Gestión, Ed. 9, Mod. 01, La Habana, Cuba, marzo, 2021.

[35] Biomat, Procedimiento del Sistema PS 08 Estrategia del diseño y desarrollo, Ed. 5, La Habana, Cuba, julio, 2019.

[36] R. M. Guerra Bretaña, and A. L. Flórez Rendón, "Impact of regulations on innovation in the field of medical devices," Research on Biomedical Engineering, vol. 34, no. 4, pp. 356-367, October-December, 2018. DOI: https://doi.org/10.1590/2446-4740.180054

[37] Innovation Counsellors LLC, A Future at Risk: Economic Performance, Entrepreneurship, and Venture Capital in the U.S. Medical Technology Sector, Minneapolis, Minnesota, 2016. [Online]. Available: https://www.medtechcorekpi.org.nz/edit/library/docs/Advamed2016Afutureatrisk.pdf

[38] A. Mardani, S. Nikoosokhan, M. Moradi, and M. Doustar, "The Relationship Between Knowledge Management and Innovation Performance," Journal of High Technology Management Research, vol. 29, pp. 12-26. DOI: https://doi.org/10.1016/j.hitech.2018.04.002

[39] A. M. Acosta Soto, R. M. Guerra Bretaña, J. R. Ramírez García, "La gestión integral de los riesgos en el Centro de Biomateriales de la Universidad de La Habana," Revista Caribeña de Ciencias Sociales, June, 2018. [Online]. Available: https://www.eumed.net/rev/caribe/2018/06/gestion-integral-riesgos.html

[40] Knowledge management systems - Requirements, ISO 30401:2018, International Organization for Standardization, Genève, 2018.

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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