A Critique of the ISO 9001 Quality Management System Standard

This report provides a comprehensive analysis of the ISO 9001 Quality Management System standard. It begins with an introduction to the standard, highlighting its role in promoting sustainable trade and ensuring customer satisfaction. The report traces the origin of ISO 9001, contrasting it with its predecessor, ISO 9000, and emphasizing the shift towards continuous process improvement. It then defines the standard and discusses its levels, including the Capability Maturity Model (CMM) and its five maturity levels. The report delves into the implementation of ISO 9001, emphasizing its integration into management systems and the importance of senior management involvement. It explores the competitive advantages gained through ISO 9001 adoption and its significance in accessing global markets. The philosophy behind the standard, based on eight management principles, is explained, along with the benefits and challenges associated with its implementation. The report concludes by summarizing the key aspects of the ISO 9001 standard and its impact on organizational quality management.

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1ISO 9001 QUALITY MANAGEMENT SYSTEM STANDARD
Table of Contents
1. Introduction............................................................................................................................2
2. Origin.....................................................................................................................................2
3. Definition and Levels.............................................................................................................3
3.1. CMM’s Five Maturity Levels of Software Processes.....................................................4
4. Implementation......................................................................................................................5
4.1. Competitive Advantages.................................................................................................6
4.2. Key to Global Markets....................................................................................................7
5. Philosophy..............................................................................................................................8
6. Benefits..................................................................................................................................9
7. Challenges............................................................................................................................10
References................................................................................................................................11

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1. Introduction
Ic and Yurdakul (2019) states that, developed by the community of the International
Organization for Standardization (ISO), the ISO 9001 series of standards is a quality
management approach that is responsible for promoting sustainable trade in the various
organizations worldwide. The ISO 9001 (Quality Management System – Requirements) is
widely used by the organizations to demonstrate the fact that they manage their business
processes by maintaining the quality of their services as well as their products and provide
confidence to their customers regarding the same. This standard quality of approach helps
them to meet customer satisfaction consistently as well as the applicable regulatory
requirements.
The focus of ISO 9001 series of standards is to improve the processes continuously in
the organization that will help them to gain customer satisfaction as well as a goodwill in the
market amongst its competitors. According to Shaharudin et al. (2018), the organization will
internally benefit at large following ISO 9001 standards because increased profitability in the
market will lead to job satisfaction amongst the employees by salary increment, enhanced
morale support and so on. Thus, the ISO 9001 standards specialises on improvement of the
processes within the organization that will eventually help them to meet the standard quality
of their services and products and a consistency in their deliverable outcomes.
2. Origin
The development of the ISO standards happened to be the brainchild of the technical
committees that comprised of national delegates from various industries, business experts and
responsible stakeholders from government and other reputed organizations. Before the
development of the ISO 9001 series of standards, the ISO 9000 series existed in the business
industry that comprised of certain regulatory standards of the processes, products and

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services. As stated by Fonseca and Domingues (2017), the concern of ISO 9000 was widely
distributed on various aspects such as customer focus, involvement of people, management of
business, implementing effective changes, improving the existing operations and so on. Since
huge areas were covered in ISO 9000 series, the organizations lost their primary focus on
providing efficient customer services by improving the service and product quality on their
end.
Previously, the organizations by following ISO 9000 standards used to patch over
their weak points before annual meetings in the conferences and never bothered about
attending the concerning issues that existed within their internal processes. According to
Kansal, Singhal and Khurana (2017), since the inception of the family of ISO 9001 series of
standards, the organizations understood the importance of improving their business processes
to a certain standard that will help them to gain quality in their products easily. Improved
processes in a business will lead to quality solutions and an increase in the customer base for
the organizations. Hence, the rise in ISO standard from 9000 to 9001 helped the organizations
to focus on continuous improvement in the internal operations.
3. Definition and Levels
The Capability Maturity Model (CMM) is a business model that is incorporated by
the US government that specifically focuses on the evolution of the software developmental
process of an organization. The Software Engineering Institute (SEI) developed the model of
CMM being sponsored by Department of Defence in United States in their research and
development centre and promoted it in the business industry for effective improvement in the
business processes. Abuhav (2017), states that the CMM model that was established in 1984
aims to detect the software engineering issues and address them significantly by
incorporating software engineering methodologies in particular. SEI was determined to

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optimize the processes in a business by maintaining the software-based systems for the
Defence unit.
Since CMM incorporated the usage of software engineering methodologies, the
Software Engineering Institute allowed for its industry wide adoption after the ISO 9001
series of standards. Basir et al. (2017) specifies that the ISO 9000 standards specifically
focused on the effective and quality system for manufacturing and services. On the other
hand, the CMM steps specifically focused on the software development and its maintenance
in the industry. Hence, it was evident from their approaches that the ISO 9001 maintained a
minimum level of acceptability in their software processes while the CMM focused on a
regular improvement of the software processes to gain quality in business.
3.1. CMM’s Five Maturity Levels of Software Processes
The Capability Maturity Model as developed by the SEI in the year 1984 comprised
of the following five steps or the five levels of maturity in the software processes. These are
named as the initial level, the repeatable level, the defined level, the managed level and the
optimising level.
Titov et al. (2016) states that the initial level, as the name suggests refers to the
starting of the processes when it is absolutely disorganized and chaotic in nature. Gaining
success at this stage is almost impossible and is achievable only by personalized effort of the
individuals. At this stage, the processes are undefinable and hence cannot be replicated
further.
The basic project management techniques are implemented at the next level known as
the repeatable level. The processes that are established at this level are established, designed
as well as documented. Hence, the success can be repeated at this level due to the availability
of the resources.

