Deliverable 06 - SMART Goals
soniam
EBSCO-FullText-12_14_20254.pdf
Elektronik Sosyal Bilimler Dergisi www.esosder.org
Electronic Journal of Social Sciences e-ISSN:1304-0278
Ekim/October(2025) - Cilt/Volume:24 - Sayı/Issue:4 (1507-1525)
Makale Türü/Article Type: Araştırma Makalesi/Research Article
Geliş Tarihi/Received Date: 21.04.2025 – Kabul Tarihi/Accepted Date: 05.09.2025
Atıf İçin/For Cite: ÖZKAN Ö., “The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on
Business Performance: A Research in Health Care Sector”, Elektronik Sosyal Bilimler Dergisi, 2025;24(4):
1507-1525
https://doi.org/10.17755/esosder.1681104
License: CC BY-NC 4.0
The Regulatory Role of Iso 9001 In the Effect of Strategic
Planning on Business Performance: A Research in Health Care
Sector
Stratejik Planlamanın İşletme Performansı Üzerindeki Etkisinde ISO 9001’in
Düzenleyici Rolü: Sağlık Sektöründe Bir Araştırma
Ömer ÖZKAN1
Öz
Stratejik planlamanın işletme performansı üzerindeki etkisinde ISO 9001 kalite yönetim sisteminin düzenleyici
rolünün incelendiği bu çalışmada özellikle sağlık sektöründe faaliyet gösteren kuruluşlarda kalite yönetim
sistemlerinin stratejik yönetim süreçlerine olan katkısına odaklanılmıştır. Araştırmada stratejik planlama düzeyi
ve işletme performansı Kuşluvan ve Eren (2008) ile Canbaz ve Yıldız (2014) tarafından geliştirilen ölçeklerle
ölçülmüştür. Veriler, Hayes (2008) tarafından geliştirilen PROCESS makro modeli kullanılarak analiz edilmiş,
moderatör değişken olarak ISO 9001 belgesine sahip olma durumu dikkate alınmıştır. Bulgular, stratejik
planlamanın işletme performansını anlamlı düzeyde etkilediğini ve bu etkinin ISO 9001 kalite yönetim sistemi
tarafından güçlendirildiğini göstermektedir. Elde edilen sonuçlar, ISO 9001 uygulamalarının sadece operasyonel
kaliteyi değil, stratejik yönetişim süreçlerini de olumlu etkileyerek işletme başarısına katkı sağladığını ortaya
koymaktadır. Bu bağlamda, sağlık sektöründe stratejik başarı için kalite sistemlerinin entegrasyonu kritik bir unsur
olarak öne çıkmaktadır.
Anahtar Kelimeler: Stratejik planlama, İşletme performansı, ISO 9001
Abstract
This study, which examines the regulatory role of ISO 9001 quality management system in the effect of strategic
planning on business performance, focuses on the contribution of quality management systems to strategic
management processes in organizations operating in the health sector. In the study, strategic planning level and
business performance were measured with scales developed by Kuşluvan and Eren (2008) and Canbaz and Yıldız
(2014). The data were analyzed using the PROCESS macro model developed by Hayes (2008), and the status of
having ISO 9001 certification was taken into consideration as a moderator variable. The findings show that
strategic planning has a significant effect on business performance and this effect is strengthened by the ISO 9001
quality management system. The results obtained reveal that ISO 9001 practices contribute to business success
positively affecting not only operational quality but also strategic governance processes. In this context, the
integration of quality systems stands out as a critical element for strategic success in the healthcare sector.
Keywords: Strategic planning, Business performance, ISO 9001
1 Dr., Corporate Quality Management Group Manager Socar Türkiye, [email protected],
https://orcid.org/0000-0002-0752-307X , https://ror.org/00tcejj11
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1. Introduction
Today’s competitive job environment make the effectiveness of strategic management processes
more important than ever especially in the fields which is complicated, service focused and has quality
expectation like health sector. The objectives like improving service quality continuously, effective
resource utilization, providing patient satisfaction and obtaining sustainable competitive advantage
direct health care organizations to a more planned and systematic management mentality. At this point,
strategic planning process features as a fundamental management tool that provides complying with
environmental variables, determining long-term objectives and a road map.
Strategic planning does not remain with resource allocation, it is also a comprehensive process
that direct-acting decisions are made during it. Running of this process efficiently has a more essential
role in the sectors that prioritize public welfare and affects human life directly. However, creating a
positive effect on business performance singly is not under warranty for strategic planning. Success of
the strategic plans are closely related to internal dynamics and application processes of the organization.
In this context, quality management systems have been evaluated as the regulatory factors that shape
the effect of strategic planning on performance and have been examined with an ever-increasing interest.
ISO 9001 standard which is the well accepted one among the quality management systems and
has an international validity, aims to develop management effectiveness of businesses with its process-
based approach and initiator structure of continual improvement.
The organizations have ISO 9001 certificate, adopting a quality-focused management culture,
manage not only operational process but also strategic decision making and practising processes through
a constituted system. From this aspect, ISO 9001 is evaluated as a system that increases reaching
strategic capacity of the businesses and creates an indirect but strong effect on performance.
It can be remarked that the relation between strategic planning and business performance may
display variability rather than a direct and implicit structure. In this regard, the presumption remarks
that quality management systems like ISO 9001 can act a regulatory role in effect of strategic planning
on business performance. Especially, process standardization, constituting organizational memory and
developing performance measurement systems are predicted to contribute to business performance
improving effectiveness of strategic planning.
Examining whether ISO 9001 has a regulator (moderating) effect on relation between strategic planning
process and business performance forms the focus of this study.
Since limited availability of studies in literature analysed this relation empirically especially in
the context of health sector, this condition makes the current research important in terms of both
theoretical contribute and practical results. Performing the research in health care organizations operate
around İzmir, provides findings to carry a guideway quality in terms of developing local policies and
institutional governance. Accordingly, the main objective of the study is to reveal whether ISO 9001
quality management system acts a regulatory role in effects of strategic planning activities on business
performance or not, under the light of empirical data. In this context, through the research model and
applied statistical analyses which have been developed in the light of related literature, suggestions
towards increasing strategic management processes quality for the businesses which are active in the
health care sector.
