Implementing Healthcare Innovation via ISO Standards: An

Exploratory Literature Overview

Carlotta D’Alessandro

, Antonio Licastro

, Alberto Bongiorno

Katarzyna Szopik-Depczyńska

and Giuseppe Ioppolo

Department of Economics, University of Messina, Via del Verdi, Messina, Sicily, Italy

Department of Corporate Management, Institute of Management, University of Szczecin, Poland

Keywords: Healthcare, ISO, Drivers, Barriers, Digital Technologies.

Abstract: The healthcare sector faces increasing pressure to improve quality while reducing its environmental impact.

This study presents an exploratory semi-systematic literature review investigating the implementation of the

most important ISO standards (9001, 14001, 45001, 26000, and 50001) in healthcare organizations, focusing

on implementation of drivers, barriers, and the role of digital technologies. Through analysis of peer-reviewed

articles from Web of Science published between 2010 and 2024, the study aimed to examine driving forces

and barriers affecting ISO implementation in healthcare settings, while also investigating the potential role of

digital technologies in addressing implementation obstacles. While ISO 9001 dominates implementations,

driven by desires for process optimization and improved patient care, significant barriers persist, including

lack of commitment, financial constraints, and administrative burdens. Despite limited explicit discussion of

technological solutions in the literature, digital technologies could facilitate ISO implementation, particularly

through integration with healthcare-specific ISO standards. However, technology adoption might exacerbate

existing challenges related to training and organizational commitment. Understanding the implementation

dynamics provides healthcare organizations with insights for decision-making regarding ISO adoption.

Furthermore, the findings can support policymakers in developing targeted initiatives for smoother ISO

standard implementation across the healthcare sector, laying the groundwork for future research in this

important area.

1 INTRODUCTION

The healthcare industry stands as a fundamental pillar

of societal well-being and economic development,

representing one of the largest service sectors in

OECD countries with projections indicating

continued growth in the coming decades (Weisz et al.,

2020).

Nonetheless, its growth might contribute to

climate change (Weisz et al., 2020). Indeed, the

global healthcare sector's annual greenhouse gas

emissions are comparable to those of 514 coal-fired

power plants (Mominkhan et al., 2023). In OECD

https://orcid.org/0000-0002-7361-4201

https://orcid.org/0000-0002-4735-6237

https://orcid.org/0009-0003-1997-5967

https://orcid.org/0000-0002-3054-0660

https://orcid.org/0000-0003-0262-8435

countries, the healthcare sectors account for 5% of

national carbon dioxide emissions (Mominkhan et al.,

2023). Furthermore, the healthcare sector's

contribution to pollution, in turn, has negative

consequences for public health (Eckelman et al.,

2018).

In response to these challenges, many healthcare

organizations have turned to standardized

management systems. Indeed, various standards for

healthcare operations have been established by the

International Organization for Standardization (ISO).

Implementing ISO standards has been linked to

positive outcomes in healthcare, including greater

224

D’Alessandro, C., Licastro, A., Bongiorno, A., Szopik-Depczy

nska, K. and Ioppolo, G.

Implementing Healthcare Innovation via ISO Standards: An Exploratory Literature Overview.

DOI: 10.5220/0013428000003956

Paper published under CC license (CC BY-NC-ND 4.0)

In Proceedings of the 7th International Conference on Finance, Economics, Management and IT Business (FEMIB 2025), pages 224-231

ISBN: 978-989-758-748-1; ISSN: 2184-5891

patient satisfaction and safety and enhanced

profitability since they provide a robust framework

for process management and continuous

improvement (Villa-Gallón et al., 2024).

A recent study conducted by Creixans-Tenas et al.

(2019) identified the ISO standards with the most

significant implications for healthcare, which are:

ISO 9001 (Quality Management System, ISO 14001

(Environmental Management System, ISO 45001

(Occupational health and safety management

systems), ISO 50001 (Energy Management System),

and ISO 26000 (Guidance on Social Responsibility),

(ISO 2010; ISO 2015a; ISO 2015b; ISO 2018a; ISO

2018b). Indeed, potential benefits of ISO

implementation are well known, as demonstrated in

literature. For instance, quality following ISO 9001

adoption, educational institutions realized sustained

improvements in service (Arribas Díaz et al., 2018).

