Risk Assessment and Implementation of ISO 90012015 in Relation To Institutional Performance

Volume 8, Issue 3, March – 2023 International Journal of Innovative Science and Research Technology
ISSN No:-2456-2165
Risk Assessment and Implementation of ISO

9001:2015 in Relation to Institutional Performance
Imelda O. Reyes Efren A. Barillo
Office of the VPAA College of Business and Mangement
Misamis University Misamis University
Ozamiz City, Philippines Ozamiz City, Philippines
Abstract:- Quality has become an increasingly crucial and I. INTRODUCTION

critical success component in higher education institutions,
particularly universities. The performance of an The International Organization for Standardization (ISO)
institution strongly depends on the overall quality of the has promoted and advocated for the standardization of quality
management system which operates in schools. This study management systems and their standards in nearly all
looked into the risk assessment and the level of technological and economic domains. ISO has recently
implementation of ISO:9001: 2015 in relation to expanded its operations into additional areas of social and
institutional performance of Misamis University, Ozamiz environmental policy. ISO 9001 is one of the most well-known
City. The study utilized a descriptive-correlational design. and commonly used international quality standards (Hussein,
A total of 120 faculty and staff served as respondents and Abou-Nassif, Aridi, M., Chamas, & Khachfe, 2017).
were chosen through purposive and random sampling.
Implementation of ISO 9001:2015 Questionnaire, At higher education institutions, particularly universities,
Institutional Risk Assessment Questionnaire, and quality has become an increasingly important and key success
Institutional Performance Questionnaire were used to factor (Vykydal, Folta, &Nenadál, 2020). As a result, quality
gather data. Mean, Standard Deviation, Pearson Product Management System (QMS) implementation has expanded
Moment Correlation Coefficient, and Regression Analysis dramatically in recent years across a wide range of institutions
were the statistical tools used in the study. Results showed (Rodríguez-Mantilla, Martínez-Zarzuelo, & Fernández-Cruz,
that the institution has a high level of implementation of 2020). As a result, a growing number of educational
ISO 9001; there is only a low level of institutional risk; and institutions are now implementing quality management
the institution's level of performance in the systems (QMS) to improve diverse processes and results in
implementation of ISO 9001:2015 was rated very schools (Fernández-Cruz, Rodríguez-Mantilla, & Fernández-
satisfactorily. There is a very strong and highly significant Díaz, 2019).
relationship between the level of implementation in terms
of planning and design and the institutional performance As part of the expansion of the guaranteed quality
on ISO 9001:2015 in terms of leadership, and operational concept, the ISO 9001: 2015 included standards for risk-
performance; and between documentation development management approaches in its most current version; risk
and operational performance. No significant relationship consideration in institutions becomes proactive rather than
is noted between the level of implementation in terms of reactive to elements that may impact their QMS. Risk-based
planning and design and the level of institutional thinking effectively transforms the entire management system
performance in terms of support, implementation, context into a preventative planning tool (Murray, 2016).
of the institution and support. A very strong and highly
significant relationship is noted between the level of The performance of an institution strongly depends on
institutional risks in terms of reporting/communication the overall quality of the management system which operates
and the level of institutional performance in terms of at schools. A greater level of total education quality in higher
leadership and performance evaluation. Implementation education institutions is essential for providing students with
and reporting or communication. The implementation of the information, skills, and competencies required for success
ISO and the act of reporting the institutional risk after graduation. As a result, every high school and university
assessment were the predictors of institutional requires a functioning and complete quality management
performance in risk management system. Proper system. (Vykydal, Folta, & Nenadál, 2020).
implementation of the Quality Management System can be
achieved by checking its effectiveness through regular The educational benefits of these systems, as well as their
internal and external audits, the conduct of management potential to identify areas for improvement in school
review, and the planned continual improvement would operations and performance, are being studied. Fernández-
greatly affect the institutional performance of the ISO Cruz, Rodrguez-Mantilla, and Daz (2020). The impact of ISO
system. certifications on student satisfaction in Iraq has been
investigated by analyzing ISO standards introduced at Ishik
Keywords:- Assessment, Performance, Quality Management, University. As a consequence, it was discovered that the ISO
Risk, Standards. implementation at Ishik University was successful (Demir &
IJISRT23MAR217 www.ijisrt.com 286

