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Scientia et Technica Año XXVIII, Vol. 28, No. 04, octubre-diciembre de 2023. Universidad Tecnológica de Pereira. ISSN 0122-1701 y ISSN-e: 2344-7214
182
Diagnosis for integration of quality and innovation
management systems in a biomaterials research center
Integración de los sistemas de gestión de la calidad y la innovación en un centro de
investigación en biomateriales
R. M. Guerra-Bretaña ; M. Hernández-Almaguer ; M. B. Valencia-Bonilla
DOI: https://doi.org/10.22517/23447214.24786
Scientific and technological research paper
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.
Index Terms biomaterials; innovation; integrated
management system, quality; research facilities.
Resumen La gestión de la calidad y la innovación son temas
prioritarios en las instituciones que cierran el ciclo desde la
investigación hasta la entrega de productos para su uso social. El
objetivo de este trabajo es diagnosticar las condiciones para la
implantación de un Sistema Integrado de Gestión de Calidad e
Innovación en el Centro de Biomateriales de la Universidad de La
Habana, basado en las normas: NC-ISO 9001:2015; NC-ISO
13485:2018 y NC 1307:2019. Para ello, se establecieron las etapas
para gestionar el cambio, se diseñó y aplicó un instrumento de
diagnóstico basado en las normas objeto de integración. Como
resultado, se identificó la necesidad de fortalecer los aspectos
relacionados con: las estrategias para el logro de la visión, la
gestión de ideas, la ejecución de los proyectos por producto, la
This manuscript was submitted on June 28, 2021, accepted on September
12, 2022 and published on December 15, 2023. This work was supported by the
Biomaterials Center of the University of Havana.
Rosa Mayelín Guerra Bretaña is a Ph.D in Chemistry and titular professor
and researcher at the Quality, Metrology and Normalization Chair and Centre
of Biomaterials of the Havana University, Cuba (e-mail:
mayelin@biomat.uh.cu).
transferencia de los resultados, el seguimiento y medición de la
gestión de las actividades de investigación, desarrollo e innovación
y sus resultados. Además, se deberán modificar los documentos
existentes en el sistema de gestión del Centro con vistas a detallar
la realización y el seguimiento a las actividades de innovación. El
manejo integrado de los requisitos regulatorios de los
biomateriales, de gestión de la calidad y la innovación constituye
una innovación organizacional que facilitará el desarrollo de
productos innovadores para el Sistema Nacional de Salud,
contribuyendo al logro de la visión de la organización y al
cumplimiento de sus objetivos estratégicos.
Palabras claves— biomateriales, calidad, innovación,
instalaciones para la investigación, sistema integrado de gestión.
I.
INTRODUCTION
HE international practice has shown that innovation is
essential for the development of a country, and companies
and other institutions of society need to be in constant
transformation, through radical or incremental innovations, to
maintain their competitiveness and achieve sustainable success.
This is possible if there is a willingness to innovate, incentives
to stimulate it, and an appropriate culture to drive it [1].
In Cuba, innovation processes are promoted from State policies
to comply with the National Plan for Economic and Social
Development (NPESD) until 2030, aligned with the Sustainable
Development Goals (SDG) of the 2030 Agenda [2]. While the
SDG are comprehensive in nature and innovation impacts all of
them, SDG 9 “Build resilient infrastructure, promote inclusive
and sustainable industrialization and foster innovation” makes
a direct reference to this activity.
The guidelines to change and the transformation process of
Higher Education in Cuba, aligned with the NPESD, are aimed
at strengthening the contributions of universities to the National
Science, Technology and Innovation System. In this way, the
dissemination and application of the scientific research results
Maelys Hernández Almaguer is Magister in Quality and Environmental
Management, professor at the Institute of Pharmacy and Food of the Havana
University, Cuba (e-mail: maelysha86@gmail.com).
María Beatriz Valencia Bonilla is a PhD in Economics of The Havana
University of Cuba and full-time professor at the Industrial Department,
Engineering Faculty of Universidad Tecnológica de Pereira, Colombia (e-mail:
mabeva@utp.edu.co).
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and the introduction of new management and administration
methods aim at making universities an important engine of
development [3] and, within them, their research centers. In this
context, the improvement of the science and innovation
management process is a highly relevant and topical research
problem in Cuban universities, with a view to achieve superior
performances [4], for which the proven quality improvement
methodologies are very useful.
