Ozkan Tutuncu, Ph.D.
Dokuz Eylul University, Department of Quality Improvement and Accreditation in Healthcare, Turkey, ozkan.tutuncu@deu.edu.tr
Patient safety aims to prevent harm and negative outcomes of care. Quality management systems are an important factor in promoting patient safety and reducing the risk of adverse events and medical errors in health care organizations. The main aim of this study is to evaluate the relationship among the dimensions of patient safety culture and quality management systems. A structured-questionnaire survey was conducted in 3 certified and 3 non-certified hospitals in Turkey. 803 questionnaires were collected. Results show that the scales are both valid and reliable. All dimensions of the quality management system and patient safety differ significantly among certified and non certified hospitals. Kaizen, management responsibility, resource management, reporting, communication, organizational learning, team work, evaluation and processes are perceived positively and more important in ISO certified hospitals rather than non-certified hospitals. These results show how the quality management system leads to positive approach in healthcare staff towards patient safety.
Keywords : Patient Safety, Quality Management System, ISO 9000
INTRODUCTION
Accidents and complications are common in health care and can be deadly. Only in the 1990s did errors in health-care settings begin to draw public attention. Adverse medical events, as injuries to patients that arise from mistakes and accidents during medical treatment are called, can be result of human errors, technological errors, or a system that failed to detect these mishaps and prevent them (Bernstein, et al ., 2003). Patient safety incidents have been shown to cause harm in between 3% and 17% of hospital inpatients (Vincent &
Woloshynowych, 2001; Brennan et al.
, 1991; Wilson et al.
, 1995; Davis et al.
, 2002; Baker et al.
, 2004; Ali et al.
, 2007). Institute of
Medicine estimates that (IOM) 44,000 to 98,000 Americans die every year as a result of adverse medical events or of medical mistakes
(Kohn & Donaldson, 2000). IOM further estimates the national cost of preventable medical errors in hospitals at $17 to $29 billion a year, of which the cost of medication errors alone is at least $3.5 billion (Kohn & Donaldson, 2000; Aspden et al.
, 2007).
Potentially preventable medical errors that occur after or during surgery may cost employers nearly $1.47 billion a year for USA
(Encinosa & Hellinger, 2008). The IOM report ‘To Err is Human’ (Kohn & Donaldson, 2000) impacted all health care systems, and in response an atmosphere of lesson learning from accidents and near accidents began (Stern, 2008).
It has been well recognized widely and internationally that hospitals are not as safe as they should be (Johnstone & Kanitsaki, 2006).
Having a culture that promotes safety within the organization is an important and necessary precursor to improving the insufficiencies in patient safety (Pronovost & Sexton, 2005).
Total Quality Management (TQM) is based on the premise that customers should be the focus of the organization. All the studies and improvements should aim the customer satisfaction in TQM and quality management system
(QMS). The term customer reflects both internal and external customers. Customers can be patients (Tutuncu, et al ., 2005).
The ISO 9000 certification or quality management system has its own chapter due its strong emphasis in customer satisfaction and the importance of QMSs to improve organizational performance in all aspects (Chan, 1998). The ISO 9000 series of standards is a nongovernmental organization established to promote the development of standardization and related activities. The goal is to facilitate the international exchange of goods and services, and to develop cooperation in the spheres of intellectual, scientific, technological and economic activity (Bhuiyan & Alam, 2005). It establishes a clear document system throughout the organization, a common language across the organization and common identifiers for customers or patients (Cochran, 2002).
Both quality and safety are fundamental to health care delivery. Strong institutional capabilities and political commitment have been important factors for making the transition and change (Lim, 2004).
Improving safety requires respecting human abilities by designing processes that recognize human weaknesses and strengths (Donaldson, 2008). In recent decades, organizational factors have been recognized to be of great importance for safe processes and quality operations (Reason, 1993). In order to redress this situation, health care organizations around the world have turned their attention to strategically implementing robust patient safety and quality care programs to identify circumstances that put patients at risk of harm and then acting to control or prevent those risks (Johnstone &
Kanitsaki, 2006).
LITERATURE REVIEW
The literature is reviewed in order to ascertain the relevant research on patient safety, ISO 9000 certification and quality management system, and patient safety and quality management system.