Integrated ISO systems can lead to operational

efficiency in the manufacturing sector (Fahmi et al.,

2021), as well as improved operational processes and

customer relations in the food industry (Agus et al.,

2020). Furthermore, simultaneous implementation

of ISO 45001 and ISO 14001 can reduce

administrative overhead and lead to more robust

management systems (Pauliková et al., 2022).

Nevertheless, obstacles to ISO implementation

remain significant in healthcare organizations. Such

is the case of constraints on resources, high costs

related to certification, or opposition within

organizations, (Carrillo-Labella et al., 2020; Mitchell

& Fakhruddin, 2022). Such challenges largely depend

on the heterogeneity of organizational types, sizes

and missions, creating various degrees of needs and

capabilities for implementing ISO standards.

A possible solution to address such issues might

lie in digital technologies. For instance, Artificial

intelligence (AI) or Machine Learning (ML) can

transform healthcare, leading to a future with

increased personalization, precision, predictive

capabilities, and portability (Channapatna 2023).

Previous reviews have focused on specific

aspects: Rakhmawati et al.'s (2014) comprehensive

review of ISO 9001 in healthcare revealed that while

quality management standards are widely adopted,

there is no clear evidence of their effectiveness in

driving broader sustainability outcomes. Similarly,

Sherman et al.'s (2020) systematic review identified a

critical need for standardized approaches to measure

and improve environmental performance in

healthcare, but did not explore how existing ISO

frameworks could fulfil this need.

Indeed, an overview focusing specifically on

healthcare remains unexplored. In addition, an

exploration of how technologies might foster ISO

implantation is also needed. Considering this, the aim

of this exploratory review is to provide an overview

of the primary factors leading to ISO implementation

or hindering as well as exploring which digital

technologies can overcome implementation issues.

Hence, this research aims to address the following

questions:

• What are the primary factors promoting and

hindering the adoption of the most relevant ISO

standards (14001, 45001, 9001, 26000, and

50001) in healthcare institutions?

• What technologies can healthcare organizations

employ to effectively overcome ISO

implementation barriers?

Understanding these implementation dynamics is

important for developing effective strategies that

promote widespread ISO adoption in the healthcare

sector, thus overcoming its environmental challenges.

The subsequent sections of this paper are

structured as follows: first, the Methodology section

details the systematic approach used for literature

selection

and

analysis;

second,

the

Results

and

Discussion section presents and discuss the key

findings, followed by conclusive remarks.

2 METHODOLOGY

To answer the abovementioned research questions

this study adopted an exploratory semi- systematic

literature review. A semi-systematic review merges

the exhaustive nature of systematic reviews with the

interpretative adaptability of narrative ones (Snyder,

2019). To ensure methodological soundness and

clarity, the researchers strictly adhered to the

Preferred Reporting Items for Systematic Reviews

and Meta-Analyses (PRISMA) guidelines (Page et

al., 2021).

The research focused exclusively on Web of

Science as the primary academic database. Keywords

selection encompassed the most relevant ISO

standards according to Creixans-Tenas et al. (2019).

Hence, the study concentrated on five specific ISO

standards: ISO 9001, ISO 45001, ISO 14001, ISO

26000, and ISO 50001, all contextualized within the

healthcare domain.

Only English peer-reviewed articles and reviews

published in academic journals were considered,

aligning with recommendations from scholarly

research that emphasize the superior utility of such

publications (Ceulemans et al., 2015; Saunders et al.,

2009). To ensure contemporaneity and relevance, the

temporal boundary was defined from 2010 to 2024,

Implementing Healthcare Innovation via ISO Standards: An Exploratory Literature Overview

225

Figure 1: PRISMA Flowchart.

coinciding with the issuance of ISO 26000 in 2010.