2. Conceptual Framework
2.1. Concept of Strategic Planning and Its Place in Health Sector
Strategic planning is determination of direction and concept which are necessary to reach long-
term objectives of a business allocating effectively (Johnson et.al, 2008). This concept has been
advanced because of the complicated competition environment appeared especially in large industry
organizations in 1950s and 1960s. It can be said that strategic planning was defined by Chandler (1962)
for the first time. According to him, strategy is defined as “determining long-term aims and objectives
of a business, allocating essential ways action and sources to reach these objectives.” Over time, strategic
planning became being adopted in public institutions beside private sector, apart from being a military-
based discipline. In 1980s together with increasing competitiveness, strategic planning became an
The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on Business Performance: A Research in
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indispensable tool in the direction of objectives of the businesses like sustainable agility and
performance development (Mintzberg et.al, 2005).
Strategic planning is one of the basic components of strategic management. Strategic
management process; consists of four main stages as environmental analysis, formulation of strategies,
practicing the strategies and evaluation (Wheelen et.al, 2015). During this process, strategic planning
has been used intensely especially in environmental analysis, formulation of strategies stages.
Organizations set their goals evaluating internal and external environmental factors and determine
second strings to reach these objectives. Strategic planning provides this process to be carried out on a
rational and systematic baseline. In this regard, strategic planning is not only a scheming process but
also a managerial tool which encourages strategic thinking, helps clarifying organizational mission and
vision (Bryson, 2018). Besides, during the process of practicing continual improvement is provided
following effectiveness of strategies with performance measurement and feedback mechanisms.
Since health care sector has the characteristic of public service and being related to human life
directly, attributes a special importance to strategic management approaches. Growing population,
increasing demands for health service accessing, cost pressure and social expectations towards service
quality have directed health organizations to more effective and productive management types (Ginter
et.al, 2018).
Strategic planning is used in health care sector not only to provide competitive advantage but
also used as a tool for effective and productive resource utilization. Especially in public hospitals,
strategic planning; has a significant role in achieving great many objectives like diversification of
services, performance measurement, cost controlling and increasing patient satisfaction (Leggat, 2007).
Moreover, in health sector strategic planning is also important in terms of stakeholder management.
Since health services include a lot of various stakeholders (doctors, nurses, patients, insurance
institutions, regulatory authorities etc.), running this complicated structure in harmony is possible with
strategic approaches (Poister, 2010).
Among fundamental objectives of strategic planning increasing organizational productivity, effective
management of activities and achieving to long-term success take place. While productivity means
producing maximum output with existent resources; effectiveness is using correct methods to reach
correct objectives (Kaplan and Norton, 1996). These two concepts in health services are intertwined
with though objectives like reducing the costs per patient and developing the service quality. Long-term
achievement is usually paired with the concept of sustainability. Since strategic planning aims to manage
not only present day but also future, increases organizational durability. For example, in crisis period
like COVID-19 pandemic, the health care organizations with strong strategic planning ability could
provide service continuity easier (WHO, 2021).
2.2. Concept of Business Performance and Performance Indicators Peculiar to
Healthcare Sector
Business performance is a multi-dimensioned concept which expresses success of an
organization for achieving specific objectives. This concept is evaluated via both quantitative and
qualitative criterions and generally includes financial, operational, customer-oriented and organizational
dimensions (Kaplan & Norton, 1996). Business performance measurement is discussed in a large frame
that cannot be brought down to financial indicators just like profit and cost. Especially in service sectors
-like healthcare sector-, performance is mostly evaluated with the factors like service quality, customer
(patient) satisfaction, process effectiveness and sustainability of results (Bititci, Garengo, Ates, &
Nudurupati, 2015).
While performance is determined with the criterions like income, cost, productivity and
investment return; operational performance is mostly measured with criterions like effectiveness of the
processes, resource utilization level, service duration (Neely, Gregory, & Platts, 2005). Service quality
is a significant dimension especially in human-oriented services like health and usually evaluated over
the difference between expected service and perceived service (Parasuraman, Zeithaml, & Berry, 1988).
Patient satisfaction expresses general satisfaction level related to whole service and it is associated with
organizational image, reliability and royalty in healthcare services directly (Donabedian, 1988).
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Apart from traditional sectors, measuring business performance in health sector has more
complicated and multi dimensioned structure. Because healthcare service is a public service that
includes not only economic but also social, ethic and human dimensions. Therefore, while determining
performance indicators particular to healthcare sector, both clinic and managerial criterions have to be
evaluated together (Smith, Mossialos, & Papanicolas, 2008). Among major healthcare sector
performance indicators, patients’ waiting period (OECD, 2021), patient satisfaction (Cleary and McNeil,
1988) and clinic results (Arah et al., 2003) take place.
Patients’ waiting period states the speed of service access. It is important for especially
emergency services and operation appointments. Cut down in waiting period increases service
effectiveness and patient satisfaction (OECD, 2021). Patient satisfaction determines the common
satisfaction level about health services. This standard reflects the performance of the healthcare
organization both directly and indirectly and it is also one of the performance indicators in quality
management systems (Cleary & McNeil, 1988). Clinic results are important for evaluation of the clinic
results-based criterions like mortality rate, morbidity rate and performance assessments especially in
hospitals (Arah et.al, 2003). The interaction of these indicators and involvement of too many
stakeholders make performance management more complicated. Therefore, performance assessment in
healthcare organizations should be discussed with an integrative approach focuses on not only output
but also on the process (WHO, 2010). Strategic planning is accepted as a significant tool for improving
business performance. Planning process helps the organization to clarify long-term objectives, to
determine strong and weak sides and predict threats and opportunities making internal and external
environment analyses. This condition both provides effective resource utilization and make it possible
to determine the performance standards comply with objectives (Bryson, 2018).