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Guven, 2017). Another study discovered that adopting procedures (teacher commitment, training and education,
ISO:9001 had a bigger than average effect on teaching- teamwork, and continuous improvement) had a statistically
learning processes. Improvements in the subdomains of significant influence on the academic performance of private
tutorials, assessment, and classroom teaching techniques were schools, according to the findings. More precisely, the whole
reported as a result of implementing this QMS (Fernández- quality management dimension of continuous improvement
Cruz, Rodrguez-Mantilla, & Fernández-Daz, 2019). has the greatest impact on academic achievement, followed by
training and education, teamwork, and, ultimately, teacher
Another research was conducted to assess and compare dedication (Sweis, Abualsondos, Magableh, M., Alamayreh,
the impact of implementing ISO:9001 standards and the Sukkari, &Alawneh, 2020).
EFQM model on school communication systems and external
relations. According to the findings, the QMS has a medium- At Al Ma'arif University College, a study examined the
high influence on the communication system and a moderate applicability of ISO 9001: 2015 and the absence of ISO 9004:
impact on the external relations component. However, 2015. After analyzing the findings, a large gap was found
significant disparities in effect levels were discovered between what exists and what is applicable. Furthermore, the
depending on the number of years of implementation and the constraints that prevent the application of the standard were
type of money received, among other things. Furthermore, an identified, and the solutions to overcome them and the benefits
interaction impact was discovered between the kind and size expected to be achieved when applied were given (Idan, 2020).
of schools in terms of their external relations (Rodríguez-
Mantilla, Martínez-Zarzuelo, & Fernández-Cruz, 2020). A study describes the experience and effects of adopting
the ISO 9001: 2008 Standard at the University of Nairobi
Furthermore, a study examines the concurrent effect of a regarding service delivery efficacy, operational performance,
set of predictors of the impact perceived by teachers and automation, implementation obstacles, and related developing
managers of implementing two Quality Management Systems concerns. Significant progress has been made in quality
(QMS): European Foundation for Quality Management institutionalization in university processes, work environment,
(EFQM) and ISO:9001 STANDARDS. The main predictors documentation and record management, customer satisfaction,
of the impact are the position and years of service at the school infrastructure and facilities, use of ICT as the main mover of
(on Level 1 -Subject-) and ownership, school size, and QMS performance improvement, and university ranking. In
implemented (on Level 2 -Schools-), finding that the impact addition, improvement opportunities, as well as crucial
perceived in schools with EFQM was higher (Rodríguez- success criteria, are highlighted. (Muturi, Ho, Douglas,
Mantilla, Fernández-Cruz, & Fernández-Díaz, 2020). Moturi, & Mbithi, 2015).
Research published in Spain evaluates the impact of On the other hand, a study based on the service quality
applying ISO 9001:2008 Standards assessed by Management (SERVQUAL) dimensions of reliability, assurance, tangibles,
Teams and Teachers in four autonomous communities' empathy, and responsiveness coupled with ISO 9001
schools. The most notable findings demonstrate a strong requirement of conformity and non-conformity to determine
influence on dimension management, communication the level of satisfaction of international students on an ISO
medium, learning process, and external interactions, with a 9001 certified institution was conducted in the Philippines.
moderate impact on climate, support and recognition, and The results indicate that the overall service quality of these
satisfaction (Rodríguez-Mantilla, Fernández-Cruz, & universities is moderately satisfactory. Again, the
Fernández-Díaz, 2019). SERVQUAL determinants of Assurance, Tangibles, and
Empathy are moderately satisfied to indicate conformity to
A research is conducted to examine the influence of ISO observation. Reliability indicated conformance with the
QMS adoption on work culture, motivation, and school opportunity to improve. However, responsiveness is slightly
performance. The findings of the study reveal that (1) there are satisfied, which is a minor non-conformity. It requires
considerable changes in organizational behavior, and (2) immediate root-cause analysis and correction and corrective
organizational behavior has a large direct impact on job actions to seek continual improvement (Peprah, 2018).
motivation and school success. It signifies that the application Consequently, there is no better way of understanding the
of QMS ISO has been able to effectively develop an impact of the ISO certification process on academic
organizational work culture in the endeavor of continuous institutions than by examining the implementation level
quality improvement, and behavior changes directly influence (Prasad, Kamath, Barkur & Nayak, 2016).
work motivation and school performance (Giatman, 2017).
Another investigation found convincing results about the The Quality Standard System established for maritime
impact of ISO:9001 standards on teachers' engagement in education posed a great challenge for the university to expand
improving the school's climate, management team conflict the system for the entire university. Misamis University's top
resolution, and family involvement and satisfaction with the management decided to adopt a quality assurance system
school. However, no evidence of an influence on teacher based on ISO 9001:2000 in the School year 2005 and ISO
relations, conflict resolution among staff members, or teacher 9001:2008 in 2010. In 2018, the university qualified for the
satisfaction was discovered (Fernández-Cruz, Rodrguez- latest version of ISO 9001:2015, which focuses on risk
Mantilla, & Daz, 2020). management. However, since its inception, no evaluation has
A research in Jordan evaluated the academic been made to determine the implementation of the system.
performance of ISO: 9001 certified private schools. TQM This prompted the researcher to look into the risk assessment