Health care organizations are becoming aware of the importance of transforming organizational culture in order to promote patient safety
(Nieva & Sorra, 2003). The safety culture of an organization is the product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine the commitment to, and the style and proficiency of, an organization’s health and safety management (Cox & Cox, 1991). It is a snapshot of the state of safety providing an indicator of the underlying safety culture of the

work group, plan or organization” (Flin et al., 2000). Health care is often delivered in a dynamic environment with complex interactions among patients, medical staff, infrastructure, equipment, and policies and procedures (Institute of Medicine, 1999; Nolan, 2000). Patient safety efforts have as their primary goal the prevention, avoidance, and mitigation of patient harm caused by deficiencies in the processes of patient care delivery (Kohn & Donaldson, 2000; Cook et al., 2000; Rangaraj Cook et al., 2005).
The issue of human errors in complex systems has been a topic of debate for decades. It is widely recognized that human factor and error is the main cause of accidents not only in human and machine system operations but also in health care (Bogner, 1994; Cook et al ., 1998;
Leape, 1994; Wears & Perry, 2002; Kohn et al ., 2000; Carayon et al ., 2003). A strong safety culture can help minimizing medical errors.
In order to assure patient safety, healthcare leaders have been encouraged to take responsibility for reducing medical errors and adverse events in a strong safety culture (Institute of Medicine, 2001; Joint Commission on Accreditation of Healthcare Organizations, 2003;
National Quality Forum, 2002, 2003).
Patient safety encompasses the processes and systems that protect patients from injury caused by medical mismanagement. Patient safety aims to prevent harm and negative outcomes of care. Ensuring patient safety requires operational processes and systems that will maximize the likelihood of preventing adverse medical events (Institute of Medicine, 1999). The health care arena has embraced the various models and approaches to human error in order to analyze and evaluate risk and safety (Reason, 2000; Vincent et al ., 1998).
Increasing emphasis on objective measures of organizational and personal results can promote the use of comparative data and clinical benchmarking (Shaw, 2000). Leaders can use to instill a strong safety culture in their healthcare organizations, and they have few metrics to evaluate their own efforts to achieve this goal (Flin et al ., 2004). Few hospital leaders devote sufficient resources or time to patient safety (Leape & Berwick, 2005). In addition, some leaders do a better job than others in their effort to communicate their commitment to patient safety (Singer & Tucker, 2005). Safety culture is affected by organizational changes, such as a change in leadership or the introduction of new systems and processes, and practices of the organization (Parker et al.
, 2006; Fleming & Wentzell, 2008).
ISO 9000, the most prominent example of a certified management standard was created by ISO. It is a family of standards developed to assist organizations implement and operate effective quality management systems (Russel, 2000). It specifies requirements for a quality
ISO 9000 has been the most commonly implemented quality management system. According to the literature, pursuit of ISO 9000 series certification is primarily motivated by the need to enter the competitive pressures, global marketplace, or customer requirements (Rayner
& Porter, 1991; Terziovski et al ., 1997; Anderson et al., 1999; Beattie & Sohal, 1999; Chang & Lo, 2005). It is a set of activities intended to establish confidence that quality requirements will be met (ISO, 2005). ISO further defines the quality management system as
"a set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and quality objectives are achieved” (ISO, 2005). Therefore, ISO 9000 provides a methodology and framework to evaluate whether an organization has effectively and efficiently defined, integrated, organized, and synchronized its operational resources to optimize performance and ensure customer satisfaction. It is a management practice that aims to get organizations to satisfy customer needs at each stage in the value chain (Stephens, 1994; Uzumeri, 1997; Naveh et al ., 1999; Anderson et al .,1999; Cole, 1999; March et al ., 2000). 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).
QMS is identified as an important factor in implementing continuous quality improvement and total quality management and in promoting patient safety culture and climate for error reduction in health care organizations (Tutuncu et al ., 2007b). ISO 9000 QMS requires that organizations have verifiable routines and procedures in place for product design, manufacture, delivery, service and support. There is already significant and increasing use of ISO certification in health care organizations (Sweeney & Heaton, 2000).