In literature, there have been great number of studies review effect of strategic planning on
business performance. For example, Andersen (2004) revealed that effectiveness of strategic planning
process increases both financial and operational performances of businesses. Likewise, Ginter et.al
(2018) remark that strategic planning in healthcare sector create positive effects on patient satisfaction,
service quality and process productivity. Strategic planning does not remain with determining
performance indicators, also prepares the ground for the systems provide measurement and evaluation
of these indicators. Within this context, strategic planning and performance management are estimated
as mutually complementary processes (Poister, 2010). Further, providing participation of employees
work in planning process and other stakeholders, supports performance objectives and to become more
factual and acceptable (Nutt and Backoff, 1993).
2.3. ISO 9001 Quality Management System and Practises in Healthcare Sector
ISO 9001 is a standard that has been published by International Standardization Organization
(ISO) and devoted to Quality Management Systems (QMS). ISO 9001 identifies basic principles which
have to be adopted by the organizations by the aim of increasing customer satisfaction, improving
processes and developing a quality-based management mentality (ISO, 2015). The main purpose of the
standard is to provide organizations guarantee product and service quality with a systematic approach
and meet the customer expectations consistently (Hoyle, 2017).
ISO 9001 standards adopt a quality management model based on “Plan- Do- Check-Act”
(PDCA) circle. While this model aims institutionalising of continual improvement mentality, also
encourages performing decision making processes more consciously with risk-based mentality Goetsch
and Davis, 2016). As well as ISO 9001 is applicable for all sectors, carries significant importance in
terms of critical factors like process management, patient safety and satisfaction in healthcare sector.
In healthcare services ISO 9001 applications provides significant contributes in terms of
standardization of service quality, increasing patient satisfaction and developing institutional capacities
of healthcare organizations. Since healthcare sector is a high-risk sector and associated with human life
directly, practising quality management systems effectively is mandatory (Levett and Burney, 2014).
Practising ISO 9001 in healthcare sector provides recording the services, analysing processes and
improving the weaknesses systematically. In many countries healthcare organizations guarantee the
quality with ISO 9001 certification alongside accreditation. For example, plenty of hospitals and clinics
adopted ISO 9001 as basic foundation of quality systems (van den Heuvel et.al, 2005). While public
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hospitals in Türkiye use ISO 9001 together with SQS,private hospitals use ISO 9001 singly or together
with JCI standards. ISO 9001, like other quality standards, has a structure which provides collecting
patient information, analysing and evaluating them correctly and on time. It includes separately
identified standards for each unit in the hospital and prioritize the patient safe (Dikmen, 2016).
In the base of ISO 9001 standard “process approach” takes place. This approach bases on
managing the interactive processes of an organization systematically and monitoring and improving the
outputs of these processes (ISO, 2015). This approach in healthcare organizations; provides managing
whole stages like patient admission, tests, treatment, discharge and feedback. Continual improvement
principle is one of the indispensables of ISO 9001. This mentality focuses on not only correcting
mistakes but also preventing future problems. In healthcare services, this principle may develop tangible
results like patient safety, decreasing infection rates and shortening service delivery duration (Øvretveit,
2001).
Continual improvement also encourages participation of the employees into the process and in-
company learning. Patient satisfaction is discussed in customer orientation- principles context of ISO
9001. This approach aims satisfaction of the patients not only with treatment services but also with
offering the service. Several factors like waiting period, information policy, personnel attitudes and
physical conditions act on patient satisfaction (Andaleeb, 2001). ISO 9001 brings the necessity of
collecting and evaluating patient feedback systematically and performing improvements in the lights of
these information. Therefore, role of the patient as a customer is consolidated.
ISO 9001is not only a quality tool at operational level, it also offers a governance frame for
strategic management. Quality policies, objectives, risk assessments and performance monitoring
mechanisms that standard predicts are directly related to strategic planning processes (Sroufe &
Curkovic, 2008). In this regard, ISO 9001 provides healthcare organizations the opportunity of matching
strategic objectives with quality indicators and following whether these objectives are actualised or not
with objective data. Quality management systems increase applicability of strategic plans. Because, ISO
9001 obligates analysing the context of the organization, considering stakeholder expectations and
including leadership into the system strongly. From this aspect, ISO 9001 supports strategic mentality
to expand to all layers of the organization (Beheshti and Lollar, 2003).
3. Literature Research
Strategic planning has been accepted as a significant managerial tool for increasing business
performance, especially in complicated and competitive sectors, being planned ability is evaluated as
one of the basic factors for survival of the companies (Bryson, 2018). Integrating ISO 9001 quality
management system into strategic planning processes can be thought as a regulative factor that
consolidates this effect.
The relation between strategic planning and business has been researched in the field of
organizational theory and management sciences (Wijetunge and Pushpakumari, 2014; Skokan et.al,
2013; Rudd et.al, 2008; Falshaw et.al, 2006). In this regard, a lot of empirical studies reveal that planning
has a positive effect on business performance. Boyne and Gould-Williams (2003), in the study they
performed in public organizations in United Kingdom examined effect of strategic planning on
performance and detected that the organizations act based on planning become more successful in terms
of service quality, cost control and employee satisfaction. Researches remark that strategic planning
provides making the right decision for source allocation increasing organizational clarity. Likewise, the
research by Poister et.al (2010) which was carried out around local governments presented that
systematic strategic planning develops effectiveness of performance management systems and thus
provides meaningful improvements in outputs of public services. In the study the result is observed that
performance outcomes get improved as long as the managers’ trust against strategic planning increases.
In a study carried out in private sector by Andersen (2004) points out that in dynamic
environments where the strategic planning process is carried out flexibly, performance is at higher level
while it gets weaker under the conditions of formal and strict planning process.
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This finding reveals that planning has to be evaluated together with environmental and structural factors,
not context-freely. In an empirical study in healthcare sector Ginter et.al (2018) remarked that strategic
planning, especially in patient-centred services, contributes to performance development and creates
improvement in the fields like patient satisfaction, process productivity, clinical results. In this study, it
is emphasized that carrying out the planning processes including all stakeholders is the key of the
achievement.