It is widely recognized that standards help in making research
and development results easier to reach the market [5]. In
addition, they provide good practice and guidance for all types
of organizations trying to systematically manage innovation
[6]. Specifically, management system standards are aimed at
reducing risks to achieve organizational success and
sustainability. Research, Development and Innovation
(R&D&I) activities are also subjected to the risk management,
since during the development of the project the state of the art
and other factors of the context can be modified and, therefore,
generate unforeseen consequences, that alter its planned
execution. To manage these risks and achieve success in
planned innovations, R&D&I management system standards
are very useful.
Among the innovation management models internationally
recognized, is the R&D&I management system [7], updated in
2014 in the UNE 166002:2014 standard [8]. The standards of
the UNE 166000 series were adopted and used in several
countries and served as the basis for the preparation of the
European normative documents of the CEN/TS 16555 series.
Based on the Spanish and European experiences, the Technical
Committee ISO/TC 279 of the International Organization for
Standardization (ISO) is working on the standards series ISO
56000 for innovation management [9], [10].
Until June 2021, ISO/TC 279 has published five normative
documents:
-
ISO 56000:2020 Innovation management. Fundamentals
and vocabulary.
-
ISO 56002:2019 Innovation Management. Innovation
management system. Guidance.
-
ISO 56003:2019 Innovation management. Tools and
methods for the innovation partnership. Guidance.
-
ISO/TR 56004:2019 Innovation Management
Assessment. Guidance.
-
ISO 56005:2020 Innovation management. Tools and
methods for intellectual property management. Guidance.
Other normative documents in preparation are:
-
ISO/AWI 56001 Innovation management. Innovation
management system. Requirements.
-
ISO/FDIS 56006 Innovation management. Tools and
methods for strategic intelligence management. Guidance.
-
ISO/AWI 56007 Innovation management. Tools and
methods for idea management. Guidance.
-
ISO/AWI 56008 Innovation management. Tools and
methods for innovation operation measurements.
Guidance.
-
ISO/DTS 56010 Innovation management. Illustrative
examples of ISO 56000.
In addition, ISO/TC 279 works on two documents to
facilitate the understanding of the vocabulary that is used in the
ISO 56000 family of standards and the implementation of
innovation management systems (IMS) in organizations. These
documents are:
-
Handbook: Innovation Management. A systemic
approach to deploy an innovation management system in
your organization.
-
ISO/TS Innovation management. Layman’s Guide to
Innovation.
The Handbook is intended to guide organizations starting out
in these processes on how to implement an IMS based on
international best practices. It follows the structure and content
of the ISO 56002 standard, giving guidelines for its application.
On the other hand, the Layman’s Guide to Innovation will
provide descriptions, explanations and examples related to the
terms and definitions used in the ISO 56000 standards.
In accordance with international trends, the Cuban Technical
Committee for Standardization NC/CTN 128 Innovation
Management [6] has been established, and in its first works it
has approved the standards:
-
NC 1306:2019 R&D&I management: Terminology and
definitions of R&D&I activities. (Adoption of the UNE
166000: 2006 standard) [11].
-
NC 1307:2019 R&D&I management: R&D&I system
requirements. (Adoption of the UNE 166002: 2014
standard) [12].
-
NC 1308:2019 R&D&I Management: Monitoring and
intelligence system. (Adoption of the UNE 166006: 2018
standard) [13].
-
Until the approval of these standards, many Cuban
organizations had used the Spanish R&D&I management
system standards, in the absence of a national document. The
process of analysis and identical adoption of the Spanish
standards as Cuban standards responds to the interest of having
a certifiable IMS standard, since the published international
standard, ISO 56002, is a guidance for IMS, without the
certification purpose.
Innovation management is the part of the general
management system of the organization in charge of
developing, implementing, carrying out, reviewing and
updating the organization R&D&I policy, establishing the
R&D&I objectives and the necessary processes to fulfill them,
the identification of the necessary organizational structure and
the planning of activities, responsibilities, practices, procedures
and the human, material and financial resources required, their
adequate execution, evaluation and improvement.
It is important that the innovation activities management is
integrated in a coherent way with the rest of the existing
systems in organizations. It is recognized that the integrated
management of systems generates multiple benefits to
organizations, such as: improvement in decision-making,
reduction of the risk of redundancies and conflicts between
activities, and greater efficiency from better use of resources to
Scientia et Technica Año XXVIII, Vol. 28, No. 04, octubre-diciembre de 2023. Universidad Tecnológica de Pereira
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improve the satisfaction of all the interested parties [14], [15].