Yet, uncertainty still exists about the role and function of ISO 9000 QMS in health care organizations.
The pressing need to increase the reliability of health care systems to reduce frequency of adverse events has placed a renewed focus on the role of QMS in promoting patient safety. Moreover, ISO 9000 synergistically augments and enhances the long-standing benefits of health care accreditation and produces continuous quality improvement for reducing adverse events to effectively respond to technology's fast-moving continuum of change (Crago, 2000). Each management practice, especially ISO 9000, may have special characteristics, which make it different from other organizational practices (Naveh et al.
, 2004).
The new paradigm focuses on the systems rather than centering on individual errors, necessary to facilitate and enhance quality and protect patients. QMSs and excellence models affect performance and help organizations achieve organizational excellence (Tutuncu &
Kucukusta, 2007). Quality management systems are an important factor in promoting patient safety and reducing the risk of adverse events and medical errors in health care organizations. The healthcare industry settled on a quality issue. Patient safety has proven to have more staying power than previous quality initiatives, such as quality management systems and total quality management (Tutuncu
& Erbil, 2006). Patient safety provides a continual flow of opportunities to improve that may require the use of TQM concepts and QMS.
A positive safety climate includes the active involvement of the organizational leadership in safety programs, high rank and status for safety professionals, strong safety training programs and communication processes, and a clear emphasis on recognition for safe performance, rather than a reliance on punishment and enforcement (Sexton et al.
, 2000; Gaba et al ., 2003; Beyea, 2004; Singer et al .,2003; Geller, 2000). Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures (ACSNI, 1993). As a result, researchers, policymakers, and health care providers have intensified their efforts to understand and change organizational conditions and processes of health care systems as they relate to safety and quality.
Despite the importance of management standards such as ISO 9000, they remain relatively understudied (Terlaak &King, 2006). A few studies have proposed that management standards entail a recipe of beneficial practices and thereby improve the operational performance of certified organizations (Rao et al.
, 1997; Litsikas, 1997). 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). Healthcare organizations can focus on teams and team leaders as potentially powerful forces for bringing about the management of patient safety and better quality of care (Cozenz, 2001).
Of particular interest are studies that assess and focus on the effectiveness of educational interventions to increase the awareness of health care staff about patient safety and managerial interventions to heighten the culture of safety in hospitals (Perneger, 2006).
A smaller group of studies focuses on direct links between culture or climate and behaviors or outcomes that are related to quality (Stone, et al.,
2007). The dependent variables in these researches include employee absenteeism, patient satisfaction, implementation of evidencebased care management practices, and performance (Eriksen et al., 2003). However, solid evidence showing impacts and relations between patient safety culture or climate and quality management system is sparse. Although the patient safety concept has been recently gaining attention in healthcare system in Turkey, several studies emphasizing the importance of the issue has been made (Tutuncu et al .,
2007a; Tutuncu et al ., 2007b)
The main aim of this study is not only to reemphasize the necessity of the safety studies in the hospitals, but also to stress the impact of patient safety climate and quality management. The study focuses on relationship among the dimensions of patient safety culture and quality management systems in ISO certified and non-certified hospitals. Also this study may be enlightening for the healthcare organizations which parts of the quality management systems and patient safety are perceived more important by the healthcare employees. Research makes a comparison between ISO certified and non-certified hospitals in order to evaluate the differences and effects of patient safety and quality management systems. Results may be beneficial for the hospitals or other health care organizations in the quality assurance process. Therefore, hypothesizes of this study can be stated as follows:
H1: There is a correlation between patient safety and quality management system.
H2: Dimensions of quality management system perceived positively and more important in ISO certified hospitals.
H3: Dimensions of patient safety culture perceived positively and more important in ISO certified hospitals.
RESEARCH METHODOLOGY
Data was obtained by administrating a structured-questionnaire survey consisting four parts. The first part of survey was adapted from patient safety culture survey of the Agency for Healthcare Research and Quality (AHRQ) which inquires six dimensions and 29 items.