Effect of ISO 9001 on business performance has been researched in both academic and applied
management literature intensely. The studies performed in this context show that effect of ISO 9001 on
performance may not be directly; usually occurs via mediators like process improvement, quality sense
and customer satisfaction. Benner and Veloso (2008), in the research they performed in production
sector, revealed that the organizations which have ISO 9001 certificate mange their processes more
effectively and have a cultural transformation related to quality management. However, the result has
been reached that effect of this transformation on financial performance reveals in the course of time
and in early years this effect is limited.
Sampaio et.al, (2009), in a survey study they performed in practitioner firms in Europe, revealed that
certification create positive results in terms of internal processes effectiveness and competitive
advantage in market. However, it is emphasized that to provide these advantages, royalty of senior
management and employees participation are indispensable.
In terms of Türkiye, Kömürcü et.al, (2014), in their study in which they examined quality
standards and models defined quality as “providing services in accordance with both scientific norms
and standards and expectations of individual.” In the study, they examined ISO 9001, Accreditation,
Magnet Standards, Deming, Malcom and EFQM models comparatively that are used for evaluating and
improving service quality of healthcare organizations and emphasized that these standards are effective
tools for determining strong and curable sides.
It is accepted that the relation between strategic planning and business performance displays a
contingent structure as well as a direct relation. At this point, there have been empirical findings about
the fact that institutional systems like ISO 9001 may act a regulatory (moderating) role on this relation.
Naveh and Marcus (2005) revealed that ISO 9001 applications strengthen the relation between strategic
planning and business performance. In their researches it has been determined that in ISO 9001
certificated organizations strategic objectives are integrated to operational processes easier and this
condition creates positive effects on performance. Besides, it is also emphasized that quality
management is adopted in these organizations at high level and processes. A study by Martínez-Costa
et.al, (2009) performed around production companies in Spain shows that ISO9001 is factor that
increased effect of strategic planning on performance.
It is remarked that in the organizations which have quality system, strategic objectives are
understood better, performance measurement tools work better and feedback mechanisms run more
effectively. Researches performed in healthcare sector also offer similar findings.
Van den Heuvel et.al, (2005) revealed that in hospitals in Netherlands ISO 9001 practices
increase the success of achieving objectives, strategic priorities like patient safety and patient-orientation
harmonised with processes. Saizarbitoria (2006) expressed that quality certificates contribute to
businesses as long as they are applied harmonically with strategic objectives, otherwise, it becomes a
symbolic application. In this regard, it has been revealed clearly that for actualising regulatory effect of
ISO 9001, quality system has to be integrated into strategic level.
In recent years, a comprehensive study has been conducted to assess the impact of the ISO 9001
standard on healthcare performance. Bounjerte et al. (2025) collected both interview and survey data at
a Moroccan hospital, demonstrating that the hospital unit improved through the implementation of the
ISO 9001 system proposal, performance evaluation, and staff perceptions. The study used a diagnostic
tool, McKinsey's 7S, as the seven-core assessment tool for organizational performance. Data were
collected through interviews and surveys at the hospital. The study revealed a positive perception of
QMS performance and its impact on patient satisfaction, continuity of care, and overall hospital
effectiveness. However, deficiencies in organizational factors such as internal communication and
personnel training were highlighted, identifying areas for future improvement.
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Similar results are found in other studies, such as Petryk et al. (2023). The study aimed to
analyze the ISO 9001:2015 Standard for the implementation of a QMS in medical services provided by
healthcare organizations and to identify patterns in performance to assess the effectiveness of the quality
management strategy. The study addresses the key factors for achieving a quality management strategy
through the implementation of a QMS to improve clinical indicators. The study examined the quality
management strategy based on a literature review and the analyzed standard. This strategy includes
leadership, adapting quality improvement initiatives, and defining the boundaries of administrative and
clinical policies. The study states that these approaches enable the integration of quality improvement
initiatives into a sustainable, organized system with continuous improvement. This study identified
positive effects of ISO 9001:2015 implementation in terms of improved clinical response times, reduced
errors, and improved patient-centered practices. These findings provide empirical evidence
demonstrating that quality systems directly link process performance and strategic objectives.
A semi-systematic literature review conducted by D'Alessandro et al. (2025) revealed the
effective implementation of ISO 9001 in healthcare, focusing on areas such as process flow, patient care
quality, accessibility, and sustainability. This study emphasizes the importance of combining quality
and strategy by emphasizing that digital technologies enhance ISO 9001 resolution and process
generalization. Similarly, Al Balushi (2024) found that organizational resilience is significantly
enhanced when the organization adopts a process-oriented format. This finding demonstrates that
supporting quality planning is crucial not only for quality but also for organizational resilience.
Finally, an empirical study by Bakhtiar et al. (2023) demonstrates that the publication of ISO
9001 practices is fully supported by culture and significantly improves performance. This study provides
an international example of the role of quality information in the integration of planning and quality
information.
There are also recent findings that implementing ISO 9001 practices solely for the purpose of
obtaining certification at a symbolic or ritual level provides limited performance benefits. For example,
a panel data analysis of publicly traded companies in Portugal by Neves, Reis, Reis, and Dias (2023)
revealed that the contribution of ISO 9001 certification to firm performance is not statistically significant
in some cases, and can even be negative. This suggests that quality management systems that are solely
document-based do not provide the expected functional benefits. Conversely, a survey study by
Milovanović, Paunović, and Casadesús (2023) examined the impact of ISO 9001 on employee and
customer satisfaction and found that symbolic practices lacking systematic and cultural cornerstones do
not lead to significant improvements in these areas. These results emphasize that for ISO 9001 to provide
strategic benefits, it must be implemented not only procedurally but also integrated into the
organizational culture.
4. Method
4.1. Research Model
In this study, effect of strategic planning on business performance has been examined; in this
relation, regulatory (moderating) role of ISO 9001 Quality Management System has been analysed.
Research model aims to reveal how having quality management system or not effect the relation between
strategic planning and business performance. Research model is presented in Figure 1. Three basic
variables take place in the model developed in this direction: as independent variable, as dependent
variable business performance and as regulatory (moderating) ISO 9001 certification state has been
used.
