Evaluating the Effects of Quality Assurance: A Comparative Analysis between ISO 9001
Certified and Non-certified Hospitals in Turkey
Ozkan Tutuncu, Assoc. Prof. Dr., Dokuz Eylul University, Quality Improvement and
Accreditation in Healthcare Department, Turkey.
Deniz Kucukusta, Ph D., Dokuz Eylul University, Quality Improvement and Accreditation in
Healthcare Department, Turkey
Abstract
The main purpose of this study is to determine which dimensions of quality management
system differs significantly in ISO certified and non-certified hospitals within the perceptions
of healthcare employees in Turkey. A structured questionnaire was used to assess the
perceptions of health care employees. A stratified random sampling method was used in 3
ISO certified and 3 non-certified medium scale hospitals in Izmir, Turkey. 1000
questionnaires were distributed and approximately 80% returned. Results show that the most
important factor was continuous improvement in both service quality and quality management
sytem. The differences of the perceptions of the respondents towards quality management
dimensions were significant.
Introduction
Quality assurance aims to ensure that the product or service an organization provides is fit for
its purpose and meets customer expectations. It is about managing business process so that
both the supplier and the customer are satisfied with the quality and the consistency of the
goods and services provided. In health care, Quality assurance (QA) can be defined as all
activities that contribute to defining, designing, assessing, monitoring, and improving the
quality of healthcare. These activities can be performed as part of the accreditation of
facilities, supervision of health workers, or other efforts to improve the performance of health
workers and the quality of health services.
Quality Assurance and ISO Certification
ISO 9000 has been the most commonly implemented quality innovation by US and European
organizations in the last decade (The International Standards Organization survey of ISO
9000, 2000). It requires that organizations have verifiable routines and procedures in place for
product design, manufacture, delivery, service and support. Vloeberghs & Bellens (1996) also
argued that strong senior management commitment had a positive effect on ISO 9000
implementation. Additionally, the cross-functional management team is also an important
factor for successful ISO 9000 implementation. One of the reasons why a team is important is
that quality management is a collective activity which transcends both individuals and
departments (Stamatis, 1995).
Under the ISO 9000 standard, an organization must monitor strictly the sequence of steps it
takes for the completion of a job (Cole 1999, Brunsson et al. 2000). For this purpose, it must
follow process documentation; no shortcuts are supposed to take place. To guarantee
compliance with the standard’s requirements, third-party auditors evaluate a supplier’s
procedures and carry out site visits twice a year to verify compliance. The end-result is
supposed to be an improvement in the organization’s performance.
It is also important to empower employees, giving them the power to make decisions and take
corrective actions where necessary to get the job done. Managements need to look at the
firm’s benchmark partners to recognize its own weaknesses and take appropriate actions to
improve efficiency.The ISO 9001: 2000 certification has its own chapter due its strong
emphasis in customer satisfaction and the importance of quality management systems to
improve organizational performance in all aspects (Chan, 2000). The ISO can be “a safe way”
to get and offer quality. The quality offered by the establishment can meet or not the
customer’s expectation but one important advantage for the establishment is having the
certification of the establishment as a whole, from top to bottom after the firm has been
submitted to hard quality procedures. ISO certification is identified as an important factor in
implementing continuous quality improvement and total quality management and in
promoting integration in health care systems. Certification and accreditation has also been
identified as an important factor in promoting patient safety and error reduction in health care
organizations (Tutuncu et al.,2007).
Each management practice, especially ISO 9000, may have special characteristics, which
make it different from other organizational practices (Naveh et al. 2004). This study aims to
make a comparison between ISO certified and non-certified hospitals in order to evaluate the
differences and effects of quality systems. Results may be beneficial for the hospitals or other
health care organizations in the quality assurance process. Also this study may be
enlightening for the healthcare organizations which parts of the quality system are perceived
more important by the healthcare employees in the aspects of service quality and total quality
management system and patient safety.
Methodology
Data was obtained by administrating a structured-questionnaire survey consisting two parts.
The main part of the survey was made up of quality management system which inquires 39
questions. There were three overall statements in the second part, regarding dependent
variables, which were representing general perceptions about the quality management system,
service quality and patient safety. The last part inquired demographic and nominal questions
about the nurses. The items were rated on a five-point scale (1= strongly agree; 2=agree;
3=neither agree nor disagree; 4=disagree; 5=strongly disagree). The employees were asked to
rate these statements. The survey was conducted in 3 certified and 3 non-certified, middle
scale hospitals in Izmir, Turkey. To make the comparison possible, the hospitals were chosen
with similar characteristics in terms of scale and number. In total, 1000 questionnaires
distributed by the researchers and usable 803 questionnaires were returned, with a usable
response rate of 80,3%, which is statistically acceptable for data analysis. Data obtained was
analyzed by using a SPSS program. Data analysis consisted of frequency distribution,
correlation analysis, factor analysis, and regression analysis at the base of derivative and
inferential statistics.