Reliability and validity of this scale has been proved by AHRQ researchers. Quality management system survey is developed in the second part of survey which inquires 4 dimensions and 38 items. Since the scales were to be used in Turkey, it has to be retested against validity and reliability. The reliability and validity have been proved in recent studies (Tutuncu & et al ., 2007a; Tutuncu & et al ., 2007b;
Tutuncu & Erbil, 2006). Their reliabilities and construct validities have been confirmed. There were three overall statements in the third 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 participants. 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.
A stratified random sampling method is applied in research. 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 percentage, which is statistically acceptable for data analysis. Data obtained was analyzed by using a SPSS 13.00 program.
Data analysis consisted of frequency distribution, factor analysis, reliability test, T-test and correlation analysis.
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. Cronbach’s alpha of quality management system is 0,98 and alpha of patient safety is 0,94 (p<0.001).
In order to get construct validity, exploratory factor analysis has applied to quality management system set. 69 percantage of total variance is explained by factors of quality management system. Table 1 shows the factor analysis of quality management system. It shows that the quality management system has four dimensions; kaizen, management responsibility, quality requirements and resource management.
Table 1Factor Analysis of Quality Management System
Eigenvalue
Variance
Explained
Mean F
α p
FACTOR 1 – Kaizen
(15 Items)
FACTOR 2 – Management Responsibility
(12 Items)
22,318
1,597
58,730
4,203
3,69
3,47
11,183
12,906
0,97
0,95
0,001
0,001
FACTOR 3 – Quality System Requirements
(6 Items)
FACTOR 4
– Resource Management
1,163 3,060
1,003 2,640
(5 Items)
KMO=0,974 Total Variance Explained= 68,633 Barlett Test= 14238,865 Sig.=0,001
3,35
2,70
18,783
284,865
0,94
0,88
0,001
0,001
In order to get construct validity, exploratory factor analysis has applied to patient safety set. According to the factor analysis, 66 percantage of total variance is explained by the dimensions of patient safety. Items which form the patient safety culture are grouped in six dimensions; reporting, communication, organizational learning, team work, evaluation and processes, those of which were labeled according to their common contents. Table 2 shows the factor analysis of patient safety culture. Results show that the scales are both valid and reliable for hypotheses tests and multivariate data analysis.

Table 2Factor Analysis of Patient Safety Culture
FACTOR 1
FACTOR 2
FACTOR 3
FACTOR 4
FACTOR 5
FACTOR 6
– Reporting (3 Items)
– Communication (6 Items)
– Org. Learning (7 Items)
– Team work (6 Items)
– Evaluation (3 Items)
– Processes (4 Items)
Eigenvalue
10,699
2,235
1,857
1,783
1,427
1,203
Variance
Explained
36,894
7,708
6,403
6,147
4,919
4,147
Mean
2,61
2,70
3,33
3,09
2,34
3,54
F
44,795
80,613
209,135
34,921
56,360
82,838
α
0,91
0,89
0,87
0,87
0,83
0,70 p
0,001
0,001
0,001
0,001
0,001
0,001
KMO=0,923 Total Variance Explained= 66,218 Barlett Test= 13524,661 Sig.=0,001
In order to analyze the relationship between QMS and patient safety culture, correlation coefficient values were calculated. Table 3 shows the correlation analysis between QMS and patient safety culture. As Table 3 shows, there is a positive relationship (r = ,80 and p<0.001) between two factor attributes. First hypothesis is “There is a correlation between patient safety and quality management system”. H1 is supported here.
Table 3Correlation Matrix between QMS and Patient Safety Culture
Patient Safety Culture
Quality Management System
Pearson Correlation
Sig. (2-tailed)
N
Pearson Correlation
Sig. (2-tailed)
N
Patient Safety Culture
1
803
,723
,001
803
Quality Management System
1
803
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. For comparing the differences of quality management system between ISO certified and non-certified hospitals, T-test was used. According to the T-test, all the dimensions of the quality management system differ significantly between certified and non certified hospitals
(p<0.001). Table 4 shows the descriptive statistics of the T-test.
