Volume 12 - Issue 68
/ August 2023
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DOI: https://doi.org/10.34069/AI/2023.68.08.31
How to Cite:
Petryk, S., Andrieiev, I., Tishko, D., Kurbanov, A., & Yunger, V. (2023). The effectiveness of quality management strategies in
health care organizations: an analysis of quality standards implementation and clinical performance improvement. Amazonia
Investiga, 12(68), 333-345. https://doi.org/10.34069/AI/2023.68.08.31
The effectiveness of quality management strategies in health care
organizations: an analysis of quality standards implementation and
clinical performance improvement
Ефективність стратегій управління якістю в організаціях охорони здоров'я: аналіз
впровадження стандартів якості та покращення клінічних показників
Received: June 8, 2023 Accepted: August 18, 2023
Written by:
Serhii Petryk1
https://orcid.org/0000-0001-9942-1937
Ievgenii Andrieiev2
https://orcid.org/0000-0002-0727-8166
Dmytro Tishko3
https://orcid.org/0000-0003-4271-0812
Anton Kurbanov4
https://orcid.org/0000-0002-6632-9525
Vitaliy Yunger5
https://orcid.org/0000-0003-0403-1624
Abstract
Quality management strategies in healthcare
institutions require an increasingly refined
quality management system. This study aims to
analyze the ISO 9001:2015 Standard for the
implementation of a quality management system
in the field of medical services provided by
healthcare facilities, as well as to determine
patterns during performance to assess the
effectiveness of the quality management
strategy. The article discusses key factors for
achieving the quality management strategy
through the implementation of a quality
management system to improve clinical
indicators. This system, according to the
requirements of the ISO 9001:2015 Standard,
ensures quality service provision.
A cyclical sequence of actions is used to analyze
quality management system implementation. It is
applied to quality service processes in healthcare
organizations and reflects some key aspects
1
Department of National Security, Public Administration and Administration, Zhytomyr Polytechnic State University, Zhytomyr,
Ukraine.
2
Department of National Security, Public Administration and Administration, Zhytomyr Polytechnic State University, Zhytomyr,
Ukraine.
3
Department of National Security, Public Administration and Management, Faculty of Public Administration, Law and International
Relations, Zhytomyr Polytechnic State University, Zhytomyr, Ukraine.
4
Department of Surgery, Bogomolets National Medical University, Kyiv, Ukraine.
5
Department of National Security, Public Administration and Administration, Zhytomyr Polytechnic State University, Zhytomyr,
Ukraine.
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(planning, execution, activities, and verification
of all relevant processes as described in the ISO
9001:2015 Standard). The authors have
examined the quality management strategy based
on the literature review and the analyzed
standard. This strategy includes leadership,
adapting quality improvement initiatives, setting
the boundaries of managerial and clinical
policies. All the above allow the integration of
quality improvement initiatives into a
sustainable, organized system with continuous
enhancement.
Keywords: improvement, ISO 9001, personnel
competence, quality management strategy,
quality management system.
Introduction
In today's world, many healthcare organizations
provide services and care for their patients.
Therefore, they are faced with the challenge of
ensuring that patients receive high-quality and
efficient healthcare services. The first step in
achieving this goal is to develop and implement
quality management standards and continuously
improve clinical performance. It is an essential
aspect of the reliability and effectiveness of
healthcare services (Donev, 2022). The
implementation of such standards helps to ensure
the high quality of treatment and nursing during
patient care. It also reduces the risk of
complications and improves the effectiveness of
treatment and prevention (Hibbert et al., 2021).