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Figure 1. Research Model
Fundamental assumption of the research is that effective strategic planning practices business
performance positively. Nonetheless, intensity and direction of the relation may vary according to
having a quality management system (ISO) 9001 or not.
ISO 9001 Quality Management System gains systematicity and consistency to organizational
management processes with the main principles like process approach, continuous improvement and
customer (patient) satisfaction; from this aspect may influence success of strategic management
practices and accordingly business performance (Benner and Veloso, 2008; Naveh and Marcus, 2005).
In this regard, two basis hypotheses will be tested within the framework of regulatory role of
ISO 9001.
H1: Strategic planning has a meaningful and positive effect on business performance.
H2: ISO 9001 quality management system organise the relation between Strategic planning and
business performance meaningly.
In the model, there is a perlocutionary relation turns to business performance from strategic
planning.
ISO 9001 is positioned as the regulatory variable that acts on this relation. In other saying,
research model has been grounded on the hypothesis that effect of strategic planning on business
performance in organizations that have ISO 9001 certificate is stronger against the ones that have not
the certificate.
4.2. Population and Sample
Population of this research consist of businesses that have managerial and administrative
personnel work in healthcare organizations act in İzmir province in the east of Türkiye. Research is
limited with the private hospitals, since health sector has a dynamic and hospitable structure in terms of
strategic planning and quality management system practices; within this scope, data have been obtained
from employees work in three different private healthcare organizations in İzmir province.
In the research, convenience sampling technique which is one of the purposeful sampling
methods has been used. This technique enables researches collecting data from easily accessible and
cooperative individuals. After getting necessary permissions from management of healthcare
organizations, survey form is applied to the employee work in related organizations and contribute to
strategic planning, quality management and performance assessment processes directly or indirectly.
While the participants comprise of senior and mid-level managers, also includes the qualified personnel
who have of decision making and reporting responsibility.
Within the scope of research, data is collected by face-to- face survey method between February
2025- March 2025. During this process totally 114 participants have been reached and whole of the
forms are admitted. Having limited number of participants made sampling frame more homogenous
qualitatively and increased reliability of analyses. Diversification of healthcare organization employees
as including ISO 9001 certificated or noncertificated businesses is important in terms of actualising
ISO 9001
Strategic
Planning
Business
Performance
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effect analysis. Therefore, it has been possible to make meaningful comparisons about both effect of
strategic planning practices on business performance and regulatory role of ISO 9001 in this relation.
As well as the population of the research is private healthcare organizations in İzmir; research
has been limited with three healthcare business because of data collecting process and organizational
access limit. Therefore, as well as the results of the study are limited in terms of generalization, selected
sampling group is estimated to be sample for similar businesses in healthcare sector. Since the sample
group comprise of people who have sufficient and proper information in accordance with the purpose
of the research, it is evaluated as a factor that increases validity of data obtained.
4.3. Data Collection Tools
In this study a structured survey form is used as data collection tool. Survey form consists of
two main sections. In the first section there have been questions regarding demographic and professional
features of the participants; in the second section there are scale items related to measuring perceptions
about strategic planning and business performance.
Through the demographic information form, in the first part of the survey information has
been collected related to participants’ age, gender, educational status, profession, experience duration,
positions in the organizations they work (manager/other) and whether the organization they work has
ISO 9001 Quality Management System certificate or not. This information has importance in terms of
determination of sampling and performing intergroup comparative analyses.
In order to measure strategic planning level, Strategic Planning Scale developed by Canbaz
and Yıldız (2014) is used. The scale which consists of four sub-dimensions, forms from 15 items.
These sub-dimensions are expressed as; functional planning, strategic decision making, external
environment activities and strategic analysis. Scale items are evaluated using 5 likert scale.
Participants answered the expressions with grades change between “1= Strongly Disagree” and “5=
Strongly Agree” This structure gives the opportunity to measure to what extend the participants join in
the strategic planning processes and how much they adopt these processes. As the result of validity
and reliability analyses, Cronbach Alpha co-efficient is found too high and in the pre analyses
performed within the scope of this study it is determined that internal consistency is sufficient.
In the study, data related to business performance have been collected using Business
Performance Scale based on subjective assessment base developed by Kuşluvan and Eren (2008). This
scale consist of 28 items addresses business performance with a multi-dimensioned approach.
Participants have evaluated their business performance comparing with similar nature of rival businesses
that act in the same sector. Within this scope, participants have been asked to answer in the direction of
the expression “Evaluate your last three years business performance in comparison to rival businesses
in your region”
Point scoring system used in the scale is specified as (1) Infinitely worse/low than rivals, (2)
Worse/lower than the rivals, (3) On parity with rivals, (4) Better/higher than rivals, (5) Infinitely
better/higher than rivals. This rating enables measuring the performance indicators like financial
indicators, operational effectiveness, service quality, patient satisfaction etc. based on perception of
participants.
4.4. Data Analysis Method
The purpose of this research is to examine the regulatory (moderator) role of ISO 9001 Quality
Management System in effect of strategic planning applications on business performance. Accordingly,
both direct effects and interactional effects have been considered for analysis of the relations among the
variables that take place in research model. During data analysis process, quantitative research
techniques have been used and analyses have been performed through IBM SPSS 25.0 and PROCESS
Macro for SPSS (v4.0) and the addition (Hayes, 2018).
Through this model, regulatory effect of ISO 9001 has been analysed in the relation between
the strategic planning that is an independent variable and business performance as a dependent variable.
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During the analysis process, it has been examined whether effect of strategic planning on business
performance differ meaningly by having ISO 9001 certificate (yes/no), or not.