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The next level that is more advanced is known as the defined level. At this level, the
organizations has already developed his own set of standard software systems that are well
integrated, defined and documented.
Torrecilla-Salinas et al. (2016) states that the managed level is the more advanced
level than the previous one because at this stage, an organization has not only a well-defined
process in their system, but also they have the framework to monitor and control the
processes. The organization collects data and performs data analysis at this level to supervise
the functionality of the software system.
The final level of CMM model is the optimizing level, where the processes are
continuously under monitoring and supervision such that the current processes are advanced
to a better version and optimum solutions are obtained from the processes.
4. Implementation
According to Franceschini, Galetto and Mastrogiacomo (2018), since the standards of
ISO 9001 are established the companies had a perception that a particular individual or a
group within the company will be responsible for maintaining the standards and they will
carry out a separate set of activities to follow the regulations. The organizations at first failed
to understand the framework of ISO 9001 and considered it a bunch of documents of
compliance that will be passed to a third party for audit process. However, the organization
should have included ISO 9001 to be a part of their management system platform.
To overcome this problem, the companies should include the ISO 9001 standards as a
part of their managerial procedures. To implement the standard quality management process
effectively, the senior management level of the organization should consider ISO 9001 as a
by-product of their system and not as an objective. According to Anttila and Jussila (2017),
the standard quality management approach does not focus on faster delivery of products to

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the customers. It ensures that the requirements of the customers are met by optimal
development of the products. This involves proper selection of suppliers that will serve
standard items according to the client’s requirement.
As stated by Willar, Trigunarsyah and Coffey (2016), the senior managerial body of
any organization should responsibly administer the implementation of the ISO 9001. The
following steps can achieve the development of the quality management system within the
organization:
 Establishing an effective communication at all levels of the organization to make
everyone aware about the importance of achieving customer’s standards as well as the
regulatory requirements.
 Demonstrating the policy of quality.
 Assuring that the quality objectives are determined.
 Obtaining reviews and feedback from the management about the processes.
 Confirming the availability of abundant resources required for developing the
products.
Hence, the senior management executives should create a vision and imply it to the
employees of the organization to foster a culture of continuous improvement in the
processes of their systems.
4.1. Competitive Advantages
The management of any organization in the current age is always under peer pressure
to improve their process as well as product quality through continuous innovations in their
strategies. By doing so, it will help them to gain satisfaction of the customers and the other
stakeholders of the organization. Natarajan (2017), states that adopting international
standards of quality management, the companies take a new approach towards their processes

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to attain a global standard. If the organizations adopt the ISO 9001 standard of managing
quality, it will not only take care of the products that are not manufactured properly, but take
care of the manufacturing unit itself such that it is able to produce robust products.
4.2. Key to Global Markets
According to Zimon (2016), the ISO 9001 series of standard regulations that was first
established in 1987 and revised in 1994 was to ensure quality management and quality
assurance of the processes in organizations. The regulations were not specified for any
particular industry or products and services and hence could be applied to any kind of
industry for proper documentation and defining of their processes. As per a survey that was
conducted in the year 1995, more than 130,000 mobile companies have registered to the ISO
9001 standards of quality management.
The companies that follows the ISO 9001 standards are not necessarily a part of the
ISO 9001 registration process. The companies can adopt a third party in between who will be
responsible for verifying that the processes in the company are in compliance with the
requirements of the customers and the statutory regulations. The third party will conduct the
audit in all the systems of the organization and check whether they are capable of meeting the
standards to provide quality services to its customers.
The companies throughout the world has started adopting ISO 9001 quality
management approach because it has helped them in various aspects. Casolani, Liberatore
and Psomas (2018) states that by following the standards, the firms have been able to gain
trust amongst its customer base that they are doing quality business in the market and will not
compromise with their standards under any circumstances. Moreover, it has helped them to
document their processes well, increase quality awareness amongst the employees and
enhanced productivity to a maximum level. Thus adopting ISO 9001 standards has helped the