A quality management strategy's effectiveness in
healthcare organizations significantly impacts
treatment outcomes and patient satisfaction
(Haleem et al., 2022). For this purpose, there is a
list of factors that influence the determination of
the strategies' effectiveness:
− leadership (successful and trouble-free
implementation of a quality management
strategy requires strong leadership in
organizations, where managers must
embrace the concept of quality and actively
support its performance) (ISO, 2015);
− employee involvement (effective quality
management strategies require the active
participation of all organization's
employees, which may include staff
training, seminars, and participation in
decision-making);
− use of evidence-based medicine (effective
strategies should be evidence-based, using
the latest data and scientific
recommendations to ensure that services are
delivered at the time of service at the best
possible time);
− monitoring, surveillance, and assessment
(the existence of management systems that
provide monitoring, surveillance, and
assessment processes that allow the
organization to obtain unbiased data on the
effectiveness of its strategies, as well as to
identify problem situations and make
appropriate adjustments to prevent them)
(ISO, 2015);
− implementation of innovations (effective
strategies of the quality management system
are constantly updated and improved, and
the use of the latest technologies, modern
methods, and approaches can improve
treatment outcomes and contribute to the
improvement of clinical performances);
− patient-centricity (effective quality
management system strategies are focused
on meeting the patient's needs, where the key
aspect of management is to provide
affordable, effective, and empirical
healthcare).
The aforementioned factors can ensure the
effectiveness of the quality management system
strategy. These strategies can be implemented in
healthcare facilities and organizations while
providing patients with high-quality services
(Leggat & Balding, 2018).
The implementation of a quality management
system (QMS) and the improvement of clinical
practice are key tasks in the healthcare field. This
process typically involves the development and
implementation of standards, protocols, and
guidelines that define best practices, procedures,
and treatment methods (Hibbert et al., 2021).
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One of the key aspects of QMS implementation
is to ensure patient safety. The development of
protocols and procedures accompanies it to
ensure safe medical care and prevent errors and
complications. Such protocols and procedures
include:
− patient identification checks before
performing necessary procedures;
− use of safe medicines;
− implementation of infection control
procedures, etc (World Health Organization,
2021).
Furthermore, QMS implementation helps
improve clinical outcomes. For instance,
implementing treatment protocols for specific
diseases can enhance treatment outcomes and
reduce mortality (Yabroff et al, 2019).
Developing standards and improving clinical
characteristics also ensures consistent quality of
service provision to patients regardless of their
social status or place of residence (Brouwers et
al., 2021). QMS implementation, along with
improved clinical characteristics, is an ongoing
process that involves continuous updates of
protocols and procedures, as well as training of
medical personnel. It helps develop and enhance
healthcare practices to ensure the highest level of
service (Darr et al, 2021).
Modern organizations in the healthcare sector are
classified based on ownership and management
models. They can be either private or public,
depending on the provision of public services.
Public services involve various measures to serve
and meet the needs of citizens (clients, patients)
for service provision (Zhang et al., 2019).
Healthcare organizations within public entities
are obligated to provide effective services aimed
at improving health and addressing the
population's health dynamics in each country
worldwide (Kristiningrum et al., 2021).
Governments worldwide strive to find models for
their healthcare systems that ensure patient
service quality. Over the past two decades,
various external quality control mechanisms
have been introduced and tested in many
European countries. These mechanisms range
from hospital accreditation to compliance with
ISO standards, as defined by European research
projects on mechanisms of external expert
assessment8. First, the quality definition models
are used to analyze the indicators related to the
quality assurance requirements in the hospital.
After that, the opportunities for improvement are
identified (Moldovan & Bataga, 2022).
The standards are used to improve and enhance
the quality management strategy, based on which
a quality management system (QMS) can be
implemented (Eisner & Patel, 2017). One such
quality standard is "Quality Management
Systems – Requirements" ISO 9001. This
standard enables organizations, regardless of the
industry in which they exist, to properly
implement a quality management system (Gupta
& Rokade, 2016). Over the past ten years, this
standard has attracted attention in the healthcare
industry for the provision of medical services. It
defines a value system that combines a set of
criteria for quality management. For example,
they include organization management,
compliance, procedural management, etc
(Petkovska & Gjorgjeska, 2014).