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and the level of implementation of the ISO 9001:2015 in To test the reliability and validity of the questionnaire, it
relation to the institutional performance of Misamis was pilot tested to a group of faculty, staff and students who
University. were not included as the respondents of the study. The tool was
subjected to reliability test with the following Cronbach’s
II. METHODS Alpha: institution’s control environment (a=0.87), compliance
risk (a=0.85), strategic risk (a=0.82), operational risk (a=0.78),
A descriptive-correlational design was used in the study. and reporting/communication risk (a=0.88).
It was used to define the relationship between variables as
opposed to inferring cause and effect correlations. When the Institutional Performance Questionnaire. This tool
researcher has no control over the independent factors that are determined the level of institutional performance of ISO
assumed to cause or affect the dependent or outcome variable, 9001:2015. It is a modified data gathering instruments taken
the descriptive-correlational approach successfully defines from the Quality Management Checklist. It contains six
one phenomena linked to another (Lappe, 2000). This design construct namely: context of the institution, leadership,
was appropriate for the study to determine the relationship planning for risk management (QMS), support, operational
between the level of implementation of the university's performance, and performance evaluation.
policies and procedures and the university's performance
based on the ISO 9001:2015 Risk Management System. To test the reliability and validity of the questionnaire, it
was pilot tested to a group of faculty, staff and students who
This study took place at Misamis University, Ozamiz were not included as the respondents of the study. The tool was
City. It is a private, non-sectarian institution of learning. For subjected to reliability test with the following Cronbach’s
its quality management system, Misamis University is ISO Alpha: context of the institution (a=0.82), leadership (a=0.88),
certified by Det Norske Veritas, the Netherlands. It offers planning for risk management (a=0.91), support (a=0.81),
varied academic programs designed in a comprehensive and operational performance (a=0.86), and performance
flexible learning environment to meet global challenges and evaluation (a=0.89).
demands for quality graduates; some of these programs have
reached different levels in accreditation status through the The researcher requested approval from the Graduate
Philippine Association of Colleges and Universities School for the conduct of the study. The researcher the sought
Commission on Accreditation (PACUCOA). For ninety years, permission from the Office of the Vice President for Academic
the university has advocated a progressive and dynamic Affairs to allow the conduct the study in the University. After
learning environment through its vision-mission that puts God obtaining the permissions, the researcher personally
as the center of its existence and education as its service administered the questionnaires to the respondents. Retrieval
offering to God and its country. of the questionnaires was done at an agreed time. Using the
Excel, the data were tallied and classified, and the analyses of
The respondents of the study were 60 faculty members data ensued.
and 60 staff of Misamis University. They were selected
through random sampling. The following were the inclusion The study ensured that the research respondents were not
criteria in the selection of samples: (1) has been with the subjected to harm in any way. Respect for the dignity of
university for ten years, (1) actively participating in every ISO research participants was prioritized. Full consent was
9001:2015 internal and external audits, and (3) has given the obtained from the respondents before the study. Protection of
consent to participate in the study. the privacy of the research respondents, an adequate level of
 Implementation of ISO 9001:2015 Questionnaire. This confidentiality of the research data, and anonymity of
tool determined the level of implementation of ISO individual and organizations participating in the research was
9001:2015. It is a modified data gathering instruments ensured. Any type of communication in relation to the research
taken from the Checklist for Implementing a Quality was done with honesty and transparency, and any type of
Management System for ISO 9001:2015. It contains three misleading information, as well as representation of primary
constructs namely: planning and design, documentation data findings in a biased way, were avoided.
development, and implementation. To test the reliability
and validity of the questionnaire, it was pilot tested to a The study used the following statistical tools in analyzing
group of faculty, staff and students who were not included the data gathered.
as the respondents of the study. The tool was subjected to
reliability test with the following Cronbach’s Alpha:  Mean and Standard Deviation.
planning and design (a=0.81), documentation development These was used in determining the level of
(a=0.85), and implementation (a=0.83). implementation and risk assessment of ISO 9001:2015 and the
 Institutional Risk Assessment Questionnaire. This tool institutional performance of the university.
determined the level of institutional risk assessment of ISO
9001:2015. It is a modified data gathering instrument  Pearson Product – Moment Correlation (Pearson r).
developed by Centko, (2017). It contains five constructs This was used to explore the significant relationship on
namely: institution’s control environment, compliance the level of implementation and risk assessment of ISO
risk, strategic risk, operational risk, and 9001:2015 and the institutional performance of the university.
reporting/communication risk.

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 Regression Analysis – C. Level of Institutional Performance
This was used to determine the predictors in the The data on the level of institutional performance on ISO
institutional performance in ISO 9001:2015. 9001:2015 are shown in Table 3. All indicators in measuring
the institution's level of performance in the implementation of
III. FINDINGS ISO 9001:2015 are rated very satisfactorily, indicating that the
institution's overall performance is very satisfactory (M=4.32;
A. Level of Implementation of ISO 9001:2015 SD=0.62).
Table 1 presents the data on the implementation of ISO
9001:2015. As shown in the table, the institution has a high Table 3. Level of Institutional Performance
level of implementation of ISO 9001:2015, as indicated in the Construct Mean SD Remark
overall mean (M=4.06). This means that the top management
has shown commitment and determination to implement ISO Context of the 4.33 0.62 Very
in the institution. Institution 4.37 0.63 Satisfactory
Leadership Very
Data revealed a very high level of implementation in Planning for Risk 4.33 0.61 Satisfactory
documentation development (M=4.21; SD = 0.71) and a high Management 4.24 0.65
level of implementation in planning and design (M=3.84; Support 4.29 0.61 Very
SD=0.73), and in implementation (M=4.12; SD=0.75). Since Operational 4.33 0.61 Satisfactory
the University has maintained a well-established Quality Performance Very
Management System which had been in use since 2003 (ISO Performance Satisfactory
9000:1994) for Maritime Education, and in 2005 for Evaluation Very
university-wide implementation, the University is committed Satisfactory
and determined to implement ISO 9001:2015 to ensure that the Very
QMS is safeguarded against threats and risks. In 2018, the Satisfactory
University qualified for the latest version of ISO 9001:2015.
Overall 4.32 0.62 Very
Table 1. Level of Implementation of ISO 9001:2015 Satisfactory
Construct Mean SD Remark Note. Performance Scale: 4.21-5.00 (Very Satisfactory);
Planning and Design 3.84 0.73 High 3.41-4.20 (Satisfactory); 2.61-3.40 (Fair); 1.81-2.60 (Poor);
Documentation 4.21 0.71 Very High 1.00-1.80 (Very Poor)
Development 4.12 0.75 High
Implementation D. Relationship between the Level of Implementation and the
Overall 4.06 0.73 High Level of Institutional Performance in ISO 9001:2015
Note. Implementation Scale: 4.21-5.00 (Very High); 3.41- Date in Table 4 revealed the relationship between the
4.20 (High); 2.61-3.40 (Moderate); 1.81-2.60 (Low); 1.00- level of implementation and the level of institutional
1.80 (Very Low) performance in ISO 9001:2015. There is a very strong and
highly significant relationship between the level of
B. Level of Institutional Risk of ISO 9001:2015 implementation in terms of planning and design and the
Presented in Table 2 are the data on the level of institutional performance on ISO 9001:2015 in terms of
institutional risk as perceived by the faculty and staff. It can be leadership (r=0.933; p=0.008); and operational performance
noted that there is only a low level of institutional risk (r=0.948; p=0.006); and between documentation development
(M=2.49; SD=1.28). This means that the institution's vision, and operational performance (r=0.915; p=0.010). On the other
mission, and objectives are properly communicated to all hand, no significant relationship is noted between the level of
stakeholders; therefore, everybody is on the same path towards implementation in terms of planning and design and the level
realizing its goals and objectives. The university’s of institutional performance in terms of support (r=0.534;
organizational structure clearly defines established duties and p=0.056); implementation, and context of the institution
responsibilities. (r=0.270; p=0.099); and support (r=0.498; p=0.061). The rest
of the variables of the level of implementation significantly
Table 2. Level of Institutional Risk of ISO 9001:2015 affects the level of institutional performance in ISO
Construct Mean SD Remark 9001:2015.
Institution Control 2.43 1.25 Low
Environment
Compliance Risk 2.44 1.45 Low
Strategic Risk 2.53 1.20 Low
Operational Risk 2.50 1.24 Low
Reporting/Communication 2.54 1.26 Low
Overall 2.49 1.28 Low
Note. Risk Scale: 4.21-5.00 (Very High); 3.41-4.20 (High);
2.61-3.40 (Moderate); 1.81-2.60 (Low); 1.00-1.79 (Very
Low)

