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Quality Management System Standard’s Critique


Purpose – This paper aims to critique the ISO 9001 standard and prove the idea that it remains the general guideline that can be adapted specifically to promote improved results.

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Design/methodology/approach – This qualitative research based on assessing the advantages and disadvantages of applying the ISO 9001 standard includes the experimental method of evaluation with a literature review.

Findings – ISO 9001 contributes to increasing productivity in large enterprises and is not very effective in small companies where governing principles do not require many efforts and strategic development. The given standard has a positive impact on organizational processes and product quality.

Practical implications – Large companies can use the analyzed framework to improve their results and achieve the increased effectiveness of essential processes; small enterprises can adopt some principles to develop governing systems.

Research limitations/implications – The paper is limited by the lack of information about the ethical aspects of ISO 9001 standards’ implementation and their impact on final results.

Originality/value – The paper explores the important framework for the improvement of companies’ functioning and analyses both negative and positive perspectives on the offered model.

Keywords – Service quality, Performance, ISO 9001 standard, Organization, Company, Model, Quality management, Effectiveness.

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Paper type – Research paper.


The ISO 9001 Quality Management System has become a gold standard of certification to be achieved amongst businesses. Its main objective is to enhance quality management in products and services, but many businesses attempt to use it as a marketing tool without committing to change. The system which has existed for several decades has faced criticisms despite universally considered as important for implementation.

This article will consider the elements and purpose of ISO 9001, examine common criticisms of the standard, discuss its viability in the context of modern quality management and international business environment, and research the application of this model to enterprises of different sizes. Despite some shortcomings, ISO 9001 remains an effective approach for quality management if implemented correctly, focused on inherent improvement in a business rather than superficial certification purposes, and utilized in an appropriate working environment with relevant coordinative strategies and development plans.


ISO 9001 is an internationally recognized Quality Management System (QMS) standard by the International Organization for Standardization. ISO developed these standards as tools to address a variety of quality management aspects by guiding organizations who desire to enhance the quality of their products and services to consistently meet customer and regulatory requirements. Effectively ISO 9001 can be adopted by any type of organization, regardless of its size, operational capacity, or industry.

The standards are built on a specific set of seven quality management principles such as customer focus, leadership, engagement, process approach, improvement, evidence-based decision making, and relationship management (International Organization for Standardization 2015). The QMS is meant to integrate the internal processes of an organization with the intent to modify processes for effective project completion. This process-based QMS allows companies to identify, measure, control, and improve several core business processes which lead to enhanced business performance (International Organization for Standardization n.d.)

The ISO 9001 standards are aimed at “prevention of non-conformities, continuous improvement, and customer satisfaction” (Psomas & Antony 2015, p. 2090). They are not only an initial step to adapting to quality requirements but also serve as an essential framework for the improvement of QMS effectiveness, which can be defined as the extent to which target objectives are achieved (Psomas & Antony 2015). The most recent iteration of ISO 9001:2015 sets out criteria for QMS which can be used by a business to achieve certification.

Certification means that a company has met all the requirements outlined in ISO 9001 as it evaluates whether the organizational QMS is appropriate and effective. In turn, this forces leadership to identify and implement improvements.

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Continuous improvement is a key principle of ISO 9001 standards as certification is meant to assure customers that they are working with a business delivering consistent performance and receiving a high quality of products or services that will meet their individual and industry requirements. Despite the challenge of achieving ISO 9001 certification, the company will benefit significantly from internal and operational levels from improved employee satisfaction and morale with enhanced and efficient outcomes (British Standard Institution 2019).


Purpose and Goals

Regarding the existing controversies related to the discussed issue, the main purpose of the given research is to critique the ISO 9001 standards and prove the idea that the enterprises of differential production sizes can benefit differently from utilizing this model. Several tasks are to be set to achieve the stated research goals. The introduction or the given purpose presupposed the formulation of the following objectives:

  • to analyze the ISO 9001 standard and outline its main aspects;
  • to assess the existing advantages and disadvantages of the suggested framework;
  • to evaluate the effectiveness of the standard regarding its functioning in the organizations of different sizes;
  • to discuss major findings;
  • to give recommendations and possible implications of the ISO 9001 standard.