The following factors may be relevant problems
in the implementation and enforcement of quality
standards in healthcare organizations:
− insufficient knowledge and incompetence of
medical staff. healthcare professionals may
not have a sufficient understanding of
quality standards and their importance,
which affects their direct implementation;
− insufficient funding and limited resources.
implementation of quality standards requires
large expenditures on equipment, staff
training, and implementation of new
systems. insufficient funding and resources
can make this process difficult and, in some
cases, impossible;
− insufficient use of technology when old and
outdated systems, equipment, and devices
may make it impossible to comply with the
methodology of performance per quality
standards.
The effectiveness of the quality management
strategy in healthcare facilities may depend on
numerous factors. These factors should be
determined by the quality management standard
in compliance with the requirements for the
implementation of the quality management
system. A mismatch or non-compliance with the
requirements in each standard's clauses may
trigger a chain failure in the quality management
system. For example, when engaging
maintenance personnel to perform work at the
planning stage, problems may arise due to the
incompetence of maintenance personnel. This
may have a negative impact on the collection,
receipt, and processing of data for analysis,
affecting the organization's performance. In
addition, incompetence can significantly affect
continuous improvement and jeopardize the
improvement of patient care methods.
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The planning, development, and implementation
of the QMS may also result in inconsistencies
with subsequent developments that may limit the
needs for patient care. Therefore, all possible
risks and their opportunities should be
considered in advance during planning and
implementation. Therefore, it reduces the
possibility of undesirable consequences and thus
prevents damage to the interests of the
organization.
Literature Review
The work with standards is an effective method
of continuous improvement of production
systems using helpful tools for maintaining
documentation of the most efficient ways of
creating a product or service. Working with
standards helps maintain quality, ensures
efficient operations, and guarantees proper use of
tools and equipment. It also helps train
employees to identify and eliminate non-value-
added actions. Therefore, such standard work is
a diagnostic tool that identifies issues and
contributes to continuous improvement (Patkal &
Anasane, 2022).
There are numerous concerns about improving
the quality and safety of patient care in healthcare
facilities. For this reason, Quality Management
Systems (QMS) are widely applied to develop
effective strategies for enhancing service
provision (Gargasas, Samuolaitis & Mūgienė,
2019). One common strategy is a system
described in the International Organization for
Standardization (ISO) Standard ISO 9001. The
ISO 9001 QMS standards family is used by
organizations aiming to enhance the quality of
their products or services (Betlloch-Mas et al.,
2019). This standard represents an international
agreement on quality management. It ensures
that workers consistently provide products and
services that meet customer requirements,
continuously improve organizational
performance, and increase customer satisfaction
(Heydari, Lai & Xiaohu, 2019). However, the
research by Kristiningrum (2021) analyzed that
inefficient medical centers and organizations still
exist today, even with the implementation of ISO
9001 QMS.
A quality system is defined as an organizational
structure that manages quality or as a coordinated
working structure across the entire company,
documented in effective, integrated technical and
managerial procedures to guide coordinated
actions of workforce, machinery, and
information to ensure customer satisfaction with
quality and operational efficiency (Kumar, Maiti
& Gunasekaran, 2018).
The components of a quality system to achieve
high-quality assistance can be found in separate
documents, such as "National Standards for
Safety and Quality in Healthcare." This
document covers a list of QMS components:
− policy development and review;
− compliance requirements;
− risk management;
− clinical documentation;
− accreditation and scope of practice;
− training and development;
− healthcare rights charter;
− confidentiality.
In the research by Leggat & Balding (2018), a
concise overview is provided where the National
Health Service (NHS) proposes four QMS
components:
− strategy;
− capabilities and culture;
− processes and structures;
− assessment.
The implementation of a surveillance system and
policies contributes to overall problem-solving
and prevention in over 50% of cases within
healthcare organizations. It not only results in
cost savings for the organization but also, on a
global scale, reduces variation in the delivery of
medical services during patient care. In the study
by Petkovska & Gjorgjeska (2014), the expected
benefits of implementing the system in the
Republic of North Macedonia healthcare sector
are explored. These benefits are related to the
establishment of an essential basis for obtaining
all necessary resources, as well as reducing costs
by minimizing inadequate personnel in clearly
defined departments.