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Table 4. Relationship between the Level of Implementation and the Level of Institutional Performance in ISO 9001:2015
Variables r value p value Remarks
Planning and Design and:

Context of the Institution 0.597 0.048 Significant
Leadership 0.933 0.008 Highly Significant
Planning for Risk Management 0.784 0.025 Significant
Support 0.534 0.056 Not Significant
Operational Performance 0.948 0.006 Highly Significant
Performance Evaluation 0.735 0.030 Significant
Documentation Development and:

Leadership 0.600 0.047 Significant
Support 0.866 0.015 Significant
Operational Performance 0.915 0.010 Highly Significant
Implementation and:
Context of the Institution 0.270 0.099 Not Significant
Operational Performance 0.648 0.041 Significant
Note: Probability Value Scale: **p<0.01 (Highly Significant); *p<0.05 (Significant); p>0.05 (Not significant)
E. Relationship between the Level of Institutional Risk and the Level of Institutional Performance in ISO 9001:2015
The test of the relationship between the level of institutional risks and the level of institutional performance in ISO 9001:2015
is shown in Table 5. A very strong and highly significant relationship is noted between the level of institutional risks in terms of
reporting/communication and the level of institutional performance in terms of leadership (r=0.909; p=0.010); performance
evaluation (r=0.993; p=0.001). This means that the wide dissemination of processes within the institution greatly influenced
leadership and the institution's performance in ISO 9001:2015. Furthermore, the complete and accurate information, whether
financial or non-financial, contributed to appropriate decision-making to prevent operational difficulties.
Table 5. Relationship between the Level of Institutional Risk and the Level of Institutional Performance in ISO 9001:2015
Variables r value p value Remarks
Institution Control Environment and:
Compliance Risk and:

Leadership 0.464 0.066 Not Significant
Planning for Risk Management 0.265 0.100 Not Significant
Operational Performance 0.310 0.091 Not Significant
Performance Evaluation 0.333 0.087 Not Significant
Strategic Risk and:

Operational Performance 0.536 0.056 Not Significant

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Operational Risk and:

Performance Evaluation 0.556 0.053 Not Significant
Reporting/Communication Risk and:

Leadership 0.909 0.010 Highly Significant
Support 0.826 0.020 Significant
Performance Evaluation 0.993 0.001 Highly Significant
Probability Value Scale: **p<0.01 (Highly Significant); *p<0.05 (Significant); p>0.05 (Not significant)
F. Multiple Regression Coefficients Predicting Institutional Performance

Multiple regression analysis was used to test if implementation and risk assessment are significant predictors of institutional
performance in ISO 9001:2015. The regression result shows that two predictors explained 41 percent of the variance (R2=0.41,
F=1.252, p=0.028) or the extent of the institutional performance in ISO 9001:2015. Furthermore, it was revealed that implementation
is the highest of the predictor variables, followed by reporting/communication risk. I also implied that other factors outside the
predictors mentioned can further explain the institutional performance in ISO 9001:2015.
Table 6 Multiple Regression Coefficients Predicting Institutional Performance