In this sense, not only technological innovations are of vital
importance, but also organizational innovations in processes
and forms of management.
Integrated management systems arise from the
implementation of two or more management standards and
were originated when the organizations perceived the
convenience of integrating quality management systems, ISO
9001, with environmental management standard, which saw the
light for the first time in the British standard BS 7750:92 and
subsequently in the European Eco-Management and Audit
Scheme (EMAS), published in 1993 and put into effect in 1995.
The publication of the first ISO standard for environmental
management ISO 14001 in 1996 consolidated the trend towards
systems integration, a process to which occupational health and
safety standards (OHSAS 18001 and ISO 45001) and other
standardized management systems were also incorporated. The
publication by ISO in 2012 of Annex SL has contributed to
facilitate the management systems integration process for both
implementation and audits [16].
The integration of systems is not a spontaneous process,
instead due to its complexity it must be adequately planned and
managed as a profound process of change in the organization,
which requires modifying the organizational culture, and the
way of thinking and acting of workers and managers [17], [18].
Everyone must understand the needs and expectations of all
relevant stakeholders and the necessity to respond to them in a
balanced way, without affecting their satisfaction when making
managerial decisions. The logic of integration starts from the
assumption that the processes constitute the basis of the
management system and that all its requirements are reflected
in them. That is why, for the success of the integration, the
barriers between the functions must be eliminated and the
process approach must be incorporated as the basic structure,
which enables the fulfillment of the integrated system
objectives, with its multiple inputs, outputs and interrelations
[16].
Although there is no simple or unambiguous relationship
between innovation and quality management, the negative or
positive influence that quality management has on innovation
depends on the way in which quality is approached, from a
control perspective or based on organizational learning. Several
authors [19] - [22] have evidenced the synergies between
quality and innovation and others [23], [24] have discussed the
integration between ISO 9001 quality management systems and
innovation management systems.
Although there has been works on the quality management
of the science and innovation processes at the universities [4],
[25], in the literature consulted, there are few studies that jointly
analyze quality management and innovation at the universities
and, specifically, in their research centers [26] - [28], neither
experiences in integrated quality and innovation management
systems in university research centers have been documented.
On the other hand, there are no previous studies regarding the
integration of the quality management system for medical
devices for regulatory purposes with R&D&I management.
The Biomaterials research facility (BIOMAT) of the
University of Havana has a more than 30 years of research
history, development and innovation for the health sector [27],
[29], [30], and has gone through several stages in its innovative
path, in order to achieve safe and effective medical products.
For this, BIOMAT has a certified quality management system
since 1991, which has passed through the different applicable
standards, up to the current NC-ISO 9001:2015 [31]. In
addition, to comply with existing regulations in the medical
device sector [32], the Center has implemented the NC-ISO
13485:2018 standard [33].
Despite the results achieved, with several products
(Tisuacryl®, Apafill-G® and Biograft-G ®) introduced in the
services of Dentistry and Maxillofacial Surgery in the country,
BIOMAT needs to enhance the innovation management to
achieve greater impacts of its science results. To contribute to
this goal, the international and national standards referring to
innovation management systems in companies and other
organizations are very useful. Based on these considerations,
the objective of this work is to diagnose the conditions for the
implementation of the Quality and Innovation Integrated
Management System (QIIMS) 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.
In the first part, the Biomaterials Center is characterized;
later the methodology for the implementation of the QIIMS is
presented. Then the common requirements and the
particularities of the three systems that are the object of the
integration are established, from which an instrument is
designed and the diagnosis is made as the basis of the action
plan to be executed for the success of the integration.
II.
CHARACTERIZATION OF THE BIOMATERIALS CENTER
The creation of the Biomaterials Center originates from the
Department of Chemistry-Physics of the Faculty of Chemistry
in 1984, when a group of researchers focused on the study of
materials to be used in medicine and dentistry. With the
development of this topic and initial funding granted by the
State Council, the Laboratory of Synthetic Materials was
created in 1990, in its initial phase as part of the Faculty of
Chemistry, and later approved as a Research Unit-
Development of the University of Havana by the Academy of
Sciences of Cuba. In 1994 it received its current name, more
appropriate to the mission of the Center and in 2005 the
Ministry of Science, Technology and Environment awarded
BIOMAT the category of Research Center [34].