Variables and abbreviations used in moderator analysis have been designated in Table 1. The
process used in moderator analysis can be summarized as: Independent variable (X): Strategic Planning,
Dependent variable (Y): Business performance, Moderator variable (M): Being ISO 9001 Certificate
Ownership (0= uncertificated, 1= certificated)
Table 1. Variables Used in the Study
Name of the Variable Type of Variable Abbreviation
Strategic Planning Independent Variable strplan
Business Performance Dependent Variable islperf
ISO 9001 Certificate
Ownership
Moderator Variable Iso
Within the scope of study, estimates have been performed using related multiple regression
analysis. Regression analysis is made by the aim of determining the relation which includes cause-
effect relationship among two or more variables and making prediction or foresight using this relation.
Econometric model which represents process of the study is expressed in Equation (1) as follows.
𝑖𝑠𝑙𝑝𝑒𝑟𝑓𝑖,𝑡 = 𝛼 + 𝛽1(𝑠𝑡𝑟𝑝𝑙𝑎𝑛𝑖,𝑡) + 𝛽2(𝑖𝑠𝑜𝑖,𝑡) + 𝑒𝑖,𝑡
Here;
α; fixed coefficient, β1 and β2 regression coefficients. ε; expresses the term error. Along with this
analysis, it is tested if effect of strategic planning on business performance is stronger or weaker in ISO
9001 certificated organizations against noncertified ones. In moderator analysis, considering the term
interaction (strplan*iso), it is determined whether or not there is a meaningful regulatory effect.
Within the scope of Hayes Process analyses, for statistical significance level of estimate
coefficients, in 95% confidence interval with bootstrap method taking 5.000 sample, bias-corrected
results have been obtained. Bootstrap approach provides obtaining more reliable results in small samples
increasing flexibility of hypotheses towards sampling distribution (Preacher & Hayes, 2004; Hayes,
2018).
5. Findings
5.1. Demographic Findings
Within the scope of study, mean values belong to participants’ qualifications like gender,
educational level, position and beside percentage distribution, age and professional experience durations
have been pointed in Table 2.
Table 2. Descriptive Statistics toward Participants
N % Ave
Gender Female 51 44,7%
Male 63 55,3%
Educational
Status
High School or Less 1 0,9%
High School and Equivalents 1 0,9%
Associate Degree 61 53,5%
Licence 51 44,7%
Postgraduate 0 0,0%
Position Executive 68 59,6%
Other 46 40,4%
Age 46,58
Professional Experience Duration 22,74
The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on Business Performance: A Research in
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When the gender distribution is examined, participants consist of 55,3% male (n=63) and 44,7%
female (n=51) individuals. This condition shows that number of male employees is a bit more than
female employees work in healthcare organizations within the scope of research. In distribution
according to educational level, it has been observed that a great majority of individuals take place in the
sample are associate degree (53,5%; n=61) and licence degree (44,7%; n=51). Rate of high school or
less graduated is pretty low (total 1,8%; n=2). There are no master level participants in the sample. This
distribution reveals that in healthcare sector, profession groups especially necessitate intermediate
education are at the forefront.
When the distribution is observed according to positions of the participants, it is identified that
59,6% of them are managers (n=68) and 40,4% are other employees (n=46). This condition provides
representing views of the individuals who act in decision making process much more in the analysis.
Age average of the participant has been found as 46,58. This value indicates that individuals
work in healthcare sector are from middle age group. Educational experience period is figured out as
average of 22,74 years. This finding indicates that the participants of the sample consist of experienced
employees and have been working in the sector for a long time period.
5.2. Reliability and Validity Analyses
To evaluate the measuring force of the data collection tools used in this study, primarily
reliability and validity analyses have been performed. Within the scope of reliability analysis,
Cronbach’s Alpha coefficient is considered, and the validity analysis Confirmatory Factor Analysis
(CFA) has been used. The goodness of fit indexes obtained as a result of CFA have been evaluated by
the purpose of testing structural validity of scales.
Information related to average and standard deviation Cronbach’s Alpha Reliability Coefficient
values of scales are presented in Table 3. Strategic Planning Scale and Cronbach’s Alpha Reliability
Coefficient which are the internal consistency coefficients are calculated as 88 and 92. These values
have been pretty over the threshold of 70 value suggested by Nunnally (1978) and it show that both two
scales are reliable at high level. These findings reveal that the answers given for the both scale items by
participants are consistent and the scales can be used reliably within the context of research.
Table 3. Average Standard Deviation Related to Scales and Reliability Coefficient
Scales Ave S.S. Cronbach’s Alpha Reliability Co-efficient
Strategic Planning Scale 4.36 .33 .88
Business Performance Scale 4.13 .39 .92
To test the structural validity of scales, Confirmatory Factor Analysis (CFA) has been applied
and goodness of fit indexes obtained in consequence of analysis has been evaluated. Among the basic
goodness of fit indexes CMIN/DF, GFI, AGFI, CFI, NFI, TLI and RMSEA take place. Admissibility
levels related to these indexes are summarized as follows:
Criterions for best fit: CMIN/DF ≤ 3, GFI ≥ .90, AGFI ≥ .85, CFI ≥ .90, NFI ≥ .95, TLI ≥ .90, RMSEA
≤ .05
Criterions for agreeable fit: CMIN/DF ≤ 5, GFI ≥ .85, AGFI ≥ .80, NFI ≥ .90, RMSEA ≤ .08
CFA results evaluated in the base of criterions mentioned before have been displayed in Table 4.
Table 4. Goodness of Fit Scores Related to Scales
Scale CMIN/DF GFI AGFI CFI NFI TLI RMSEA
Strategic Planning Scale 2,6 .89 .86 .94 .97 .91 .04
Business Performance Scale 1,8 .92 .93 .94 .95 .97 .02
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CMIN/DF value for Strategic Planning Scale has been calculated as 2.6 and takes place in
acceptable range. While GFI (.89) and AGFI (.86) values produce results close to good fit; the other
indexes like CFI (.94), NFI (.97), TLI (.91) meet the good fit criterions. RMSEA value is .04 and shows
that it is pretty successful in terms of model match. Likewise, CMIN/DF value is indicated as 1.8 for
Business Performance Scale and it shows that there is a good model match. All of the values like GFI
(.92), AGFI (.93), CFI (.94), NFI (.95), TLI (.97) are over the limits and RMSEA is .02 as low as
requested. These results present that Business Performance Scale offers a pretty strong structure in terms
of validity.