Unstandardized Coefficients Standardized Coefficients
Factors t value p value
B Std. Error Beta
Constant 4.326 0.342 12.649 <0.01
Implementation 0.356 0.216 0.400 1.734 0.036
Reporting/ Communication Risk 0.362 0.167 0.801 .167 0.032
Adjusted r2 0.41 (41%)
F 1.252
p-value 0.028
IV. DISCUSSIONS The University has implemented the ISO through a

quality management system since 200 (ISO 9000:1994 in
In planning and design, the factors of commitment and 2002; ISO 9001:2000 in 2005; ISO 9001:2008 in 2010, and
determination to implement was explicitly articulated by the ISO 9001:2015 in 2018) and implementation of the QMS is
top management. Certification by ISO plays a major highly visible in the institution. There is a yearly external audit
component in maintaining autonomous status of the of ISO 9001:2015 for certification. Prior to this audit, the
University. In view of this, the management representative is University conducts a management review present the results
appointed is appointed to ensure close coordination with top of audits, status of preventive and corrective actions, follow-
management and ISO register. The management up actions from previous management reviews and solicits
representative coordinates and oversees the progress of recommendations to improve and ensure process performance
implementation and ensures that the quality system is in place. and product conformity. All risks identified in the review are
Quality documentation is ensured as this has been the essence acted on based on the recommendations presented by different
of ISO quality management system. All documents are heads of colleges and offices.
controlled and approved by top management.
Before the external audit, a pre-assessment audit is
At the inception of ISO 9001:2015 in the University, the conducted to ensure that all related standard requirements have
procedures specified in the manual are properly documented been met and all non-conformances have been corrected.
to ensure control of documents and records. Internal quality
audits are conducted within the year to ensure that risks in the The management was convinced that registration and
operations are addressed accordingly. Non-conforming certification would enable the organization to show its
products are identified through corrective and preventive commitment to quality to its stakeholders. Hence,
actions. This is evident in the system which resulted in a very management representatives coordinate and oversee the
high response of documentation development in the progress of its implementation. There is quality system
University. maintenance, awareness training, the performance of gap

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analysis, and the creation of a thorough and documented It is also compliant with the educational qualifications of its
implementation plan. Moreover, the high level of faculty and staff and employs effective strategies in
implementation is evident in a quality management system implementing the institutionalization of instruction.
that is in place. In addition, there is checking of the
effectiveness of the QMS through a regular internal quality The University has a well-defined organizational
audit, the conduct of management review, and the conduct of structure that defines responsibility and accountability. The
pre-assessment audit to ensure that all applicable and related mission-vision-objectives and core values are very well
standard requirements have been met and non-conformances understood and articulated in strategic places in the campus
have been corrected. More importantly, there is a planned and other documents especially in all instructional materials
continual improvement to maintain its effectiveness in the (IMs) used in all classes. The standards of hiring, orientation,
institution. training, evaluation, counselling, promoting, and
compensation are well-defined and documented. Violations
Many companies are adopting Quality Management of expected behaviors and demeanor are not tolerated and is
systems (QMS) to improve efficiency, competitiveness, and part of the organizational culture of the University.
customer satisfaction. The purpose of ISO 9001 is to help
institutions implement and run an effective quality The University adopts the PDCA (Plan-Do-Check-Act)
management system (Purwanggono & Handayani, 2018). By cycle in complying with statutory and regulatory and legal
implementing the requirements of the new edition of the ISO requirements. Compliance risk is low because of the relative
9001:2015 standard requirements, the institution defines all requirements from other external regulatory bodies adopted
the procedures required for the quality management system, and complied with by the University. The CHED minimum
including activities dealing with risks and opportunities standards are complemented with the standards of the
(Sitnikov et al., 2017). Philippine Association of colleges and Universities
commission on Accreditation (PACUCOA), Institutional
A paper discussed factors to support ISO 9001:2015 Sustainability Assessment (ISA) of CHED, Maritime Industry
implementation. The factors assessed are top management Authority (MARINA), the Legal Education Board (LEB), and
commitment, team commitment, training, responsibilities, and the Professional Regulation Commission (PRC) support the
authorities defined, schedule for implementation, quality requirements of ISO 9001:2015.
culture, resource availability, integration between
departments, level of bureaucracy as well as the level of Strategic risks are also low because the institution
awareness regarding the ISO 9001 significance (Almeida et promulgates five-year strategic plans to identify priorities,
al., 2018). Another paper analyzed the problems connected formulate viable strategies, and ensure accountability that
with operations realized within an organization in the ISO impacts realization of priorities and maintain customer
9001:2015 implementation process. For example, an satisfaction. The threats to customer satisfaction such as
organization should plan, implement, and control the interruptions or delay in availability of data, shifts in
processes needed to meet the requirements for providing technology, delay in implementing process or service
products and services. In addition, the organization must improvement, interruptions from technological efficiency or
guarantee that outputs that do not meet their specifications are delay, ineffective portfolios and program controls, are
detected and regulated to prevent unintended usage or addressed appropriately.
distribution. (Wolniak, 2020).
In its operations, risks are controlled or prevented
The implementation of the ISO management system through a Management Information System (MIS) that ensures
standards in the institution helped improve its performance by only programs and data are loaded into the production
specifying repeatable steps that the institution consciously environment in accordance with intentions of top
implements to achieve its goals and objectives and to create an management. Resource allocations are properly managed to
organizational culture that reflexively engages in a continuous sustain competitive advantage and future changes. Key
cycle of self-evaluation, correction, and improvement of personnel and faculty are provided trainings to obtain relevant
operations and processes through heightened awareness of the knowledge, skills, and experiences to achieve the institutions
faculty and staff and management leadership and commitment. objectives. Technology, people, and processes are regularly
Moreover, with the yearly certification process, more efficient reviewed to ensure that they support current and future needs
use of resources and increased capability to deliver consistent of the institution. Access controls are instituted to prevent
and improved services and products are seen in the institution, inappropriate or unauthorized access and use of date or
thereby increasing value to customers and other stakeholders. system.
The data further revealed that the management could The most significant quality of ISO 9001:2015 is in the
manage risks and control its environment. They have the communication process. The study revealed a low risk in
expertise and mindset necessary for oversight responsibility reporting and communication. There are venues for
like scrutinizing activities, presenting alternative views, and information dissemination like the management review,
acting on problems at hand. The institution is also compliant regular administrative and academic council meetings,
with all requirements of the regulatory/legal bodies. It operational plans of colleges and support services offices. The
maintains institutional stability with its accreditation and deans and department heads submit accomplishment reports
certification status, thereby maintaining its autonomous status. by semester to ensure that the operational plans are duly