The investigation of the ISO 9001 standard can be a challenging issue because of the existence of opposite perspectives on the given framework and disputes about its effectiveness in the modern business environment. For this reason, the utilization of an experimental qualitative study may be considered the methodology to test all the given assumptions concerning the influence of the size of enterprises on the success of the standard’s application.

As a tool for an evaluation picture, a literature review will be conducted where the key findings from different academic resources will be given. Further, discussion and comparison will follow to prove the proposed theory of difference and achieve the basic research objectives. Ultimately, based on the findings, recommendations will be made concerning the potentially effective use of the ISO 9001 standard in practice.

Literature Review

The key indicators of business success are customer satisfaction, profitability, and market leadership which depend on the quality of products and services. The global tendencies are focused on fully meeting customer expectations regarding quality. However, the definition of quality often meant different things dependent on industry or geographic location. The International Organization for Standardization (ISO) was effectively created as a global agency to create international standards for quality such as the ISO 9001 which deals with fundamentals of QMS and requirements that have to be met by organizations to fulfill them (Lushi et al. 2016).

Standards are created to improve efficiency and performance in an organization. These variables that should be in place to determine whether an organization is performing adequately compromise the fundamentals behind ISO 9001 which are an organizational performance standard. The performance measures, critical indicators, and metrics are fundamental to providing measurable mechanisms to determine success and expectations.

ISO 9001 is a QM paradigm that has had the biggest contribution to developing international standards for organizational practices. For successful countries and businesses, ISO 9001 can serve as a stimulant to improve and achieve recognition. Meanwhile, less developed countries and companies can use ISO 9001 as a source of information to access knowledge areas where they lack expertise (Ochieng, Muturi & Njikia 2015).

Empirical data on the effectiveness of ISO 9001 varies, but there is a general belief that the standards benefit organizations, particularly those less developed or lacking in-house QMS that many global corporations have. In terms of indicators such as net profit and turnover, there are no statistically significant differences. However, ISO 9001 has a positive influence on return on assets (ROA), which improves performance (Ochieng, Muturi & Njikia 2015).

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Furthermore, the implementation of ISO 9001 sees in the improvement of product and service quality, operational performance, financial performance, and market performance, both in terms of empirical data and qualitative observation (Psomas & Pantouvakis 2015). Therefore, ISO 9001 adoption leads to widespread company progress and creates a culture of continuous improvement.

Common Criticism

Despite its status as an international standard for QMS, ISO 9001 has become a subject for discussion amongst management in international business and various industries. There is a myriad of criticism aimed at the standards and certification process. Some of it is opinionated, based on misinformation, while others highlight legitimate concerns which should be addressed in future iterations of the standards. Common criticisms of ISO 9001 will be thoroughly discussed in this section.

Poor Applicability to Industry

There are arguments that the ISO 9001 standards do not accurately follow the business development of organizations and social trends. The standards do not reflect the realities of the ever-changing economic environment and introduction of new technologies which have significant impacts on product characteristics with their development and manufacturing processes (Anttila & Jussila 2017). The supposedly outdated and inapplicable nature of the standards is unable to compete with in-house QMS of large organizations which are more advanced than the general inferiority of ISO 9001.

It can be argued that many companies are forced to register for the certification by the market rather because the standards are appropriate or applicable to their business or even industry. As a result, the standards interfere with working operational processes and can potentially result in worse quality than before implementation. Furthermore, the vagueness of the standards creates confusion since they are meant to be universal, but different types of businesses (for example, food production and engineering firms) cannot effectively use similar documentation.

Enterprises’ Size

The application of the standards under consideration in different companies may have differential consequences in terms of the size of enterprises. According to Ochieng, Muturi, and Njikia (2015), those organizations where strong strategic leadership principles are maintained can utilize the ISO 9001 successfully and efficiently due to a wide range of tasks and production objectives. As a rule, these are large corporations that have broad prospects for development and forging partnerships.