The investigative activity ranges from the search for
solutions to the theoretical problems in Biomaterial Sciences,
to obtaining marketable products, through applied research and
development. Biomaterials comprise any natural, synthetic or
modified natural material that is in contact and interacts with a
biological medium, forming a medical device that treats,
augments and/or replaces any tissue or function of the body, by
itself or in a set formed by various elements [32]. Research
areas include: biomaterials for tissue replacement, restoration
and regeneration and tissue engineering, controlled release
systems for bioactive agents, materials for diagnosis,
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purification and immobilization of biomolecules.
BIOMAT staff has competence in the development of
biomaterials and in conducting their chemical and physical
evaluation. The Center's staff has 46 employees, of which 25
are researchers, five are graduates in training and eight are
technicians. Eleven researchers are PhDs in chemical, physical
or technical sciences, four are working towards PhDs, five are
Masters of Science, and four are in these studies. In addition,
relationships have been established with clinical and hospital
institutions in Havana, and other provinces of the country,
which collaborate in the preclinical and clinical evaluation of
the developed products.
So far, the innovation strategy at BIOMAT focuses on the
realization of small productions, which have managed to satisfy
the demands of the Ministry of Public Health, as the main client.
However, at the current stage this strategy has faced limitations
in material and financial resources to achieve the planned
objectives [30].
Until 2019, the following products had been produced and
marketed: Tisuacryl® (Tissue Adhesive), Apafill-G®
(hydroxyapatite granules for bone filling) and Biograft-G®
(dense β-tricalcium phosphate granules for bone filling). In
different stages of development, but with projects halted due to
lack of funding are: Multilatex® (Polystyrene latex, base for
diagnostic reagents); Bonacryl® (acrylic bone cement);
Obtudent-FC® (light-cured dental sealant) and Cubridem-FC®
(light-cured dental sealant).
The years 2020 and 2021 have been characterized by the
suspension of face-to-face activities due to COVID-19 and the
prioritization of the country's resources towards medical care,
action protocols for confronting the pandemic and the
development of vaccines and lung ventilators to do it. This
situation has slow down the research, development and
manufacture of the Center's products, which are not related to
the therapeutic schemes associated to COVID-19. However,
based on the massive vaccination of the population, which
should culminate in the third quarter of 2021, it is expected to
resume activities in the country, for which BIOMAT requires
new R&D&I strategies and to strengthen the management of
the innovation.
Currently, the BIOMAT Management System integrates the
requirements of the NC-ISO 9001:2015 standard and the
elements of the Strategic Planning and Internal Control of the
University of Havana. It also includes the regulatory aspects
established in the field of medical equipment according to the
NC-ISO 13485:2018 standard, elements of the NC-ISO
14001:2015 Environmental Management Systems and NC-ISO
45001:2018 Occupational Health and Safety Systems.
R&D&I is governed by the legislation in force in the country
for the research projects development and applies the elements
of the relevant standards to the design and development of
products, even when these aspects are only applied to projects
by products, conceptualized as technological innovation
projects for the design and development of products,
biomaterials and other processed materials, with a view to their
production and marketing [35].
BIOMAT managers have identified the processes that
influence the satisfaction of internal and external stakeholders
and have determined the sequence and interaction between
these processes. They are:
-
Strategic processes: Strategic and Operational
Management; Management of Material and Financial
Resources; Management of Human Resources;
Performance Evaluation and Improvement.
-
Key processes: Undergraduate and Postgraduate
Teaching; Research and Product Development; Transfer
of Research Results.
-
Support processes: Computerization; Material Assurance
Two of the key processes (Research and Product
Development and Transfer of Research Results) are responsible
for managing and executing R&D&I activities.
The Management Manual [32] describes the process
structure, the scope of the Management System and makes
reference to the System Procedures (PS) and the Standard
Operating Procedures (SOP), which constitute the basic
documented information for the implementation. of the
processes and the performance of the control activities, based
on the commitment of the Management, which is reflected in
the Policy and the Objectives of the Center. In addition, the
documented information includes: Technical Instructions;
Product Master Files, Master Records for production activities;
Product specifications (raw materials, intermediate products,
final products and other inputs for production); Records; and
other documents necessary to maintain and evidence the
operation of the Management System.
III.