Studies were selected if there are explicit mentions of

challenges, barriers, drivers, or benefits related to ISO

standards in healthcare contexts.

An initial search generated 51 potential studies,

which were subsequently refined through progressive

filtering. Document type, language constraints and

temporal filter further narrowed the selection to 26

articles. Examination of titles and abstracts

culminated in 14 studies, with a final selection of 11

articles after full text reading. The selection process

is illustrated in figure 1.

3 RESULTS AND DISCUSSION

Among the 11 articles analyzed, the overwhelming

majority (9 out of 11) mentioned ISO 9001:2015 as the

most important standard to be implemented in

healthcare. This dominance of ISO 9001 reflects a

traditional focus on quality management in healthcare

organizations, driven by patient safety concerns and

regulatory requirements. While such focus

demonstrates a clear understanding of its immediate

benefits for patient care, it also suggests that

healthcare organizations may need guidance in

recognizing the value of other ISO standards that

could complement their quality management efforts.

Indeed, this inadvertently overshadows other crucial

aspects of healthcare operations that could benefit

from standardization.

The complete absence of ISO 26000:2010

implementation studies in the sample is particularly

noteworthy, implying an important gap between

healthcare organizations' social responsibilities and

their management practices. Healthcare organizations

bear significant social responsibility towards both

patients and employees, and ISO implementation

could help achieve sustainable development

objectives (ISO 2010). This gap is especially

concerning given healthcare's central role in

FEMIB 2025 - 7th International Conference on Finance, Economics, Management and IT Business

226

community wellbeing and social equity. The lack of

ISO 26000 adoption might indicate either limited

awareness of the standard's potential benefits or

challenges in translating social responsibility

principles into concrete healthcare practices. Indeed,

current approaches to promoting ISO standards in

healthcare appear be too narrowly focused on

operational aspects while overlooking broader

societal impacts.

The limited exploration of ISO 14001:2015 and

ISO 50001:2018 in the literature (found in only 3

articles) suggests that environmental and energy

management remain secondary priorities in healthcare

organizations' standardization efforts. This finding is

particularly relevant given the healthcare sector's

significant environmental footprint. Organizations

might benefit from an integrated implementation

framework that demonstrates how environmental and

energy management standards can support and

enhance quality management objectives, rather than

competing with them for resources and attention. Dion

et al. (2023) demonstrated that adopting ISO

50001:2018 guidelines can lead to better energy

efficiency in hospitals, providing concrete evidence of

potential benefits. However, the limited adoption of

these standards might indicate a disconnect between

healthcare organizations' environmental impact

awareness and their willingness to implement

systematic solutions. Seifert's (2018) findings

regarding barriers to ISO 14001:2015 implementation

- particularly lack of commitment and awareness -

point to deeper organizational challenges. These

barriers might reflect broader institutional resistance

to environmental initiatives in healthcare settings,

where immediate patient care concerns often

overshadow longer-term sustainability goals. This

suggests a need for better integration of environmental

management with core healthcare operations.

The heavy focus on quality management with

limited attention to environmental, energy, and social

responsibility standards, raises questions about the

healthcare sector's readiness to address its broader

societal impacts. This imbalance might need to be

addressed through policy interventions, enhanced

awareness programs, or revised implementation

frameworks that better integrate different ISO

standards.

3.1 Barriers and Drivers

Nearly half of the analyzed articles signaled lack of

commitment, awareness and knowledge of either the

top management or employees, as the predominant

form of barrier to ISO implementation. Indeed,

efficient fulfilment of standards can be realized only

with a strong level of commitment (López-Púa et al.,

2023). The fact that this barrier persists across different

types of institutions suggests potential systemic issues

in how ISO standards are introduced and promoted

within healthcare organizations. This could indicate a

need for more sector-specific implementation

approaches that account for healthcare's unique

organizational dynamics.