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organizations at large to gain the pace of competition in the market and establish a high
margin of goodwill for their customers.
5. Philosophy
The ISO 9001 series are designed to detect lacks and issues in the current processes
and improve quality in them such that the product outcome is robust in quality. These
standards are not particularized for a specific industry or organization. Rather, any
organization across the world can follow these set of rules and regulations to improve quality
in their business models. According to Bravi, Murmura and Santos (2019), if the managerial
body takes the responsibility of consistently improving the processes in the system, there will
be an automatic rise in the quality of the products. This rise in quality will not happen
overnight, but will be implemented gradually with the change in the processes.
Hence, the Standard is based on the eight principles of management that helps in
improving the processes of the systems. The first principle is based on the customer
satisfaction where the standards are set according to the requirement of the customers. The
organizations should look into the fact that the customers are benefitted by the optimum
quality of services. The second principle is to provide optimum quality of leadership to the
employees of the organization that will help them to make improvisations in the quality of
their systems. The third principle is to engage the employees in continuous monitoring of the
quality of the services.
The fourth principle is to maintain a process approach in improving the quality of the
systems. Heras-Saizarbitoria (2018), states that this process approach is to maintain a
significant methodology to enhance the systems in their quality. The fifth principle is to use
the system approach in managing the changes while improving the quality in the systems at
an advanced level. The sixth principle focuses on continuous improvement of the processes

9ISO 9001 QUALITY MANAGEMENT SYSTEM STANDARD
such that the issues minimizes with time. The seventh principle focuses on making decisions
based on the facts and data, thus involves data analysis on various aspects. The last principle
is about maintaining beneficial relationships with the suppliers such that they provide
potential items for manufacturing of the products.
6. Benefits
There are both internal and external benefits that are associated with the
implementation of the ISO 9001 series of standards within an organization. According to
Pratama et al. (2018), the major benefit is about cost-saving activities that are carried out due
to the improvement in the processes of the companies. The organization can implement
changes in many of the processes and make it automated by the managing information
systems. This automation of the processes will lead to streamlining of the operations and
reduce the functionality of three departments into one. The organizational culture will also
become harmonious due to the efficiency in the processes with similar elements. This
information can also be shared amongst other organizations in the world. In addition, the
similar processes in various organizations can be reduced to one single process thereby
reducing the relative cost for the organization. Communication and paperwork can also be
streamlined due to the implementation of ISO 9001 in the organizations.
If a certain company itself is registered to the ISO 9001 certified standards, it can
reduce the costs conducted for the third party audit systems. The amount that has to be paid
for the audits in the processes will not be required anymore due to the adaptation of the
standards within the system. The major benefit incorporated is the increase in the profit
margins of the organization due to the enhancement of the processes. Fonseca et al. (2019)
states that the employees will be highly benefitted from these standards because the brand
image of the company will lead to increase in the sales and thus an increment in the salary.

10ISO 9001 QUALITY MANAGEMENT SYSTEM STANDARD
Hence, they will be motivated to increase their enthusiasm for their job responsibilities and
accomplish their work successfully in the organization. The other benefit is that adopting
these standards leads to reduction in the waste and proper waste management. The end result
will be the sustainable development of the organization incorporating reduction in the
damage of the equipment as well as product loss.
7. Challenges
The ISO 9001 certification incorporates various benefits, although there are numerous
disadvantages associated with the quality management methodology. Firstly, there can be
lack of financial resources to meet the standards of the ISO 9001 regulations in the business
processes of the system. In addition, there might be lack of support from the stakeholders to
implement the improvisations in the organizational processes. Fuchs, Aghajanzadeh and
Therkelsen (2018) emphasizes that if the internal stakeholders show least interest, there will
be a lack of management and time in implementing the changes for the best interest of the
organization. The revolutionary changes might bring benefits in the processes but employee
turnover will be a big issue associated with the implementation of ISO 9001 in the
organization. If the employees find it difficult to adjust with the new improved processes due
to lack of education or training, it might lead to hamper in the productivity of the
organization. According to Dutta and Chakrabarti (2018), there might be complexity in the
systems too for which the employees can face various problems. Hence, the organization
needs to assess all the aspects before implementing the ISO 9001 series of standards in the
company.

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References
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Excellence, 28(9-10), pp.1090-1105.
Basir, S.A., Davies, J., Douglas, J. and Douglas, A., 2017. The influence of academic culture
on quality management system ISO 9001 maintenance within Malaysian
universities. Journal of Higher Education Policy and Management, 39(3), pp.320-340.
Bravi, L., Murmura, F. and Santos, G., 2019. The ISO 9001: 2015 quality management
system standard: companies’ drivers, benefits and barriers to its implementation. Quality
Innovation Prosperity, 23(2), pp.64-82.
Casolani, N., Liberatore, L. and Psomas, E., 2018. Implementation of quality management
system with ISO 22000 in food Italian companies. Calitatea, 19(165), pp.125-131.
Dutta, P. and Chakrabarti, U., 2018. Cost Benefit Analysis of a Roof Top Solar PV System at
a Domestic Apartment in Kolkata.
Fonseca, L. and Domingues, J.P., 2017. ISO 9001: 2015 edition-management, quality and
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Fonseca, L.M.C.M.D., Domingues, J.P., Baylina, P. and Harder, D., 2019. ISO 9001: 2015
adoption: A multi-country empirical research. Journal of Industrial Engineering and
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