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accomplished. These plans ensure that funds are used as infrastructures needed for the effective operation of QMS were
intended and approved through the operational plans. Budgets sufficient; the necessary competence for faculty and staff
and plans are realistic as they are resultant of the performance performing the work conformed to the requirements; and that
measures. The systems and processes are sufficient to these personnel understood the quality policies and the
safeguard unintended access to information. No activity in the implications of not conforming with the requirements. In terms
University that makes use of financial and material resources of operational performance, the very satisfactory performance
are conducted without approval of the University President of the institution indicates that adequate actions are in place to
through proper channels. ensure effective planning, implementation, and control of the
processes and the methods used as well.
Risk-based thinking is recognized as an excellent
technique for developing, auditing, and improving quality There is constant communication among stakeholders –
management systems (Ezrahovich et al., 2017). Risk customers and providers, monitoring and reviewing the
management is critical to organizational survival. institution's processes. Control external providers to ensure
Furthermore, enhancing the rate at which the institution's that operations in the institution are carried out under
services change necessitates putting risk management at the controlled conditions. In evaluating the institution's
forefront of the institution's objectives in order to achieve performance, it maintains documented information to see that
sustainability (Ahmad et al., 2017). monitoring and measurement activities are implemented. The
institution then analyzes and evaluates the data, which serves
It is noted that risk-based thinking is an effective tool for as the input to its management review. The output in the
creating, auditing, and improving quality management management review is used to improve the underperformances
systems (Ezrahovich et al., 2017). To address the new of the institution and the effectiveness of the quality
requirements, three transition designs should be prepared: (i) management system.
identifying needs from interested parties, (ii) analyzing
internal and external factors of the organizations to formulate In this study, the level of institutional performance is
relevant strategies and quality objectives, and (iii) registering measured in terms of the six elements of context of the
risks associated with business processes as well as institution, leadership, planning for risk management, support,
organizational strategies (Sari et al., 2017). Risk management operational performance and performance evaluation (Table
plays an important role in organizational sustainability. 3).
Furthermore, improving the pace of the institution's change in
services requires the organization to put risk management on Top management continues to support the QMS and
the main agenda in the institution's objectives to achieve assumes full responsibility of promoting continual
sustainability (Ahmad et al., 2017). improvement of all processes and eliminating risks. The
quality procedures manual and the quality policy manual
In today's competitive world, the institution did not only remain to be the standards and are periodically reviewed for
depend on meeting customers' needs but exceeding their continuing relevance to present needs. The university
expectations. ISO 9001:2015 is designed to involve risk president as the chief executive officer exerts full leadership
management as part of the strategic plan in the University in capabilities to ensure the commitment to the development,
order to prevent, address, or correct its prevalence in the implementation and improvement of the QMS. Directly under
system, thereby ensuring customer satisfaction. the university president is the office of the Quality
Management System that handles all matters relative to risk
This means that in the institution's context, it has a management.
process of monitoring and reviewing its external and internal
issues. The QMS processes are maintained and sustained, and The institution operates in a planned and systematic
there is assurance that all requirements of the standards have manner for any changes effected to the QMS. It implements
been applied in the institution. In terms of leadership, the actions to address the impending risks and identified risks and
management also takes full responsibility for promoting evaluate the effectiveness of actions. The quality objectives
continual improvement of the institution, as evident in their are the guiding posts in ensuring effectiveness of actions.
commitment to the development, implementation, and Quality objectives are measurable, relevant, monitored,
improvement of QMS. Moreover, the management implement communicated, and updated.
actions to address the risks and evaluate the effectiveness of
those actions. The management made sure that planning for The support of top management in the QMS of the
risk management is always done by ensuring that the quality university is evident through documented information in
objectives are measurable, relevant, monitored, defined format, reviewed and approved for adequacy and
communicated, and always updated; implementing actions to controlled to protect from infiltration of unwanted activities or
address the risks; and proceeding with the planned and improper use of resources. Adequate human resources have
systematic manner of any changes in the QMS. defined functions to comply with customer and regulatory and
statutory requirements. Personnel performing specific
Management support is also given to the colleges and functions are trained to conform to specific product
departments by providing them with the needed resources that requirement. Buildings and associated utilities, information
comply with the customer and regulatory and statutory and technology equipment and facilities are sufficient.
requirements. In addition, the management ensured that the Monitoring and measuring resources are available and suitably