METHODOLOGY FOR THE IMPLEMENTATION OF THE QIIMS
There is an extensive literature on systems integration studies
conducted in different organizations. Also, specifications,
guides and other normative documents have been developed to
assist organizations in the process of integrating their
management systems. Among these documents are the publicly
available British Specification BS PAS 99:2012 and the
Spanish standard UNE 66177:2005. Both documents are based
on the Deming cycle PDCA (Plan, Do, Check and Act),
however they have different approaches. The UNE 66177:2005
refers to the application of the PDCA cycle to the management
systems integration process, while the PAS 99:2012
specification combines it with the common requirements to
obtain the structural diagram of the integrated management
system [16]. Both PAS 99 and UNE 66177 can be used by
organizations when addressing the process of management
systems integration, since two aspects must be taken into
account:
-
The instrument to harmonize the common and specific
requirements of the standards to be integrated.
-
A methodology to manage the change process.
The integration process must be approached with a defined
methodology, which allows facing each stage in a planned
manner and taking into account the results of the previous
stages, starting from precisely knowing the initial situation and
the goals you want to reach. That is why a four-stage
management systems integration methodology is established:
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Stage I Context analysis
-
Analysis of regulations, applicable standards and the
needs of the organization.
-
Definition of the scope and level of integration.
-
Diagnosis of the initial situation.
Stage II Planning
-
Planning of the integration process: schedule, resources
and people in charge.
-
Definition of the necessary documentation for the
integrated management of the systems.
Stage III Implementation
-
Development and implementation of the system:
execution of scheduled activities, monitoring and control
of possible deviations.
-
Training and dissemination. Activities to be carried out at
different times of the project in order to publicize the
integrated system and communicate the modifications that
it entails in the usual work procedures.
Stage IV Maintenance and improvement
-
Audit, review and improvement of the integrated system.
-
Management system certification (if applicable).
In this work Stage I of this methodology is approached. In
the introduction made and in the characterization of the
Biomaterials Center, the first two aspects of this stage were
addressed, giving way to the initial diagnosis, as the starting
point of the required change process.
IV.
DIAGNOSIS FOR THE IMPLEMENTATION OF THE QIIMS
To carry out the diagnosis, the identification of the common
and specific requirements of the standards NC-ISO 9001:2015,
NC-ISO 13485:2018 and NC 1307:2019 was the point of
departure.
Table I reflects the standards requirements, taking as a
starting point the generic standard NC-ISO 9001 and making
reference to the sections numbered by one and two digits,
except for the items that require greater specificity because they
are more developed in some of the standards. This is the case of
NC-ISO 9001 requirement 7.1.6 Knowledge of the
organization, which is more widely deployed in NC 1307,
including essential aspects for the management of R & D & I
such as:
-
7.7 Intellectual and industrial property and knowledge
management.
-
7.8 Collaboration.
-
7.9 Technological surveillance and competitive
intelligence.
-
8.2 Idea management.
Although NC-ISO 9001:2015 and NC 1307:2019 standards
maintain the high-level structure implemented in the ISO
Directives of 2012, the NC-ISO 13485:2018 follows the
structure of the previous standard NC-ISO 9001:2008 to
facilitate its alignment with regulatory requirements,
appropriate for quality management systems in organizations
involved in one or more stages of the medical devices life cycle.
NC-ISO 13485:2018 does not have the strategic focus of the
other two standards to be integrated, but is aimed at
demonstrating the organization's ability to provide medical
devices and related services that consistently meet customer
requirements and applicable regulations. In addition, it is
focused less on business performance and improvement and
more on managing the risks of medical devices.
TABLE I
REQUIREMENTS OF THE STANDARDS OBJECT OF INTEGRATION
NC-ISO 9001:2015
NC-ISO
13485:2018
NC 1307:2019
4
Context of the organization.
4
4; 7.9
4.4
Management system and its
processes
4.1
4.3
5
Leadership
5.1-5.5;
5; 7.1
6
Planning
5.4; 8.5.4
6
7
Support
6
7
7.1
Resources
6
7.2
7.1.