Based on the data provided by Anttila and Jussila (2017), in small organizations where situational management is promoted, it may be difficult to implement the provisions of specific standards. Furthermore, the documentation developed for each industry sector is unique but is to meet ISO 9001 standards, with minimum guidance on how to do so (Sfakianaki & Kakouris 2018). Therefore, when assessing the scope of using relevant certification materials, it is necessary to take into account the principles of workflow control and such activity aspects as the volume of production and enterprise’s capacity.

Compliance and Certification

The ISO 9001 is a set of general guidelines and does not prescribe a technical aspect to quality management but only offers a QMS perspective. Therefore, a company which was offering low-quality products may continue to do so, except the standards provide a more efficient way. Therefore, the system has loopholes and does not ensure compliance with quality management or guarantee a high quality of products that many believe that it does.

In some countries such as China which is a leading manufacturer, there are inherent concerns about the reliability and credibility of the ISO 9001 certification as it is relatively easy to fake or circumvent the requirements (Heras-Saizarbitoria & Boiral 2019). If this documentation is dominant in all the areas without exception, restrictions will arise from the fact that enterprises will not have the freedom to implement their intended goals and plans. Compliance with the ISO 9001 is appropriate for companies where clear and consistent control principles are promoted. If new fields are affected, it is fraught with the loss of the status of an enterprise with corresponding certification and a significant change in the mode of business activities.

Cultural Barriers

ISO 9001 is meant to be an international standard, but it is often out of reach for businesses in less developed countries. For example, African nations account for only 1% of ISO certifications worldwide (Tene, Yuriev & Boiral 2018). There are tremendous barriers to adoption which further marginalizes businesses in underdeveloped countries. Partially, this is due to poor institutional frameworks, lack of human and financial resources, and low participation.

However, the unique aspects of local culture and traditional values reflect on management culture and styles in these regions, affecting hierarchy, tolerance, business dealings, and collectivism (Tene, Yuriev & Boiral 2018). Inherently, specific traditions may be present all over the world, but ISO management standards do not account for this and force businesses to drastically change and abandon their unique cultures.


In general, the analysis and evaluation of literature devoted to the ISO 9001 standard show that some of the claims related to its sophisticated character might be justified. However, in the majority of cases, situations of this sort emerge because of the poor adaptation of the basic assumptions of the model to the existing demands of the company. Based on the data and examples studied, the implementation of relevant standards is optimal in those enterprises where clear and stable control systems are promoted. In this case, if creativity is an essential part of the workflow, there is the likelihood of stagnation. In this regard, the size of organizations plays a significant role. The introduction of standardization contributes to the improvement of product quality, but in small companies, this principle of control may be unjustified.

The standard in question may be beneficial in creating discipline and obedient employees. However, they will likely cause demotivation amongst the workforce stuck in the same routines and lead to a lack of creative ideas and solutions necessary for the growth of the business (Manders, de Vries & Blind 2016).

It is particularly relevant for SMEs which depend on critical thought and innovation to compete with larger corporations, with many of them focused on creative projects instead of large manufacturing (Khan & Farooquie 2016). Therefore, it is essential to create those working conditions that could satisfy different stakeholders in order not to affect the outcomes of business activities negatively and not to complicate the whole production process. Nevertheless, in the case of proper introduction, the ISO 9001 standards may be of good use as a valuable instrument for building a strong and productive team with high motivation and performance results.

Alternatively, if applied correctly, the given framework is a potent tool for the improvement of almost all aspects associated with the organizations’ work as it provides guidelines on how to achieve the highest effectiveness and quality of products by observing basic rules. For this reason, the paper proves the high effectiveness and relevance of the ISO 9001 regarding the functioning of modern companies and the existing business environment.