ISSN No:-2456-2165
maintained to ensure valid and reliable results in all and staff; and the creation of a thorough and specific
operational processes. documented implementation plan helped a lot in their
leadership performance in their respective areas. These
The institution carries out production and services under comprehensive plans enabled the management to take full
controlled conditions. The office of the QMS is responsible in responsibility for promoting continual improvement of all the
the planning, implementation, control of processes and the institution's processes, resulting in satisfaction among the
methods used; and communicates these to the officers stakeholders. A well-crafted plan and design for the
concerned and reviews them periodically. The different institution's improvement also contributed to a very
colleges and support departments submit a yearly operational satisfactory operational performance. A very good plan,
plan to the QMS Office whose task is to review the operational coupled with a high level of its implementation and control of
inputs for adequacy and adherence to the quality objectives. the process conducted lead to ensuring quality outputs.
This way, the relevance of the plans to the five-year strategic
plan of the university is assured and unprecedented risks may In the same way, a very high level of documentation
be prevented. development results in a very satisfactory operational
performance of the institution. Therefore, in the
In Indonesia, research was carried out to investigate the implementation of ISO 9001:2015, it is imperative that the
impact of implementing the Integrated Management System colleges and departments must document everything they have
(IMAS), specifically the ISO 9001:2015. (Quality). The done in their respective areas to ensure evidence of the
analysis revealed that the installation of IMAS considerably processes that are carried out. In this context, the results
impacted the business performance of the selected indicate that different colleges' and departments' ways of
organizations. It has also been discovered that IMAS has organizing and documenting the quality management system
helped to boost employee awareness, improve the company's processes contribute to their satisfactory operational
image, improve the quality and safety of food items, expand performance of the ISO system.
the pool of new consumers, and allow access to new markets.
Furthermore, IMAS has shown to be an essential system that On the other hand, the implementation in terms of
has raised customer happiness, led to the improvement of planning and design does not significantly influence the
internal organizational structures, improved communication institutional performance in terms of support. Since the ISO
culture in businesses, increased staff productivity, and reduced system has been implemented for quite a time in the
non-compliant goods (Agus et al., 2020) institution, the management has already determined the
needed material and human resources to conform to the
Another study examined the relationship between ISO requirements. The infrastructure needed for the system's
9001 and the operational (productivity, customer satisfaction, effective operation is already sufficient but maybe upgraded
and product quality) and commercial (sales growth, profit rate, from time to time.
and market share) performance of Indonesian automotive
component manufacturing sectors. The study shows that A study determined the effect of implementing the
implementing the ISO 9001:2015 quality management system integrated management system on Quality Performance. The
considerably benefits operational and business performance. results showed that the application of Integration Management
Furthermore, operational success greatly affects business System ISO 9001: 2015 has a significant influence on quality
performance (Nurcahyo & Habiburrahman, 2021). performance, such as increased customer satisfaction index,
Furthermore, a study explored the benefits of implementing customer complaint reduction, reduction of defects, decreased
the ISO 9001:2015 quality management system in various product returns, and reduced cost of quality (Purwanto, Asbari,
industries. The results of the literature review analysis state & Santoso, 2020). Moreover, Fahmi et al. (2021) analyzed the
that implementing the ISO 9001:2015 quality management effect of implementing the ISO 9001: 2015 quality
system can increase productivity, quality, delivery, cost, management system. The study results that the application of
morale, and occupational safety and health in the industry ISO 9001: 2015 quality management system has a positive and
(Kartono & Soediantono, 2022). significant relationship to manufacturing performance.
Another research determined the impact of implementing the
The term 'standards' includes the quality, safety, and ISO 9001: 2015 quality management system on the
efficiency of the business's products or services. ISO 9001 performance of tourism companies in Indonesia. The results of
certification, in particular, depicts the high quality of products this research indicate that the organizational context,
and services. Since the institution has already been certified, it leadership, planning, support, operations, and performance
has established credibility and trust among parents, students, evaluation significantly influence company Performance (Ong
and other stakeholders. In addition, it guarantees that the entity et al., 2020).
meets global standards for education.
The findings of a study confirm the dimensionality of
The data indicates that planning and design greatly affect ISO 9001 viability (as measured by the level of achievement
the management's leadership style and the institution's of the standard's destinations, specifically risk identification,
operational performance. The top management's commitment continuous improvement, non-conformity prevention, and
and determination in the implementation of ISO 9001:2015; customer satisfaction) and reveal its enormous commitment to
the establishment of quality policies and procedures of the influence service organization performance. The operational
institution; the awareness training conducted for the faculty performance and product/service quality of the service