6
Organization knowledge
6.2
7.7;7.8;7.9;8.2
7.2
Competence
6.2
7.3
7.3
Awareness
6.2
7.4
7.4
Communication
5.5.3
7.5
7.5
Documented information
4.2
7.6
8
Operation
7
8.1
Planning and operational
control
7.1
8.5
8.2
Requirements for products and
services
7.2
8.5
8.3
Design and development of
products and services
7.3
8
8.4
Control of externally supplied
processes, products and services
7.4; 4.1.5
7.2
8.5
Production and service
provision
7.5
8.5
8.6
Release of products and
services
7.4.3; 8.2.6
8.7
Control of non-conforming
outputs
8.3
9
Performance evaluation
8
9
9.1
Monitoring, measurement,
analysis and evaluation
8.1; 8.2; 8.4
9.1; 8.6
9.2
Internal audit
5.7
9.2
9.3
Management review
5.6
9.3
10
Improvement
8.5
10
10.2
Non-conformity and corrective
action
8.3; 8.5.2
10
10.3
Continuous improvement
8.5
10
With the details of each of the requirements to be considered,
a checklist with 63 items was created as a tool to carry out the
initial diagnosis. Based on PAS 99:2012 the requirements of the
integrated management system included in the list are divided
according the PDCA cycle: Plan 29 items; Do 23 items;
Check – 7 items, and Act – 4 items.
The checklist was answered in a group activity by consensus
of all the members of the Board of Directors (7) and the
Scientific Council of the Biomaterials Center (5) of the
Biomaterials Center, under the coordination and advice of the
authors of this work. For each item on the list, three response
levels were established: fully implemented, partially
implemented, and not implemented, and observations
illustrating how the requirements were met, were done. In this
way were identifies which items are meet within the framework
of the system already implemented in BIOMAT and the
existing shortages, fundamentally to strengthen R&D&I
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management.
The vision of the Center by 2023 is: to be leaders in Cuba in
the research and development of biomaterials, achieving their
introduction in social practice and the creation of exportable
products with high added value, as well as in the training of
specialists in the science of biomaterials [34].
The research carried out in BIOMAT is channeled through
their incorporation in the current practices of quality
management (QM). According to the results obtained, KM
activities are perceived with a higher degree of accomplishment
in the Center than those related to QM and IM, with 60% - 80%
of the respondents in total agreement on the following aspects:
- The organization has effective training programs for new
workers (KM).
the projects approved in the National Programs of Basic- Participation in knowledge networks (KM).
Sciences and Nanotechnology and in collaborative projects- The search for updated and relevant information is carried out
with foreign institutions. The scientific results obtained gave (KM).
rise to publications, as well as the accomplishment of academic- The causes of quality system non-conformities are used as a
and scientific degrees. However, in recent years the innovative source of knowledge (KM).
capacity of the Center has been diminished due to the lack of its- The knowledge of the people of experience in the organization
own resources, derived from the commercialization of its is transmitted (KM).
products or due to budget allocations for Science and- The organization has the documented information necessary for
Innovation. These causes, together with the deterioration of the the development of its activities (QM).
Center's infrastructure and the lack of incentives for innovation,- Organizational workers support innovative ideas (IM).
has led researchers to focus their efforts mainly to research and
- The managers of the organization promote the development of
publication of their results, aspects that are fundamental in the
development of their professional careers.
It should be noted that in the medical products sector,
including biomaterials, there are multiple challenges to
innovation derived from the regulations established to protect
society from products that may create a risk to patients due to
their form of action or because they are not effective for the
required treatment [36]. Hence the difficulties to innovate in
biomaterials and the need for large resources to close the cycle
from research to the use of the products [37].
Every day new technologies are generated in the field of
materials for medical use, and disruptive innovations come
mainly from the field of biotechnology and nanotechnology,
with the introduction of third-generation biomaterials and the
tissue engineering. All this development requires infrastructure,
resources and high-level scientific specialists in line with these
trends. In Cuba, with an important development in
biotechnology, the strengthening of alliances with this sector
would result in greater contributions to science that the staff of
BIOMAT is capable of making, but that does not find an
adequate productive outlet at this time.
The NC 1307:2019 standard raises the need to carry out an
analysis of the internal and external context, as well as the
selection of R&D&I ideas to be developed in the project
portfolio, considering risk factors, among other aspects. The PS
08 Design and development strategy approved in BIOMAT
establishes the activities required for the design and products
development, following quality management standards,
including planning, review, verification, validation, transfer of
design and development and changes in the products, as well as
creativity and innovation (IM).
Although several authors [38] have found a positive
relationship between QM and performance, as well as between
KM and innovation, which in turn impacts the performance of
organizations, in the results of the survey applied in BIOMAT,
no significant relationships were found between the studied
attributes of QM, KM and IM and the organizational
performance evaluated by the results in new products, improved
processes and customer satisfaction. The lack of resources for
research and incentives at the individual level to achieve
innovative results can be factors that interfere the analyzed
relationships and make them not perceived by the members of
the organization.