Discussion and Recommendations

Quality management is the aspect of management science that has extensive research on various aspects and theories which should effectively translate to practice. Models such as the ISO-9001 standards were developed to eliminate confusion among low-level managers that did not have a clear understanding of total quality management and its implementation within an organization. The standards create a structured system that can be used by executives to provide explanations and actionable directions to employees and lower managers. The internal effects of ISO-9001 implementation are noticed through a strongly developed system of procedures and clearly defined responsibilities that identify the organizational structure and reduces improvisation or operational discrepancies (Al-Ibrahim 2014).

When implementing ISO 9001, many organizations lose opportunities for improvement, largely because they attempt to standardize their operations rather than practicing the standards. Research evidence suggests that the motives, costs, and process of achieving the certification, with all its benefits and challenges, do not significantly differ amongst organizations, no matter the size or industry. However, motivations for ISO system implementations differ from their benefits. While the motivations are based on marketing and sales, the inherent outcomes are meant to be focused on management and operational efficiency (Ingason 2015).

Therefore, the subsequent success of ISO 9001 QMS should be considered in the context of a company’s approach. It is vital to understand influential factors to quality practices. When the company motivations are to obtain certification depends on external pressures such as consumers and competitors, with ISO 9001 becoming a marketing tool, it will be inherently unsuccessful. In such cases, there is conformity at the administrative level but lacking the optimization of QMS effectiveness (Psomas & Antony 2015).

The complexity and bureaucracy of the ISO 9001 implementation can be mitigated by applying an internal process management approach. Considering the motivational factors for success, it may be viable to conduct training and education sessions before beginning the process. It is important that all employees, particularly those resistant to change participate in the change management program. With consistent training, a quality culture within a company can be inherently transformed to ensure both comfort and willingness to accept change and focus on QM implementation (Sfakianaki & Kakouris 2018).

Another recommendation commonly voiced by organizations is the need for government and legislative oversight to the certification process. This includes a framework that helps guide enterprises from application to the final certification. Also, a mechanism that would conduct audits post-certification to ensure compliance in both process and product (Zeng, Tian & Tam 2007). These methods could have a profound impact on helping smaller enterprises that face certification challenges. Furthermore, close guidance and oversight during the certification process could better ensure that the certification is competently achieved, with essential process change rather than a superficial approach that some companies may take.


Information acquired during the research evidence the high effectiveness of the ISO 9001 standard if applied appropriately. For this reason, there are multiple opportunities for the implications of the given framework and its use in modern companies to achieve better results. First, the approach can be utilized to manage knowledge among workers and increase their levels to ensure a high level of competence and better performance (Ochieng, Muturi & Njihia 2015).

Literature proves the fact that ISO contributes to a better quality of products and services which can be achieved by the enhanced employees’ functioning. Second, the framework can be used to align better resources management by minimizing input and maximizing output which is critical regarding the existing level of rivalry and necessity to generate competitive advantage (Ingason 2015). Third, adherence to the standard can help to improve leadership practices peculiar to various companies, and provide leaders with more effective tools and approaches to work with employees, organize and motivate them to achieve better results.

Regarding the use of the standard at the enterprises of various sizes, which is among the basic aspects of this study, it has been experimentally proved that utilizing the ISO 9001 documentation has distinctive implications. According to Wilson and Campbell (2018), in those organizations where the stable principle of strategic leadership is maintained, appropriate certification improves the quality of control over production efficiency.

However, in small and start-up companies with a growing financial base, such standards are unlikely to be successful. The analysis of the aforementioned academic literature and the properties of this document confirms that in the conditions of limited production and reserved monitoring policies, the application of the ISO 9001 standard may do more harm than good. The heads of individual structural units will be forced to adhere to the well-established rules of interaction with the staff and resource allocation, which, in turn, will not allow a particular enterprise to develop freely and build capacity. Moreover, a longer time to enter the market will be required, which will slow down making profits. Accordingly, the implications will vary depending on the size of companies and their production potent.

Finally, the standard can be used by the majority of modern companies to evaluate their performance and reveal critical flaws that can result in the deterioration of outcomes and decreased profitability (Khan & Farooquie 2016). The given list of implications evidences the advantageous character of the ISO 9001 standard and provides managers with the potent tool for the improvement of their work and achievement of better results with the help of the major assumptions and practices outlined by the ISO 9001.