ISSN No:-2456-2165
industries are specifically and essentially impacted by the processes, intending to lower costs, creating new
effectiveness of ISO 9001 (Ahmed, 2017). Although the opportunities, meeting regulatory requirements, and assisting
research cited found that ISO certification had a beneficial organizations in expanding into new markets where clients
influence on corporate performance, several studies suggested demand.
that ISO 9000 certification does not ensure excellent
performance. Integrating ISO 9000 certification with total Results of a study showed that the implementation of
quality management (TQM) is critical to improving corporate Quality Management System ISO 9001: 2015 has a significant
performance. As a result, TQM may be an important influence on quality performance, such as increased customer
supplement to ISO certification. Companies that are ISO- satisfaction index, customer complaint reduction, reduction of
certified should not rely simply on the ISO certification. To defects, decreased product returns, and reduced cost of quality
improve organizational and operational performance, they (Purwanto, Asbari, & Santoso, 2020). Results of another
should incorporate ISO certification with TQM (Okudan & research have emphasized the need to investigate further the
Budayan, 2021). impact of ISO 9001 on company performance in institutions.
(Nurcahyo, & Habiburrahman, 2021).
The results implied that the previously implemented
Quality Management System of the institution had a great The requirements state that "the organization shall
impact on the success of the institution in the implementation determine the internal and external communications relevant
of ISO 9001:2015. By using ISO 9001:2015, the institution to the quality management system." ISO 9001:2015 requires
can benefit from consistently providing customers with high- that an organization shall determine and provide the resources
quality products and services. In addition, the continual needed to establish, implement, maintain, and continually
improvement process ensures that the institution becomes improve a quality management system. In addition, the
more efficient, reduces errors, and maintains a high standard organization must identify and supply the individuals required
of service delivery. for properly implementing its quality management system and
the operation and control of its processes (Wolniak, R. (2019).
The institution's effort to consistently meet or exceed
customer satisfaction can be seen in its high leadership level Proper implementation and reporting/communication are
and operational performance. They managed outsourcing vital in implementing ISO 9001:2015. Communication not
activities, allocated resources to key priorities, provided a only conveys information; it also motivates work, changes
conducive work environment, trained faculty and staff for attitudes, and inspires thought. Without it, prejudices emerge,
effective instruction, and provided hardware and software communications get skewed, and system implementation is
necessary for student learning. Furthermore, the reporting and endangered. Communicating effectively is the best way to
communication risks are also contributory factors in the keep everyone connected and informed about what is
institutional performance in the institution's context, planning happening.
for risk management, support, and operational performance.
Hence, it is important to properly disseminate information and V. CONCLUSIONS
safeguard access to systems and processes to prevent loss of
basic processing capabilities and operational difficulties. The institution's management has shown commitment
and dedication to the implementation of ISO 9001:2015, as
As part of the advancement of the guaranteed quality evident in their very high level of documentation development
concept, ISO 9001: 2015 included standards for risk- and planning, design, and implementation of the system. The
management approaches in its most current edition; top institution complies with all the certification standards,
management places a greater focus on leadership to ensure that resulting in a low level of institutional risk. The processes of
risk management is incorporated into all organizational the quality management system are maintained and sustained,
functions, beginning with governance. In addition, the and the management takes full responsibility for promoting
iterative aspect of risk management is also emphasized, with continual improvement. Its implementation, planning, and
fresh experiences, information, and analysis used to revise design greatly affect the leadership of the management as well
process elements, actions and controls at each level of the as the operational performance of the institution. A very good
process (Björnsdottir et al., 2022). Applying the principles of documentation development also contributes to a high level of
a quality management system and adopting risk management operational performance.
strategies can help the organization sustain its business.
Moreover, identifying at an early stage, the potential risk can The risk of reporting/communication influenced the
have significant results such as eliminating defects, reducing management's leadership and the institution's performance
costs, meeting customer satisfaction, and promoting evaluation. It is important to disseminate information and
organization sustainability (Ahmad et al., 2017). safeguard access to systems and processes properly. Although
Risk is inherent in all aspects of a quality management not all the constructs significantly influence the institutional
system. There are risks in all systems, processes, and performance, only two are considered the predictors –
functions. Risk-based thinking ensures these risks are implementation and reporting and communication risks.
identified, considered, and controlled throughout the design Proper implementation of the Quality Management System by
and use of the quality management system. ISO 9001:2015 checking its effectiveness through regular internal and external
defines the guiding principles that can create efficiencies audits, the conduct of management review, and the planned
throughout the organization by aligning and streamlining continual improvement would greatly affect the institutional

ISSN No:-2456-2165
performance of the ISO system. Moreover, proper reporting Risk. Sustainability, 14(9), 4937.
and communication of the risks in all colleges/departments on https://www.mdpi.com/2071-1050/14/9/4937/htm
the processes of the ISO system contribute to a high level of [6]. Cagnin, F., Oliveira, M. C. D., & Cauchick Miguel, P. A.
institutional performance and develop a sense of owning the (2021). Assessment of ISO 9001: 2015 implementation:
system, thereby supporting the processes. focus on risk management approach requirements
compliance in an automotive company. Total Quality
From the findings and conclusions, it is recommended Management & Business Excellence, 32(9-10), 1147-
that the management continue its practices of planning for 1165.
continuous improvement of the institution to ensure a high https://www.tandfonline.com/doi/abs/10.1080/1478336
level of implementation of ISO 9001:2015. They may also 3.2019.1677151
continue their way of scrutinizing activities, presenting [7]. Cagnin, F., Oliveira, M. C. D., & Cauchick Miguel, P. A.
alternative views, and acting on problems at hand to maintain (2021). Assessment of ISO 9001: 2015 implementation:
a low level of institutional risk. The process of monitoring and focus on risk management approach requirements
reviewing external and internal issues, as well as the quality compliance in an automotive company. Total Quality
management processes, needs to be maintained and sustained Management & Business Excellence, 32(9-10), 1147-
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9001:2015. The administration, the deans, and department 3.2019.1677151
heads may further improve their documentation development [8]. Centko, J. D. (2017). A Report Card for Risk
and planning and design in their respective offices as these Management in Higher Education for Two-Year
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Volume 8, Issue 3, March – 2023 International Journal of Innovative Science and Research Technology

Risk Assessment and Implementation of ISO

Abstract:- Quality has become an increasingly crucial and I. INTRODUCTION

IJISRT23MAR217 www.ijisrt.com 286

IJISRT23MAR217 www.ijisrt.com 287

IJISRT23MAR217 www.ijisrt.com 288

IJISRT23MAR217 www.ijisrt.com 289

Planning and Design and:

Documentation Development and:

Compliance Risk and:

Strategic Risk and:

IJISRT23MAR217 www.ijisrt.com 290

Operational Risk and:

Reporting/Communication Risk and:

F. Multiple Regression Coefficients Predicting Institutional Performance

Table 6 Multiple Regression Coefficients Predicting Institutional Performance

IV. DISCUSSIONS The University has implemented the ISO through a

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