Future accreditation processes can be
implemented in a much shorter time frame,
especially with established communication and
collaboration between departments. Financial
savings are evident in healthcare organizations
that have implemented an ISO 9001 quality
system. This redirection of resources allows for
the development and implementation of new
treatment technologies that may lead to QMS
improvements.
Ultimately, standards are designed to improve
outcomes, and the primary logic of the QMS
application is to:
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− improve organizational performance and
create a process-dependent system;
− improving systems and microsystems
through process dependency;
− improving the system and microsystem to
improve services;
− increasing service resilience and
effectiveness (Darr et al., 2021).
Therefore, a thorough analysis of the standard
QMS implementation requirements is necessary
to assess the risks and potential occurrences
during the servicing of healthcare facilities, as
well as to analyze methods and measures for their
prevention.
The study aims to conduct an analysis of the
ISO 9001:2015 Standard for the implementation
of a quality management system in the healthcare
sector, as well as to identify patterns during the
implementation process to assess the
effectiveness of the quality management
strategy.
The following tasks need to be accomplished to
achieve this goal:
− to conduct a literature review on the use of
international standards in healthcare
organizations and identify factors that
influence the adoption of new standards.
− to analyze the ISO 9001:2015 Standard
("Quality management systems –
Requirements") to determine the
effectiveness of the implementation strategy
in the healthcare sector.
− to analyze key indicators and factors
contributing to healthcare facilities' quality
service provision.
Methodology
International Standard ISO 9001:2015
"Quality management systems –
Requirements"
ISO 9001:2015 Standard is used for developing
Quality Management Systems (QMS) in
healthcare organizations. It can be utilized to
enhance processes, organization, and patient
satisfaction. This standard aims to improve
clinical indicators within healthcare
organizations by establishing a QMS focused on
processes, organization, and improvement (ISO,
2015). Despite having multiple versions, the
author has analyzed the 2015 version.
ISO 9001 Standard imposes requirements on
QMS under the following conditions:
1. The organization must demonstrate the
ability to consistently provide services and
products that meet customer needs and
requirements (including legislative and
regulatory requirements).
2. The organization is oriented towards
increasing customer satisfaction, which is
explained by the effectiveness of the
system's application, specifically through
system improvement processes and ensuring
compliance with customer requirements
based on legislative and regulated
requirements.
The set of requirements of this standard are
common. They are intended to be applied in any
field of activity, regardless of key parameters
(type, size, etc.).
The following factors need to be considered to
implement QMS standards:
− to define the object (enterprise, company)
and the service area (pharmaceutical and
medical sectors, metallurgical and
engineering sectors, etc.) for QMS
implementation.
− to define the organization's environment and
analyze needs (identify priorities and areas).
− to familiarize oneself with the requirements
of international standards (e.g., ISO
15189:2022).
− to adapt standards according to the
organization's interests.
− to conduct planning and involve personnel in
team collaboration, etc.
− to collect and analyze data for result
compilation.
− to determine more suitable monitoring and
observation systems to integrate into QMS.
− to conduct internal audits and certification.
− to implement a continuous improvement
process.
Results and Discussion
An interdependent cycle of sequential actions
applied to the processes in the field of service
quality in healthcare organizations is used to
analyze the QMS standards implementation. This
cycle reflects key aspects of QMS and
demonstrates the Plan-Do-Check-Act circle
(PDCA) of all relevant processes described in the
ISO 9001:2015 Standard. Figure 1 depicts the
PDCA cycle, which is explained as follows:
− plan (defining the system's objectives
involving its processes and necessary
resources to achieve planned outcomes
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during service provision, as well as
identifying risks and opportunities of their
occurrence).
− do (implementing the planned, defined
objectives and developing minimization of
risk occurrences and their avoidance).
− check (conducting monitoring and
observation systems with process
measurements to obtain service performance
and adequate service provision, followed by
reporting).
− act (taking safety measures based on
corrective actions to improve effectiveness).