Table 4- Descriptive Statistics of QMS according to ISO Certified and Non-certified Hospitals
ISO N Mean Std. Deviation Std. Error Mean
Kaizen Certified 380 3,9413 ,68066 ,03492
Non-certified 422 2,5438 ,69263 ,03372
Mgt Resp
Quality Sys Req
Resource Mgt
Certified
Non-certified
Certified
Non-certified
Certified
380
420
380
319
380
3,8571
2,5978
4,0782
2,4915
3,3020
,68677
,65389
,67747
,93101
,89392
,03523
,03191
,03475
,05213
,04586
Non-certified 416 2,1583 ,59638 ,02924
Kaizen, management responsibility, resource management dimensions are perceived positively and more important in ISO certified hospitals. Second hypothesis is “Dimensions of quality management system perceived positively and more important in ISO certified hospitals”. H2 is supported here. In order to compare the differences of patient safety culture between ISO certified and non-certified hospitals, T-test was used. Table 5 shows the descriptive statistics of the T-test.
Table 5- Descriptive Statistics of Patient Safety Culture according to ISO Certified and Non-certified Hospitals
Reporting
Communication
Org. learning
Team work
Evaluation
ISO
Certified
Non-certified
Certified
Non-certified
Certified
Non-certified
Certified
Non-certified
Certified
N
379
420
380
423
380
423
380
423
380
Mean
3,0321
2,2310
3,0662
2,3814
3,8183
2,9006
3,4084
2,8013
2,6781
Std. Deviation
1,09253
1,01610
1,00428
,84060
,64272
,75877
,82229
,82501
,89701
Std. Error Mean
,05612
,04958
,05152
,04087
,03297
,03689
,04218
,04011
,04602

Non-certified 423 2,0307 ,81090 ,03943
Processes Certified 380 3,7373 ,69597 ,03570
Non-certified 423 3,3694 ,69490 ,03379
According to the T-test, all the dimensions of patient safety culture differ significantly between certified and non certified hospitals
(p<0.001). Reporting, communication, organizational learning, team work, evaluation and processes are perceived positively and more important in ISO certified hospitals rather than non-certified hospitals. The study indicates that dimensions of patient safety and quality management systems are correlated with each others (p<0.001). Third hypothesis is “Dimensions of patient safety culture perceived positively and more important in ISO certified hospitals”. H3 is supported here.
CONCLUSION
The report of Institute of Medicine triggered wide-spread discussion of adverse events by the public and caregivers. Improving patient safety must continue to be a priority for health care organizations. In order to prevent or reduce the impact of latent adverse events, a system approach and better change management capabilities are required. System failures and errors emphasize over direct human error, and accentuate the crucial role that organizational culture plays in ensuring safety. Because of the fact that patient safety being the fundamental issue for the hospitals, organizational quality approach towards patient safety actions in hospitals makes up the dimensions of patient safety culture for health care employees.
Research results shows that there is a link between patient safety culture and quality management system. Both quality system and patient safety are positively correlated with each other. All the dimensions of the quality management system and patient safety culture 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. In addition, reporting communication, evaluation, organizational learning, team work, and processes are perceived positively and more important within the context of patient safety for ISO certified hospitals. These results show how the quality management system leads to positive approach in healthcare staff towards patient safety. Reducing the risk of error for promoting patient safety culture will require a substantial and sustained quality effort at all levels of the health care system. QMS can be identified as an important factor for creating safety environment in healthcare organizations. In order to be successful, patient safety processes should be designed and executed using quality management principles.
ISO 9000 can effectively help healthcare organizations to better manage continuous quality improvement for reducing adverse events while facilitating synergy with regulatory processes.
If health care organizations are to transform their processes for promoting patient safety, the logic of organizational change should start to drive patient safety efforts. Establishing a logical ISO 9000 quality management system in a health organization can be evaluated in a system approach. Universities may educate healthcare professionals and managers about the scope of the patient safety problem and potential strategies such as ISO 9000 series “quality management systems” or other accreditations in order to reduce adverse events. ISO
9000 series QMSs have some really valuable standards such as ISO 9001 QMS for all health care organizations, ISO 13485 for medical devices, ISO 15189 for medical labs, IS0 14001 for medical wastes, ISO 22001 for foods and packaging, ISO 27001 for information security and OHSAS for occupational health and safety. They can be integrated to the organization and system for improving patient safety in health care industry.
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