ISO 9001 is a vital standard in quality management that should be sought by all organizations in a variety of sectors. However, the motivations behind it should focus on inherent change rather than superficial purposes to achieve certification. ISO 9001 has been proven to have a profound change in the organizational process and quality of products if implemented correctly. The standards are not perfect and create challenges in some contexts based on the type, size, and location of an organization. However, these barriers can be mitigated, and ISO standards receive crucial updates every few years. Overall, the common criticism of ISO 9001 is largely unjustified and presents an example of poor management rather than the fundamental change in QM that the certification is meant to achieve.

Reference List

Al-Ibrahim, A 2014, ‘Quality management and its role in improving service quality in public sector’, Journal of Business and Management Sciences, vol. 2, no. 6, pp. 123-147. Web.

Anttila, J & Jussila, K 2017, ‘ISO 9001:2015 – a questionable reform. What should the implementing organisations understand and do?’, Total Quality Management & Business Excellence, vol. 28, no. 9-10, pp. 1090-1105.

British Standard Institution 2019, ISO 9001 quality management. Web.

Heras-Saizarbitoria, I & Boiral, O 2019, ‘Faking ISO 9001 in China: an exploratory study’, Business Horizons, vol. 61, no. 1, pp. 55-64. Web.

Ingason, HT 2015, ‘Best project management practices in the implementation of an ISO 9001 quality management system’, Procedia – Social and Behavioral Sciences, vol. 194, pp. 192-200. Web.

International Organization for Standardization 2015, Quality management principles. Web.

International Organization for Standardization n.d., ISO 9000 family – quality management. Web.

Khan, A & Farooquie, JA 2016, ‘Motives and benefits of ISO 9001 quality management system: an empirical study of Indian SMEs’, Brazilian Journal of Operations & Production Management, vol. 13, no. 3, pp. 320-329. Web.

Lushi, I, Mane, A, Kapaj, I & Keco, R 2016, ‘A literature review on ISO 9001 standards’, European Journal of Business, Economics and Accountancy, vol. 4, no. 2, pp. 81-85. Web.

Manders, B, de Vries, HJ & Blind, K 2016, ‘ISO 9001 and product innovation: a literatute review and research framework’, Technovation, vol. 48-49, pp. 41-55.

Ochieng, J, Muturi, D & Njihia, SN 2015, ‘The impact of ISO 9001 implementation on organizational performance in Kenya’, The TQM Journal, vol. 27, no. 6, pp. 761-771. Web.

Psomas, E & Antony, J 2015, ‘The effectiveness of the ISO 9001 quality management system and its influential critical factors in Greek manufacturing companies’, International Journal of Production Research, vol. 53, no. 7, pp. 2089-2099. Web.

Psomas, E & Pantouvakis, A 2015, ‘ISO 9001 overall performance dimensions: an exploratory study’, The TQM Journal, vol. 27, no. 5, pp. 519-531. Web.

Sfakianaki, E & Kakouris, AP 2018, ‘Obstacles to ISO 9001 certification in SMEs’, Total Quality Management & Business Excellence, pp. 1-21.

Tene, CV, Yuriev, A & Boiral, O 2018, ‘Adopting ISO management standards in Africa: barriers and cultural challenges’, in I Heras-Saizarbitoria (ed), ISO 9001, ISO 14001, and new management standards. Measuring operations performance, Springer, Cham, Switzerland, pp. 59-82.

Wilson, J. P & Campbell, L 2018, ‘ISO 9001:2015: the evolution and convergence of quality management and knowledge management for competitive advantage’, Total Quality Management & Business Excellence, pp. 1-16.

Zeng, SX, Tian, P & Tam, CM 2007, ‘Overcoming barriers to sustainable implementation of the ISO 9001 system’ Managerial Auditing Journal, vol. 22, no. 3, pp. 244-254. Web.

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