Findings
803 respondents have gone under the research. According to the frequency distribution 82 %
of them were women and 18% were men. 75% of the respondents have minimum university
degree. Of the respondents, 47% have ISO certification where the others have none. 60 %
were nurses and 15 % were medical doctors where the rest of them were other medical staff.
The reliability tests have been implemented on data at the base of derivative statistics. The
general Cronbach’s alpha of data is found to be as 0,98. In accordance with Cronbach’s alpha
result obtained, the factor analysis has been implemented on data.Table 1 shows the factor analysis,
mean values and correlation analysis results.
Table 1. Factor Analysis and Correlation Results
FACTOR 1 –
KAIZEN
FACTOR 2 –
Management
Responsibility (MR)
FACTOR 3 –
Quality System
Requirements (QSR)
Eigenvalue
Variance
Explained
Mean
KAIZEN
MGT
RES
22,318
58,730
3,20
1
1,597
4,203
3,19
,905
1
1,163
3,060
3,35
,877
,867
QSR
1
RM
FACTOR 4–
Resource
1,003
2,640
2,70
,806
,794
Management (RM)
KMO= ,974 Total Variance Expl= 68,633 Barlett Test= 14238,865 Sig.=0,000
,694
1
Regression analysis is made to determine the importance of independent variables
(dimensions in Table 1) on dependent variables (take in Table 2,3 and 4). There were three
dependent variables.
Table 2. Regression Analysis of the Factors Affecting the Overall Quality Management
System

T
Sig T
KAIZEN
,344
5,310
,000
Management Resp
,318
5,209
,000
Quality Mgt System
,186
4,271
,000
Resource Management
,124
3,183
,002
Constant
,216
2,536
,000
VARIABLES
Multiple R=,845; R square =,714; Adjusted R Square =,712 F=421,400; Signif F=,001
Table 3. Regression Analysis of the Factors Affecting the Overall Service Quality

T
Sig T
KAIZEN
,389
5,933
,000
Resource Management
,174
3,921
,000
Management Resp
,234
3,579
,000
Constant
,544
10,647
,000
VARIABLES
Multiple R=,737; R square =,544; Adjusted R Square =,542 F=268,603; Signif F=,000
In order to compare the difference between ISO certified and non-certified hospitals, T-test
was used. According to the T-test, the mean values of all the dimensions in both hospital
types differ significantly (p=0,000). Table 4 shows the descriptive statistics of the T-test.
Table 4. Descriptive statistics of T-test
KAIZEN
Mgt Resp
Quality Mgt Sys
Resource Mgt
ISO
Certified
Non-certified
Certified
Non-certified
Certified
Non-certified
Certified
Non-certified
N
380
422
380
420
380
319
380
416
Mean
3,9413
2,5438
3,8571
2,5978
4,0782
2,4915
3,3020
2,1583
Std. Deviation
,68066
,69263
,68677
,65389
,67747
,93101
,89392
,59638
Std. Error Mean
,03492
,03372
,03523
,03191
,03475
,05213
,04586
,02924
Conclusion
In health care, Quality Management System (QMS) is identified as an important factor in
implementing continuous quality improvement and total quality management and in
promoting integration in health care systems. The quality management system was analyzd
under 4 dimensions These dimensions were determined after the exploratory factor analysis.
The main purpose of this study was to determine which dimensions of quality management
system differs significantly in ISO certified and non-certified hospitals within the perceptions
of healthcare employees in Turkey. The results of this study supports that the main and the
most important factor of the quality system was named as KAIZEN, which represents
measurement, analysis continuous improvement and service actualization. This core
dimension has a very strong effect in both overall quality management system and service
quality. Resource management and management responsibility also strongly affect quality
system. All the dimensions are strongly and positively correlated with each other, meaning
that the quality system and its parts are perceived almost unique. All the dimensions of the
management system differ significantly between certified and non certified hospitals. In ISO
certified hospitals, continuous improvement, management responsibility and resource
management dimensions are perceived positively and more important. This result also shows
how the quality management system leads to positive approach in healthcare staff towards
management
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