When planning the QIIMS, the organization must take into
account internal and external analysis, the needs, expectations
and interested parties requirements, as well as the integrated
policy of the organization, and must determine the risks and
opportunities that need to be addressed in order to: ensure that
the QIIMS achieves its intended results; prevent or reduce
unwanted effects and achieve continuous improvement.
Likewise, the organization must plan actions to deal with these
risks and opportunities, integrate and implement them in the
system processes, as well as evaluate the effectiveness of said
actions.
BIOMAT carries out comprehensive risk management,
including the risks related to R&D&I [39]. However, when
analyzing the risks that affect innovation, only the lack of
financing for projects by products is identified, without delving
into other aspects that could affect the performance of the
Center in innovation processes, such as the risks related with:
the responsibilities and authorities for these activities.
- loss of highly trained personnel;
However, projects by products existing have been halted due to
- technological surveillance and competitive intelligence
lack of financing and new ones have not been generated to
- management of intangible assets and intellectual property;
incorporate the research results into new products.
- selection of collaborators and forms of collaboration;
The considerations made are consistent with the results of a
- internal collaboration;
previous study [27] in which a survey was carried out with
- forms of commercial exploitation of the results.
BIOMAT managers and workers to find out their perceptions
about how the categories knowledge management (KM) and
innovation management are manifested (IM), starting from
Although the research activities are part of the current
BIOMAT management system, not all of them are within the
scope of certification by the NC-ISO 9001:2015 standard, so to
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implement the QIIMS, the R&D&I activities that should be
further developed in the integrated system, were identified.
They are:
-
Idea management.
-
Development of projects by products.
-
Protection of results.
-
Transfer of results.
-
Market studies.
-
Monitoring and measurement of R&D&I management and its
results.
Although R&D&I activities are carried out in the current
management system, they must be strengthened to achieve
better performance in innovation. For each element of the
vision, the current strategies should be reviewed and the
pertinent actions strengthened. In addition, the general
documents of the System should be reviewed to further
incorporate planning, monitoring and improvement of R&D&I
activities. Among the documents to review are:
-
Management manual.
-
Policy and strategic objectives.
-
PS 01 Responsibilities, authority, relationships and functions of
the personnel.
-
PS 02 Control of documented information.
-
PS 03 Comprehensive risk management.
-
PS 04 Planning and review of the Management System.
-
PS 05 Identification of needs and allocation of resources.
-
PS 08 Design and development strategy.
-
PS 13 Internal audits.
-
PS 16 Corrective Actions.
On the other hand, the person in charge of the Research and
Product Development process must assess the usefulness and
convenience of documenting a specific procedure for
knowledge management, technological surveillance and
competitive intelligence, to facilitate the strengthening and
monitoring of these activities. For this, it is useful to consult the
standards:
-
NC 1308:2019 R&D&I Management: Monitoring and
intelligence system [13].
-
ISO 30401:2018 Knowledge management systems.
Requirements [40].
The implementation of QIIMS in the Biomaterials Center
will be an organizational innovation that will facilitate the
development of innovative products for the National Health
System, based on the competencies of the researchers and the
use of recognized management tools. It shall contribute to the
achievement of the Vision of the organization and the
fulfillment of the strategic objectives planned by the Center
Management.
V.
CONCLUSION
The integration of management systems brings benefits to
organizations, but due to its complexity, this change process
must be adequately planned and carried out. As a methodology
for the change, four stages are proposed in this work: context
analysis; planning of the integration process; implementation;
maintenance and improvement. The diagnosis made for the
integration of quality and innovation management systems 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, allowed to identify the changes needed in the
existing system. To do this, a diagnostic instrument 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 performance and monitoring of innovation activities.
ACKNOWLEDGMENT
The authors would like to thank PhD. Yaymarilis Veranes
Pantoja, Director, and PhD. Amisel Almirall La Serna, Head of
the Department of Ceramic and Metallic Biomaterials, of the
Biomaterials Center for reviewing the manuscript.
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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.
ORCID: https://orcid.org/0000-0002-0561-6678
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.
ORCID: https://orcid.org/0000-0002-2727-2183
Scientia et Technica Año XXVIII, Vol. 28, No. 04, octubre-diciembre de 2023. Universidad Tecnológica de Pereira
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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.
ORCID: https://orcid.org/0000-0001-5758-4391