SHS Web of Conferences 49, 01008 (2018) https://doi.org/10.

1051/shsconf/20184901008
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Effectiveness analysis of ISO 9001:2015

implementation at manufacturing industry
Ahmudi1*, Bambang Purwanggono1, Naniek Utami Handayani1
1
Industrial Engineering Department, Faculty of Engineering, Diponegoro University, Jl. Prof.
Soedarto, Tembalang, Semarang, Indonesia

Abstract - Globalization era requires many companies to improve service

quality and resource management capabilities in order to gennerate public
confidence in the products and commitments offered. The quality
improvement program is contained in Quality Management System
(QMS). QMS is developed in ISO 9001 standart certification.ISO 9001 is a
standard that contains quality management system requirements issued by
the International Organization for standarization (IOS). Companies that
become the obyect of research is PT Sejahtera, this company is engaged in
manufacturing.the company suffered several losses in the form of
withdrawal of order from customer. Besides that happened also complaint
from customer will product which yield not according to standard which
have been approved. This research aims to evaluate the effectiveness of
ISO 9001: 2015 implementation at PT. Sejahtera. The method used is Gap
Analysis. Calculations on gap analysis use checklists made based on
requirements of ISO 9001: 2015.the result of calculation using checklist
will show how big the effectiveness of PT. Sejahtera in implementing ISO
9001: 2015
Keywords: Industry,Gap Analysis, ISO 9001: 2015, Quality Management
System.

1. Introduction
The globalization era requires many companies to improve service quality and resource
management capabilities in order to generate public confidence in the products and
commitments offerred [1]. To obtain public trust is required strategy of product quality
assurance. Quality management can be run through Total Quality Management (TQM)
because according to Feigenbaum [2] quality is an important joint that determines the
success or failure of a business in today’s market-oriented quality achievement, the quality
itself is not the field of key business strategy and an important factor in business strategy
planning.
To improve efficiency, competitiveness and customer satisfaction, many companies are
adopting Quality Management System (QMS). QMS is widely developed in ISO 9001
standard certification. The purpose of ISO 9001 is to help companies to implement and run

*
Corresponding author: [email protected]

© The Authors, published by EDP Sciences. This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0
(http://creativecommons.org/licenses/by/4.0/).
SHS Web of Conferences 49, 01008 (2018) https://doi.org/10.1051/shsconf/20184901008
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an effective QMS by enhancing the company’s ability to design, produce and deliver
quality products and services. Based on Fonseca (2015) there are already more than one
million companies in the word that have achieved ISO 9001 standard certification. It shows
that ISO 9001 certificate gives advantages to internal company, in the form of product
quality and good company performance [3]. Jan and Lin on Psosmas [3] implementing ISO
9001, have a direct positive impact on operational performance. From a customer
perspective, ISO 9001 implementation creates a positive sentiment from customers toward
the manufacturing industry, and encourages customers to provide long-term support, and
increase customer satisfaction and loyalty [3].
This research was done at PT Sejahtera which was established in 2011 is a company
engaged in manufacturing false eyelashes, 100% of its products are exported abroad
including America, Europe, Asia and Afrika. Although it has been implementing ISO 9001
since 2013, there are still complaints from customers regarding the quality of the products.
The products are not in accordance with the approved standards. This study aims to analysis
and evaluate the effectiveness of ISO: 2015 implementation by using gap analysis. The
output of this research is to input the evaluation of Quality Management System (QMS) to
top management so that the decision will be taken on target so that complaints from
customers can be done well and quickly.

2. Literature Review

2.1 Definition of ISO 9001

ISO 9001 standard is a standard that contains requirement related to the quality
management system issued by IOS (International Organization for standarization). ISO
9001 standard is a standard management requirement and is not a product specification
standard. As a standard of management requirements. The contents of ISO 9001 is a series
of requirements clauses that ensure consistency of management processes related to quality
in a system. The article on ISO 9001 contain what should be done for organizations that
want to implement and build a management system that explains how to conduct a series of
activities that are specific to each organization [4].