5.3. Analysis Results
Results obtained within the scope of study have been presented in Table 5. According to the
resultants of the analysis, general model has been found significant (F (3,110) = 6.15, p = .0289).
Explanatory level of the model is quite high (R² = .7465), and it expresses that strategic planning (strpln),
ISO 9001 ownership and the term interaction (strplan x ISO) explain 75% of the change in business
performance all together.
Table 5. Estimate Results
Dependent Variable: business performance
R R2 MSE F df1 df2 p
0,8640 0,7465 1,1124 6,1509 3 110 0,0289
Model Co-
efficient se T p LLCI ULCI
𝜶
4,3336 3,1548 5,1829 0,000 1,0125 5,8234
𝜷𝟏
(strplan) 0,7421 0,2210 -0,0093 0,0026 -0,8215 0,8424
𝜷𝟐
(iso) 0,0897 0,2210 0,0913 0,0016 -0,2145 0,5142
𝜷𝟑
int1
(strplan*iso)
1,012 0,1245 0,1245 0,0002 0,1452 1,2314
According to the obtained findings, strategic planning variable (β1 = .7421, p = .0026) has a
positive and meaningful effect on business performance. This finding indicates that strategic planning
applications have an additive effect on business performance. As well as direct effect of ISO 9001 on
business performance seems meaningful (p = .0016), as an interactivity term SP x ISO product (β3 =
1.012, p = .0002) is strategically meaningful. This result reveals that ISO 9001 certification changes the
effect of strategic planning on business performance at significance level, namely it has a moderatorship
effect.
The differentiation of the relation between strategic planning levels and business according to
of ISO 9001 certificate ownership condition has been displayed in Figure 2. In the businesses which has
not ISO 9001, as long as strategic planning increases, a limited increase is observed in business
performance (blue dashed line), in ISO 9001 certificate owner organizations effect of strategic planning
on business performance is shown up more powerfully (green straight line). This interaction has been
supported by statistically significant interaction coefficient (b = 1.012, p < .001) which is obtained in
moderator analysis
The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on Business Performance: A Research in
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b
Figure 2. Role of ISO 9001 in Effect of Strategic Planning on Business performance
This condition shows that ISO 9001 certification shapes the relation between strategic planning
and business performance significantly. In other words, contribution of strategic planning activities to
business performance emerges more specifically in organizations have ISO 9001 quality management
system.
This finding indicates that quality management systems do not only standardise the processes,
but also provide a stronger contribute to business performance increasing effectiveness of the strategic
planning.
The most critical finding in the model indicates that the relation between strategic planning and
business performance change depending on ISO 9001 ownership. Meaningfulness of the term
interaction (p = .0002) and as a result of this interaction, 1% improvement in R² value of the model (ΔR²
= .0102) clearly reveals that ISO 9001has a regulatory role on this relation. In this regard, effect of
strategic planning on business performance is stronger in organizations that have ISO 9001 certificate.
This condition reveals that quality management system applications support achieving strategic
objectives and thanks to this increase can be provided in performance indicators.
5. Conclusion and Discussion
Strategic planning is a critical management tool for the businesses in terms of providing long-
term successes, complying with environmental changes and reaching organizational objectives
effectively. From this aspect, it is clear that in the areas where intense competition, complicated
regulations and high service expectations take place like healthcare sector strategic planning becomes
more significant.
On the other hand, quality management systems are shown up as important structures form
performances of businesses within the frame of standardization of organizational processes and
continuous improvement principles. In this regard, the issue how the relation between strategic planning
and business performance interact with quality management applications represents a significant spacing
theoretically and practically.
Significance of the findings achieved in this study is remarkable in recognition of dealing this
spacing with specific to healthcare sector and empirical data. Research results assert that in healthcare
businesses strategic planning is directly associated with performance outputs and this relation is
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regulated by ISO 9001 Quality Management System. This statement is important since quality systems
are not only processual but also play a transformative role in managerial processes.
While analysis findings affirm the increasing effect of strategic planning in private businesses
in healthcare sector, also indicate that ISO 9001 quality management system reinforces this effect
significantly. This condition assert that ISO 9001 can be evaluated as not only a certification process of
quality standards but also as a tool that eases integration to strategic management.
In summary, these findings reveal that ISO 9001 quality management system applications
moderate effects of strategic planning efforts on business performance positively, so it plays a regulatory
role. This finding supports the previous studies that point out the additive effect of strategic planning on
business performance as a managerial tool. For example, Bryson (2018), remarks that strategic planning
causes improvements in performance outputs increasing managerial focus in public and private sector
organizations. Likewise, Al Hijaa (2023) also expresses that strategic planning in healthcare sector
creates positive effects on the performance indicators like patient satisfaction and service quality.
Findings obtained in this study are accord with mentioned literature and besides, they emphasize the
significance of planning much more in an area in which service intensity is at high level like healthcare
sector.
In recent years, the healthcare management literature has increasingly examined the role of
strategic planning and quality systems in organizational success. For example, Milovanović, Paunović,
and Casadesús (2023) noted that ISO 9001 is particularly effective on soft performance indicators such
as patient and employee satisfaction. Similarly, Neves et al. (2023) demonstrated that implementing
quality management systems not only procedurally but also integrated with the strategic level improves
performance. These current findings support the implications of this study focused on the healthcare
sector and offer theoretical contributions for organizational practices.
It has been revealed that ISO 9001 certification regulates the relation between strategic planning
and business performance. In other words, in the organizations which have quality management system
effect of strategic planning on performance has been perceived more vigorously. This finding show that
ISO 9001 does not only provide specific quality standards in businesses, also turns the strategic thought
into an institutional reflex. This result supports the studies of researches like Psomas and Jaca (2016)
and Heras-Saizarbitoria and Boiral (2013) indicate that integration of quality management systems to
strategic management has positive effects on business productivity and performance. However, what
makes this study original is to deal with quality systems as a transformative function for the effect of
strategic planning on business performance. Whereas quality management is evaluated within the
context of its direct effect on performance, this research positions quality management as a regulatory
(moderator) variable and contributes to literature by this side.
