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

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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.

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

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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

Context of the organization.

4; 7.9

4.4

Management system and its

processes

4.1

4.3

Leadership

5.1-5.5;

5; 7.1

Planning

5.4; 8.5.4

Support

7.1

Resources

7.2

7.1.

Organization knowledge

6.2

7.7;7.8;7.9;8.2

7.2

Competence

6.2

7.3

Awareness

6.2

7.4

Communication

5.5.3

7.5

Documented information

4.2

7.6

Operation

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

8.4

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

Performance evaluation

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

Improvement

8.5

10.2

Non-conformity and corrective

action

8.3; 8.5.2

10.3

Continuous improvement

8.5

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.

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