ISO implementation can also become very

financially demanding (Dion et al., 2023; López-Púa

et al., 2023). Financial demands come in the form of

certification fees, training the employees and

logistics. Securing funds in the context of public

hospitals, for the purpose of financing certifications,

can be problematic (Veronese et al. 2020). This is

particularly significant for public healthcare

institutions, where the competing demands of

immediate patient care needs and long-term quality

improvements create complex resource allocation

challenges. The variation in financial challenges

between public and private institutions suggests a

need for differentiated support mechanisms and

implementation strategies.

The numerous administrative tasks required for

obtaining certification may also impede ISO

implementation (Franchina et al., 2023; López-Púa et

al., 2023).

As mentioned at the beginning, the diverse nature

of healthcare organizations can create obstacles in

implementing ISO standards. Indeed, Different

organizations may have distinct experiences

(López-Púa et al., 2023; Nurcahyo et al., 2020) and

may implement ISO standards in their own unique

ways (López-Púa et al., 2023). While this diversity

complicates standardization efforts, it may also shed

light onto how ISO standards can be adapted to

different healthcare contexts. The organizational

changes triggered by ISO implementation suggest

that these standards act not just as management tools

but as catalysts for broader institutional

transformation (Johannesen & Wiig, 2020).

Additional hurdles in ISO implementation include

insufficient training (Silva et al., 2017; Seifert 2018;

Franchina et al., 2023) and limited understanding

among stakeholders about green operations and

comparative energy costs, especially in relation to

energy management systems (Dion et al., 2023).

Moreover, the ability to access various IT

systems has been recognized as an impediment to

implementing ISO 9001:2015 (Avruscio et al., 2022).

Institutions are primarily motivated by the

potential for internal management enhancement and

process optimization (Avruscio et al., 2022; Corsi et

Implementing Healthcare Innovation via ISO Standards: An Exploratory Literature Overview

227

al., 2020). This manifests through the establishment

of better-quality processes, systematic internal audits,

and robust risk management approaches (Franchina et

al., 2023).

The drive for continuous improvement emerges as

a recurring theme across multiple studies (Franchina

et al., 2023; López-Púa et al., 2023; Silva et al., 2017),

suggesting its fundamental role in ISO adoption.

From a patient-centric perspective, healthcare

organizations are motivated by the potential to

enhance patient satisfaction (Dion et al., 2023;

López-Púa et al., 2023) and improve patient safety

through better diagnosis processes and measurement

quality (Farfán-Vargas et al., 2024; Huf et al., 2024).

The economic dimension also plays a significant role,

with institutions seeking cost efficiency and

improved staff productivity (Dion et al., 2023).

External factors, such as governmental requirements,

can also serve as catalysts for ISO implementation

(Nurcahyo et al., 2019).

Furthermore, the standards' implementation is

viewed as a strategic tool for enhancing

competitiveness (Farfán-Vargas et al., 2024) and

promoting sustainability in healthcare systems (Silva

et al., 2017).

3.2 Digital

Innovations

and

ISO

Standards in Healthcare

Despite the potential of digital technologies to

facilitate ISO implementation in healthcare, this

review reveals limited explicit discussion of

technological solutions in the current literature.

However, some studies highlight both existing

applications and future needs. The implemented

technologies range from basic digitalization and

automation processes to more sophisticated IT

systems (Huf et al., 2024). Telemedicine emerges as

a notable technological application in healthcare

settings pursuing ISO compliance (Farfán-Vargas et

al., 2024), representing an interesting convergence of

quality management and digital innovation. This

intersection suggests that digital technologies might

serve dual purposes: facilitating ISO compliance

while simultaneously modernizing healthcare

delivery. However, the limited explicit discussion of

technological solutions in the literature points to a

potential disconnect between quality management

practices and digital transformation initiatives in

healthcare organizations.