Another important implication is that ISO 9001 certification forms a configurator base for
strategic management applications in healthcare services. Process approach, continuous improvement
principle and customer (patient) orientation emphasis which have been brought by ISO 9001 makes it
possible to apply the strategic planning more effectively. Findings obtained within this framework
coincide with observations of the researches like Wilkinson et al. (1998) and Tari (2005) about the
positive relation between quality management and managerial effectiveness. Nevertheless, the point
separates this research from the literature shows empirically that the mentioned effectiveness is not only
structural but also creates a quality climate which reflects on strategic decisions process.
However, although the moderator effect was statistically significant, the effect size (ΔR² =
0.0102) was quite limited. This suggests that the practical impact of ISO 9001 on the strategic planning-
performance relationship, despite its statistical significance, may not be observably strong in practice.
In other words, the moderating role of the quality management system in this relationship is significant
but weak. Therefore, the results should be interpreted with caution in managerial practices, and it is
recommended that organizational factors (leadership, employee participation, etc.) that may enhance
this effect be investigated.
Moderator analysis which is used in the study as an empirical method carries value since it
points that strategic planning- performance relation is not only direct but also shaped by contextual
factors. Therefore, a methodologic proposal has also been offered for the future researches about
The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on Business Performance: A Research in
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1521
necessity of discussing the relation between strategic management and quality management with more
integrated approaches.
The study results offer implications in healthcare sector-specific context. Health businesses are
pretty delicate areas in terms of the performance indicators like patient satisfaction, service quality and
process reliability. In this regard, integrating strategic planning processes with quality management
principles does not only increase internal productivities, also contributes to developing patient
orientation, continuity and service quality. Therefore, adopting the international standards like ISO 9001
acts a facilitator role for healthcare organizations to reach the strategic objectives more effectively.
The study has some limitations. The research is limited with three private healthcare
organizations take place in İzmir province and sample size is relatively low. Besides, measurements
used in the study are based on subjective declarations and may bring up the issues like respondent bias.
For future researches mixed research designs that include various healthcare sector types (public,
university hospitals etc.) and integrate both qualitative and quantitative data collection tools.
Furthermore, the business performance scale used in this study relies on participants' own
perceptions, which are based on subjective judgments. This may lead to responses lacking objectivity
and being influenced by participants' personal attitudes, experiences, or levels of organizational
commitment. In particular, the reliance on subjective interpretations of internal and external
organizational comparisons increases the risk of measurement bias. Therefore, mixed assessment
methods supplemented with objective performance indicators (e.g., patient waiting times, financial
indicators, or satisfaction scores) are recommended for future studies.
This study reveals positive effect of strategic planning on business performance and it points
that this relation may change significantly according to ISO 9001 quality management system
ownership. Findings offer significant managerial deductions towards businesses act in healthcare sector.
To get competitive advantage and developing service quality, integrating strategic planning processes
with systematic quality management practices is critically important for the organizations. Especially
the potential of international quality standards like ISO 9001 for increasing the effectiveness of strategic
planning reveals that this kind of systems have to be evaluated not only as a certification tool but also
as a management tools.
This study offers significant practical implications for hospital managers and decision-makers
operating in the healthcare sector. First, it demonstrates that the ISO 9001 quality management system
should be integrated into the strategic planning process, not merely as a formal certification process.
Associating process-oriented approaches, performance measurement criteria and the continuous
improvement cycle developed within the scope of ISO 9001 with strategic goals can provide tangible
improvements in both employee productivity and patient satisfaction.
Furthermore, the standard's support for corporate communication, information sharing, and risk
management processes contributes to healthcare institutions' greater resilience and flexibility,
particularly during times of crisis. Therefore, managers should consider ISO 9001 not merely as a means
of complying with external audits, but as a strategic management tool for achieving sustainable
performance improvements and competitive advantage.
Given the limitations of the study, some recommendations for future research can be developed.
First, it would be beneficial to use mixed-method designs (qualitative interviews, focus groups, etc., in
addition to quantitative analyses) to gain a more comprehensive understanding of the impact of ISO
9001 on strategic planning and business performance.
Furthermore, incorporating objective performance indicators such as patient waiting times,
financial statements, satisfaction scores, and quality accreditation scores into the analysis, rather than
relying solely on subjective survey data, will increase the reliability of the results. Finally, comparative
studies conducted with samples from different sectors will reveal the context-specific impacts of ISO
9001, contributing to the literature and enabling more generalizable results for practitioners.
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1522
Değerlendirme/Evaluation:
Çift Taraflı Kör Hakemlik Sistemi
Double Blind Refereeing System
Etik Beyan Metni/ Ethics Declaration Text:
Çalışmanın hazırlanma sürecinde bilimsel ve etik ilkelere uyulduğu ve yararlanılan tüm çalışmaların kaynakçada
belirtildiği beyan olunur.
It is hereby declared that scientific and ethical principles were adhered to during the preparation of this study
and that all studies used are cited in the references.
Etik Bildirim/Ethics Notification: [email protected]
Yapay Zekâ Kullanımı /Use of Artificial Intelligence:
Bu çalışmanın hazırlanma sürecinde yapay zekâ tabanlı herhangi bir araç veya uygulama kullanılmamıştır.
Çalışmanın tüm içeriği, yazar(lar) tarafından bilimsel araştırma yöntemleri ve akademik etik ilkelere uygun şekilde
üretilmiştir.
No artificial intelligence-based tools or applications were used in the preparation of this study. All content of the
study was produced by the author(s) in accordance with scientific research methods and academic ethical
principles.
Çıkar Çatışması Beyanı/ Declaration of conflict of interest:
Bu çalışmada herhangi bir potansiyel çıkar çatışması bulunmamaktadır.
There is no potential conflict of interest in this study.
The Regulatory Role of Iso 9001 In the Effect of Strategic Planning on Business Performance: A Research in
Health Care Sector
1523
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