2.2 Quality Management System ISO 9001: 2015

ISO 9001: 2015 is the result of a five-year revision of ISO 9001. The revision process of
ISO 9001: 2015 was started by ISO/Technical committe (ISO/TC 176) aimed at ensuring
international standards. ISO 9001: 2015 reflects changes in an increasingly complex and
dynamic environment. ISO 9001: 2015 consistens of ten clauses, namely the two main parts
and the attachment located in clause zero to clause three and the part of the conditions
contained in clauses four to clause ten. This clause is designed according to the structure in
annex SL, which is a High Level Structure (HSL) which is the same basic reference for all
management system structure published by IOS [5]. The clauses of ISO 9001: 2015 are:
scope, normative references, term and definitions, organizational context, leadership,
planning, support, operational, job evaluation and improvement.

2.3 Risk Based Thinking

What's new with ISO 9001: 2015 is the explicit requirement of risk-based thinking to
support and improve understanding and application in process approaches that already exist
in previous versions of ISO 9001 standard [5]. Risk management is a process to identify the

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hazards that exist in the business as well as the choice of ways to determine the methods
and techniques used to protect the business from such hazards. The process of risk
management is the identification of risk, measurement, risk control and risk mitigation [4].

3. Research Method
The research method used in this research is descriptive method. This method is used to
describe something that is happening at the present moment. Descriptive method is also a
study to make improvements to the current conditions that are deemed necessary to be
improved.

3.1 Gap Analysis

Gap analysis has a sense of the current state and the desires or conditions of purpose and
the cause of the gap between current condition and purpose conditions [6]. By doing a gap
analysis, we can identify what we need to bridge the existing gap [7]. The first step of this
tool is to develop a gap analysis checklist that serves to identify gaps between written
procedures and processes performed. This checklist is based on the requirements of ISO
9001: 2015. To facilitate the analysis of each clause it is given an assessment indicator on
each clause. Once clearly known about the gap (gap) in the company, then steps can be
taken to reduce the gap.
a. Score 1: if the company does not understand what is needed and does not do so.
b. Score 2: if the company understands the importance of the activity but does not do it.
c. Score 3: if the company has documents but has not been applied or done but not
recorded.
d. Score 4: if the company does the activity but is not consistent
e. Score 5: if the company is doing well (done consistently)

3.1.1 Checklist Assessment

Checklist Assessment by respondents based on current organizational conditions. The

respondents chosen were the respondents who had enough competence. Assessments made
under the scoring conditions described above.

3.1.2 Gap Assessment

Gap assessment aims to see how big the gap is in the company. The percentage value is
obtained by summing the score per variable and dividing it by the maximum value in that
variable. The smaller the gap is, the better. Table 1 shows the percentage range of gap
value.

3.2 Research Steps

To get solution of problem which under study required steps that must be passed so that
research can be done systematically. The steps undertaken in the research are as follows:
1. Preliminary studies
PT Sejahtera got complaint order from customer because standard order was not in
accordance with which have been approved. This has an impact on recall order
from customer.
2. Research purposes

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Evaluate the effectiveness of ISO 9001: 2015 implementation and provide

recommendations for improvement of ISO 9001: 2015.
3. Literature review
Quality Management system (QMS), ISO 9001: 2015 and Gap Analysis
4. Collect data
Interview and observation
5. Result and Analysis effectivity of ISO 9001: 2015 implementation
6. Conclusion

Table 1. Percentage range of gap value

Presentation Descriptions
100% Work procedures and requirements are well executed

91% - 99% Work procedures and requirements are run but not consistent

76% - 90% Some work procedures have not been executed but other requirements
are well executed
51% - 75% Many work procedures have not been executed but some requirements
that do not require working procedures have been applied

0% - 50% Very poor implementation. Companies need to understand and review

the implementation of QM ISO: 2015 because it is still far from the
requirements

4. Result and Analysis

4.1 Collect Data

Primary data obtained by conducting interviews and quesionnaires whose contents are
checklist based on ISO 9001: 2015 requirements. The questionnaire is filled by each
department head that exist in the company. The department involved are HRD, marketing,
purchasing, inventory, production, PPIC, IT, QC and QA.

4.2 Data Processing

The result of gap analysis implementation of ISO 9001: 2015 at PT Sejahtera using
checklist based on ISO 9001: 2015 requirement. Evaluation is done based on the results of
questionnaires filled by each department head of company. The clauses assessed are clause
4 to clause 10. The assessment results are shown in the Table 2 and Table 3.