The need for digital tools and innovative

solutions to support ISO implementation is explicitly

recognized (Dion et al., 2023; Franchina et al., 2023),

suggesting an important opportunity for integration

with existing healthcare-specific ISO standards for

digital technologies. For instance, while healthcare

organizations are increasingly adopting digital

medical technologies to enhance accessibility and

flexibility (Senbekov et al., 2020), standards like ISO

13131 for telehealth services could complement

quality management systems by ensuring patient

safety in digital environments (ISO 2021; Meijer &

Taylor, 2022). Similarly, as healthcare organizations

implement sustainability-focused technologies such

as real-time consumption monitoring software and

renewable energy systems (Dion et al., 2023), they

could benefit from integrating these with existing

digital health standards. The healthcare sector's

digital transformation, encompassing Internet of

Medical Things (IoMT), telemedicine systems, and

electronic health records (EHRs) (Rahim et al., 2024),

suggests that a more integrated approach to ISO

implementation could be beneficial. This could

include combining traditional management system

standards with healthcare-specific digital standards

like ISO 11073 for remote patient monitoring (ISO

2008) and ISO 27799 for healthcare information

security (ISO 2016). Such integration could create

synergies that address both operational efficiency and

digital innovation needs while ensuring compliance

with quality, environmental, and safety requirements.

This gap between the recognized need for

technological innovation and actual implementation

suggests an important area for future research and

development. The limited discussion of digital

technologies in the reviewed literature, coupled with

explicit calls for more innovative tools, indicates an

emerging awareness of technology's potential role in

facilitating ISO implementation, even though concrete

applications remain underexplored.

4 CONCLUSIONS

This exploratory review has provided an overview of

the implementation dynamics of ISO standards in

healthcare organizations, addressing the drivers,

barriers, and potential role of digital technologies.

The dominance of ISO 9001:2015 demonstrates

healthcare organizations' commitment to quality

management yet also reveals potential gaps in

addressing other critical areas. The notable absence

of ISO 26000 implementation studies and limited

adoption of environmental standards suggests

healthcare organizations may be overlooking

opportunities to address their broader societal and

environmental impacts. This imbalance requires

attention from both healthcare leaders, policymakers

FEMIB 2025 - 7th International Conference on Finance, Economics, Management and IT Business

228

as well as researchers to ensure a more

comprehensive approach to standardization.

The prevalence of organizational resistance and

lack of commitment indicates a need for more

effective change management strategies specifically

tailored to healthcare settings. Financial constraints,

particularly evident in public healthcare institutions,

necessitate innovative funding mechanisms and

policy support. Administrative burdens could be

mitigated through better integration of management

systems and strategic use of digital technologies.

The relationship between digital technologies and

ISO implementation emerges as a critical area for

development. While technology shows promise in

addressing certain implementation barriers,

particularly administrative challenges, its successful

integration requires careful consideration of

organizational readiness and capacity. It is important

to note, in fact, that technological solutions might

exacerbate certain challenges, such as the existing

issues with lack of training and commitment, if not

properly managed.

Healthcare organizations must develop

comprehensive strategies that align digital

transformation initiatives with ISO implementation

efforts. Healthcare administrators should consider

developing integrated approaches that balance quality

management with other ISO standards, while

policymakers could work to develop targeted support

mechanisms for public healthcare institutions.

Technology providers might focus on creating

healthcare-specific solutions that address ISO

implementation challenges while minimizing

additional training requirements.

Future research should examine successful ISO

implementation strategies in different healthcare

contexts, analyze the experiences of public versus

private healthcare institutions, and investigate the

barriers to implementing environmental and social

responsibility standards. Empirical studies examining

how digital technologies specifically address ISO

implementation barriers in healthcare settings are

needed. Additionally, scholars should assess the long-

term impacts of integrated ISO systems on healthcare

outcomes and evaluate digital technology's role in

facilitating ISO implementation. Finally, healthcare

administrators and policymakers could benefit from

investigating how digital transformation might

influence organizational commitment and training

requirements in the context of ISO implementation.

Understanding of ISO implementation dynamics,

coupled with strategic technological integration and

targeted policy support, will be crucial for healthcare

organizations to successfully balance quality

improvement, environmental responsibility, and social

impact while maintaining operational efficiency in an

increasingly complex healthcare landscape.

ACKNOWLEDGEMENTS

Co-financed by the Minister of Science under the

"Regional Excellence Initiative" Program.

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