The PDCA cycle describes internal
organizational factors (planning, improvement,
QMS maintenance, and effectiveness evaluation)
according to the organization's needs and its
position in the environment, stakeholder
requirements, and their needs. However,
stakeholder satisfaction and the provision of
services with resulting products significantly
impact QMS, affecting performance and
efficiency.
Figure 1. Plan - Do - Check - Act cycle for QMS implementation.
Source: ISO 9001:2015 "Quality management systems – Requirements".
Now, we will take a closer look at the QMS. It is
considered for a healthcare organization, and the
requirements for its implementation as described
by the ISO 9001:2015 Standard. The
improvement, development, and implementation
of QMS standards are considered in the Table 1.
The table describes the operations of the standard
for a more detailed study and analysis. The table
contains the main operations.
Table 1.
Requirements of the ISO 9001:2015 clauses for analyzing the implementation of standards in a healthcare
organization.
№
Requirements of standard
clauses
Explanation
1.
Analysis of needs
The beginning of the analysis of the healthcare organization's needs.
Identification of priorities and areas for improvement.
2.
Familiarization with international
standards
Research of international ISO standards, such as ISO 9001:2015, ISO
15189:2012, and other standards related to QMS and medical
laboratories, equipment, etc.
3.
Adapting the standards to the
organization's needs
Consideration of specific organizational features and adaptation of
standards to the needs of the medical institution.
4.
Implementation planning
Development of a detailed plan for the implementation of healthcare
quality standards, which should define roles and responsibilities,
performers, and deadlines.
5.
Personnel involvement
Designation of responsible persons for each aspect of the
implementation and staff training on the new procedures as required.
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6.
Data analysis based on the
collected documentation
Collection of internal data on processes and work performance to
assess the current state and identify existing problems in the quality
system.
7.
Implementation and monitoring
Implementation of new quality control procedures and mechanisms, as
well as monitoring their effectiveness and making the necessary
changes if problems are identified.
8.
Audit and certification
The planning of internal audits to verify compliance with standards, as
well as external audit certification, if necessary.
9.
Continuous improvement
Implementation of a continuous improvement process based on the
results of audits and feedback from staff and patients.
Source: compiled by the authors.
Analysis and understanding of stakeholders'
needs and expectations
The organization's task is to identify external and
internal factors relevant to its purpose and
strategic direction with the impact and ability to
achieve the intended result. Therefore, a
company should monitor and analyze
information from external and internal factors.
Any organization in a particular service sector
with the provision of services should identify the
stakeholders that can be involved in the QMS
from a reasonable point of view, as well as
regulate the requirements of the stakeholders
involved in the QMS.
Adaptation of standards to a company's needs
The healthcare organization adapts the QMS
standards by establishing the service area based
on ownership and considering internal and
external factors, stakeholder requirements, and
the products and services. To meet the ISO 9001
quality control standard, the organization must
ensure all requirements are met without fail. In
addition, this service considers the applicable
limits in its defined service area. It is essential to
properly regulate and validate all information
regarding the scope of application and service. It
should be noted that within the application area,
all types of covered products and services must
be described with relevant documentation and
justification, following the standard's
requirements.
Furthermore, the organization must consistently
maintain and improve the documented
information required for process functioning.
Keeping records ensures confidence in executing
planned processes during servicing.
Implementation planning
Planning involves actions related to risks and
opportunities identified and considered by the
Quality Management System (QMS) to achieve
the intended outcome. These actions also aim to
prevent undesirable (sudden) aspects and reduce
their occurrences. In addition, they are aimed at
increasing desirable effects that can lead to QMS
improvement. The task of a healthcare
organization is to plan activities regarding risks
and opportunities based on the integration and
implementation of preventive actions according
to QMS requirements.
The primary goal of healthcare organizations
during planning is to define quality objectives
and plan actions for their effective achievement.
An institution establishes quality goals involving
relevant departments for the execution of
medical operations and processes directly
considered by QMS. Quality goals should be
aligned with policies, applied requirements,
updated, applicable to service conformity for
patient satisfaction, and covered by monitoring
and safety systems.