5. Result and Analysis

5.1 Analysis of Organization Contect Clause

Clause organizational contect get value 87%. The means that some work procedures have
not been executed but other requirements are well executed. The company’s constraint to
clause 4 is the lack control from management representative regarding quality management

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system implementation. Table 4 is the result of gap analysis performed of organization

contect clause.

Table 2. Gap Analysis Result

(Source: Data Calculations Result of Researcher )

Table 3. Percentage Gap Analysis Result

(Source: Data Calculations Result of Researcher)

Table 4. Recap of Organization Contect Clause

(Source: Data Calculations Result of Researcher)

5.2 Analysis of Leadership Clause

Based on gap analysis for leadership clauses get value 83%. This shows the working
procedure has not been fully implemented. Constraints faced is the focus on improving
customer satisfaction has not been maintained well in addition to the quality policy is not
fully understood until the operator level. Table 5 is the result of gap analysis in the
leadership clause.
Table 5. Recap of Leadership Clause

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(Source: Data Calculations Result of Researcher)

5.3 Analysis of Planning Clause

Planning clause get value 84% indicating that the company has not been consistently
running the work procedures that have been made. The constraint encountered is that the
actual achievement of the implemented quality management system is not in accordance
with the desired plan. Table 6 is a recap of percentage value of planning clause.

Table 6. Recap of Planning Clause

(Source: Data Calculations Result of Researcher)

5.4 Analysis of Support Clause

The support clause get value 82%. This value is the same as with previous clause result that
the co mpany has not consistently run the working procedure. The constrains faced in
clause 7.2 is the worker’s competence to job specialization has not been well defined by the
company. Besides that quality policy, quality objectives are not well understood by the
workers. Table 7 is a recap of percentage value of support clause.

Table 7. Recap of Support Clause

(Source: Data Calculations Result of Researcher)

5.5 Analysis of Operational Clause

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The operational clause obtain a gap 94%. This means that many work processes and
requirements are run but not consistent. Table 8 is the result of gap analysis performed at
the operational clause.

Table 8. Recap of Operational Clause

(Source: Data Calculations Result of Researcher)

5.6 Analysis of Job Evaluation Clause

The evaluation clause get value 93%. Indicating that work procedures and requirements are
executed but not yet consistent. Table 9 is the result of work evaluation clause.

Table 9. Recap of Work Evaluation Clause

(Source: Data Calculations Result of Researcher)

5.7 Analysis of Improvement Clause

The improvement clause get value 88%. This means companies still ignore some working
procedures that have been made so that still need to be repaired. The constrains faced in
clause 10.1 where in case of incompatibilty, the company’s follow up to take action is still
not maximal so often found complaints from customers in the same thing. Below table is
the result of improvement clause percentage.

Table 10. Recap of Improvement Clause

(Source: Data Calculations Result of Researcher)

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5.8 Analysis of Risk Management

Based on interviews with operational managers and some managers, some risks may be
found in the company. The risk are mixing of knitting material on tiplash process. Chemical
radiation on dye process, process error on packaging departement. The company has
actaully set rules to always use personal protective equipment for dyeing process., but the
awareness of operators to use self-protective equipment that has been provides is still low.
Working prosedures have also been attached to each part of the work, but the accuracy of
worker who are still lacking.

6. Conclusion
The results of overall gap analysis can be concluded that the effectiveness of ISO 9001:
2015 implementation is in the range 82% - 94%. This means that there are some work
procedures not yet executed but other requirements run well. Constraints facing the
company in running the quality management system ISO 9001: 2015 are less control from
management representative regarding quality management system implementastion
(Clause 4), focus on improving customer satisfaction has not been maintained well besides
quality policy not fully understood until operator level (clause 5), implements the quality
management system, the desired outcomes are not in accordance with the target (clause 6),
worker's competence to job specialization has not been well defined by the company.
Besides the quality policy, quality objectives are not well understood by workers (clause 7),
if there is a discrepancy, follow-up company to take action is still not maximal so often
found complaints from customers in the same (clause 10).

References
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