An institution aims to identify the necessary
resources and responsible people, as well as set
deadlines for completion with an assessment of
the results to ensure quality and effective
planning to achieve the service quality goals. In
the case of planning with changes, the
organization addresses the need for changes to
QMS if modifications need to be executed as
planned. During these changes, there are
considered consequences of designated shifts,
QMS integrity, delegation of authority, and
responsibilities.
Personnel involvement
The medical institution's personnel in the
healthcare organization should possess
proficiency and expertise. These efforts evaluate
the QMS's effectiveness. Achieving this requires
the organization to ascertain a person's
competency before assigning tasks. This
involves assessing their qualifications,
conducting exams, reviewing prior work
experience, and providing orientation training,
among other measures. The competence and
knowledge of medical professionals involve their
ability to apply knowledge for the professional
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execution of their duties in delivering quality
services. Knowledge in the quality field of the
organization is driven by management policies,
objectives, personal contributions to improve
system performance, and enhancements to
performance indicators while also considering
consequences for non-compliance with QMS
requirements.
Competency can encompass various aspects of
medical practice, such as:
− medical personnel should possess sufficient
knowledge in their acquired specialty,
including anatomy, physiology, pathology,
and the treatment of various diseases.
− they should also possess the necessary skills
to perform various procedures and
manipulations, such as conducting
examinations, administering drugs and
medications intravenously, and providing
emergency assistance.
Communication in healthcare is essential for
maintaining effective telecommunication with
patients. Healthcare professionals must provide
clear explanations regarding procedures and
potential consequences, as well as instructions on
medication acquisition.
In critical cases, the organization should consider
retraining medical personnel to guarantee their
knowledge and practical skills align with
theoretical methodologies and practical
implementation. Some measures aim to conduct
training under the supervision of mentors,
transfer personnel to other positions, and involve
competent people in contract negotiation.
Data analysis based on the collected
documentation
The QMS of a healthcare organization covers a
set of recorded and regulated data prescribed by
the 9001:2015 Standard. For this purpose, an up-
to-date map of recorded information is created.
An institution ensures that the documentation is
described correctly and identified with its name,
date, and expiration date, initials, number, seal
with signature, and depending on the format and
media. Documented information is usually
controlled to ensure its availability and
expiration date, its confidentiality, proper use or
loss of integrity, etc.
The organization distributes, accesses, and
searches the data that have been previously
recorded while maintaining the documentation
and monitors for changes as required by the
standard to ensure proper data control. In
addition, the recorded data of external origin is
thoroughly checked and identified in a correct
way.
Implementation and monitoring
Surveillance and monitoring management
systems are essential components of any
healthcare organization to ensure patient safety.
These systems should include measuring
instruments and equipment that assist in analysis
and assessment during service provision. The
organization employs various monitoring
methods, including remote monitoring, when
patients are outside the service-providing
organization's premises. Conducting monitoring
ensures the evaluation of the effectiveness and
performance of the quality management system
while preserving relevant information in the
documented form with confirmation of the
provided results.
In a healthcare organization, monitoring is
carried out to reflect the patient's clinical
condition and gauge patient satisfaction with
their own needs. The organization's task in
implementing a monitoring system is to
determine methods for obtaining and observing
data by providing key features and data analysis
during service delivery. Analyzing and
evaluating data during monitoring and
measurement allows the establishment of:
− adherence to the execution and quality
provision of services by staff.
− the level of patient satisfaction.
− expected planning effectiveness.
− the need for corrective actions to enhance
the Quality Management System (QMS), as
well as the effectiveness of measures to
prevent and mitigate risks and opportunities.
Audit and certification
The organization carries out internal audits as per
planned schedules to gather information on how
well the Quality Management System (QMS)
satisfies the needs and demands of the company
according to ISO 9001:2015 Standards. To
achieve this, the organization plans, executes,
and develops audit programs that cover and
comprise the audit frequency, methods, planning
needs, and duties. The audit program evaluates
potential effects on processes that impact the
organization and defines each audit's criteria and
scope while reporting the results to the
management.
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The main stages of an internal QMS audit in a
healthcare organization include:
1. Audit Planning. This stage involves
identifying areas subject to audit, creating an
audit plan, and selecting the audit team.
2. Audit Execution. Auditors assess QMS
compliance with defined requirements and
procedures. They include reviewing
documentation, observing processes, and
conducting interviews with staff.
3. Results Analysis. After the audit, auditors
analyze collected data to determine QMS
compliance. They identify discrepancies and
provide recommendations for addressing
them.
4. Implementation of Changes. Based on audit
results, the organization develops and
implements a plan to make necessary
changes to the QMS. These changes might
involve updating procedures, enhancing
staff qualifications, or adopting new
technologies.
5. Effectiveness Review. After implementing
changes, the organization verifies its
effectiveness by conducting subsequent
audits. This evaluation assesses the results of
changes and identifies any new
discrepancies or non-conformities.
Internal QMS audits in a healthcare organization
are conducted to identify potential issues,
pinpoint areas for improvement, and enhance the
quality of medical services provided. Conducting
these audits regularly and systematically ensures
continuous improvement of quality management.
Continuous improvement
The healthcare organization should consider
searching for and addressing opportunities that
can improve and perform various actions as
necessary to meet the needs of patients and
gradually increase the level of satisfaction during
the service. The following measures are taken
into account:
− improving the types of services aimed at
meeting the requirements and needs of
patients both in real-time and in the future.
− making amendments (adjustments) to avoid
and reduce the impact of negative factors
and factors.
− corrective actions, innovations, and
reorganization that affect the effectiveness
of the quality management system.
In some cases, corrective actions are considered
if there is a discrepancy in the quality
management system. It is accompanied by
complaints from patients and their level of
dissatisfaction. In order to resolve the non-
conformity, it is necessary to respond and take
preventive actions aimed at identifying the
causes of the non-conformity and analyzing them
to make adjustments and make decisions in
advance about the consequences of individual
incidents with ongoing monitoring. Based on the
identification and analysis of non-compliance, it
is possible to conduct a needs assessment to
avoid repeated occurrences of undesirable
incidents, as well as to anticipate the potential for
their occurrence in advance. In some cases, if
necessary, risks and opportunities are updated
during planning and implementation with
changes to the quality management system. It
allows for minimizing non-compliance on the
part of the healthcare organization during the
provision of services and maintenance.
An institution must continuously work to
improve its quality management system's
suitability, adequacy, and effective performance
to improve clinical practices and outcomes. The
improvement involves the use of available
analysis and evaluation results from baseline data
to identify the need for improvement of the
quality management system.
Development of an effective quality
management strategy
The quality management strategy contains a list
of requirements of the 9001:2015 Standard that
have been reviewed and used to build the quality
management scheme shown in Figure 2.
As can be seen from Figure 2, the effectiveness
of solutions requires creating conditions
(obligations and responsibilities) where
leadership includes teamwork with a competent
team (staff). After that, it is necessary to adapt
quality improvement initiatives and bring them
to the organizational context. For strategy
development, it is required to create and
implement quality management improvement
initiatives that are in the organization's interest
with practical value and impact on the main
helpful contributions to clinical performance.
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Figure 2. Flowchart of sequential operations for implementing a QMS strategy.
Source: El-Zein, G. Impacts of Quality Improvement Strategies on the Performance of Primary Healthcare
Organisations (El-Zein, 2021).
Once sustainability initiatives are established and
implemented, it is necessary to define
management and clinical policy boundaries with
procedures that focus on patient care and service
delivery. When defining the boundaries of
management and clinical policy, monitoring
should be involved to determine the assessment
of operational processes that focus on patient
safety. Also, it should include available tools that
improve the health information system for better
decision-making. Based on the developed
strategy, the quality improvement initiative is
integrated. It creates a sustainable organizational
system with a dynamic of continuous
improvement.
Continuous improvement of quality in the
healthcare system is a challenge for many
countries worldwide. It is incredibly challenging
for those in complex stages of transitioning from
outdated and inefficient quality systems, where
medical approaches and services vary
significantly due to the lack of consideration and
implementation of more modern Quality
Management Systems (QMS). For instance, in
recent years, Kosovo, on the path to European
integration, has started implementing new
quality management systems per EN ISO 9001
requirements, incorporating continuous
monitoring systems in healthcare, and
establishing benchmarks for best practices
(Lleshi, 2020).
The assessment of medical service quality should
be based on quality indicators and criteria, with
continuous monitoring and evaluation at all
stages of healthcare provision being the most
crucial. Achieving high-quality medical services
requires constant refinement and adaptation to
patient needs, involving measures to satisfy
patient needs and enhance their experience
(Nothacker et al., 2021). Nadziakiewicz &
Mikolajczyk (2019) suggested that organizations
should shift from numerous disconnected
initiatives to integrated strategies capable of
improving outcomes and delivering value for
money spent. Studying new quality tools and
assessment methods can provide healthcare
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organizations and patients with fair and
sustainable solutions.
Lately, new and innovative sustainable
development systems are being introduced and
proposed in healthcare organizations. These
systems are compatible with hospital
accreditation standards and differ from others by
focusing on medical institutions with continuous
improvement of management systems by
establishing performance indicators to achieve
sustainability (Burgers, van der Weijden & Grol,
2020). Moldovan & Bataga (2022) proposed a
self-assessment based on a framework system
that supports medical institutions in determining
performance levels in all defined areas. It aids in
identifying improvement opportunities and
making decisions regarding priority actions.
The implementation of an ISO 15189-based
QMS in laboratory work provides a strong
foundation for laboratory quality to ensure
patient safety and prevent patient safety issues
(Allen, 2013). In the case of such issues, effective
processes exist for investigation and preventive
measures. However, addressing patient safety
issues in laboratories largely depends on the
presence of an effective quality management
system.
Conclusions
In this study, the authors have analyzed the
quality management strategy in the healthcare
sector. The research examined key factors in the
development and implementation of a quality
management system standard. These factors
include: analysis of organizational needs;
adaptation of standards to administrative
requirements; planning and implementation;
staff involvement; data collection and analysis;
monitoring; conducting internal audits to achieve
continuous improvement.
Based on the ISO 9001:2015 Standard "Quality
Management Systems – Requirements", the
authors analyzed each factor's impact on
enhancing or compromising the quality
management system at each implementation
stage. Special attention is given to planning, staff
involvement, and conducting internal audits, as
these can lead to adjustments during the initial
planning stages if expected results are not
achieved or if discrepancies arise according to
standard requirements.
The primary goal of healthcare organizations
during planning is to define quality objectives
and plan actions for effective achievement. It
involves setting quality objectives that involve
relevant departments in executing medical
operations and processes directly linked to the
Quality Management System (QMS).
The healthcare institution's medical personnel
must be competent and knowledgeable, capable
of applying their expertise for proficient service
delivery. The competence depends on
knowledge, skills, and communication. All these
can impact both improvements and deteriorations
in patient service quality. Thus, planning may
need adjustments based on this personnel
competence.
To adequately control documented information,
the organization must manage the distribution,
access, search, and preservation of
documentation, as well as monitor changes as
required by the standard. Additionally, recorded
external data used for QMS planning should be
thoroughly reviewed and properly identified.
Internal auditing of the QMS in healthcare
organizations helps identify potential problems,
pinpoint areas for improvement, and enhance the
quality of medical services. This process should
be conducted regularly and systematically to
improve ongoing quality management.
Healthcare organizations should actively seek
and address opportunities for improvement to
meet patient needs and progressively enhance
satisfaction levels during service. The
organization must consistently improve its
quality management system's suitability,
adequacy, and effectiveness to enhance clinical
practices and indicators. Improvement considers
the results of analysis and assessment based on
initial data. It aims to identify the needs for
improving the quality management system.
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