Iso, international standards for quality management and assurance, was developed by?

The authors of this study, who adopted a holistic view of the international organization for standardization (ISO) 9000 series of standards, aimed to evaluate the current status of the standards within the framework of the quality movement. Specifically, the evaluation covered two dimensions, i.e. the significance of the content included in the standards and the quality of the standards’ elaboration, which encompasses such issues as, for instance, their correctness, relevance to current trends in quality management, comprehensibility, etc.

The paper is based on a review of the scientific literature, analysis of the current and all previous versions of the international standards and the results of a survey, through which data were collected from 73 quality management experts from 17 different countries. To evaluate the results, an importance-performance analysis was performed.

As the results of the research demonstrated, experts in quality management have accepted the ISO 9000 standards series. However, this positive view refers mainly to the very idea of developing quality management standards and these standard’s content structure (components included in them). Study participants assigned a low rating to the quality of the standards’ elaboration. Therefore, improving the following aspects of the standards is essential: definitions, guidelines explaining the requirements for a quality management system, self-assessment tools and guidelines concerning quality management concerning chosen forms of activity.

The research described here in has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management but can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components which they will find are the most useful.

The research described herein has both practical and social implications. First, it delineates the direction needed to improve standardizations, whose use need not be strictly limited to quality management. However, it can be successfully used to improve the standards in other areas of management. Therefore, the conclusions of this research directly contribute to increasing both the effectiveness and the quality of the standard organizations. The significant consequences of this research for managers are the identification of ISO 9000 components, which they will find are the most useful.

Most research treats ISO 9000 standards as a benchmark for their studies on quality management systems implemented in organizations. The standards themselves are rarely the subject of a study, and so this paper fills a gap in the research and provides insights into desired directions for standards improvement.

1. Introduction

In 1997, Seddon was highly critical of international quality management standards. Among other standards, he asserted that “ISO 9000 has only succeeded in steering quality into troubled waters. Far from being the first step to quality, it has been a step in the wrong direction” (Seddon, 1997).

A total of 23 years have elapsed, as that moment and much has changed. The standards have undergone several revisions, the number of ISO 9001 certified organizations has increased to nearly five times its size during Seddon’s time (www.iso.org) and new standards concerning quality management and other subjects (e.g. occupational health and safety, energy and human resources) have been instituted. Moreover, numerous scientific studies have been conducted on ISO 9000 series of standards and the focus of researchers has been issues related to procedures for the successful implementation of a quality management system and the benefits of this implementation. This limitation is unjustified, primarily because it omits or depreciates the significance of ISO 9000 series standards other than those dedicated to quality management, a situation John West describes as follows:

I have observed that awareness of the existence of these and other guidance documents by users seems to be declining. While my data is certainly anecdotal, I find that most new users and even a number of »ISO consultants« I have met are unaware of their existence. And the lack of awareness extends to supporting standards, not just free guidance. And there is plenty of other free guidance available as well! There is a great deal of richness in the ISO 9000 family of documents and it is a shame for users not to know about and take advantage of the full range of possibilities (West, 2007).

What West describes is indeed happening, even though the International Organization for Standardization, in its publications and through its representatives, clearly states that the entire body of standards should be instituted all together and at the same time. Cary Cort (Chair of ISO/TC 176) claimed the following:

I believe we must look beyond individual standards and acknowledge the pre-eminence of a dynamic web of interconnected, mutually supporting standards, guidelines and associated collateral that collectively enable and sustain the ISO 9000 family of standards. I call this interdependent network the ISO 9000 ecosystem, and its primary focus is to create a compelling value proposition for the front-line users and potential users of the ISO 9000 family of standards (Cort, 2010).

On the other hand, it should be remembered that some researchers question the quality and usefulness of international standards. For example, Spring (2016), stated as follows:

Many would like to believe that standards are managed in a coherent and logical way. Indeed, some management and coordination efforts (…) have met with success. Many other standards arise […] as the result of needs that are far less planned.

Based on the above-stated information, the following problems can be identified:

• What is the current status of the ISO 9000 family of standards (regarded as a whole) in the quality management movement framework?

• Are these standards widely accepted and recognized among specialists dealing with quality management?

• Are these standards viewed as a valued and important part of the quality management concept? Do they reflect modern trends in management?

• Do these standards constitute a consistent and useful approach?

To attempt to answer these questions, this research sought to evaluate the quality of the ISO 9000 family of standards, and evaluation that covers two dimensions. The first is the significance of the content included in certain standards. Specifically, this research sought to determine whether separate components of the standards (i.e. those distinguishable on the basis of their content) are significant enough to be included in the standards even if not properly elaborated. The second dimension is the standards’ elaboration quality, which takes into consideration such issues as, e.g. their correctness, relevance to current trends in quality management and comprehensibility. To gather this information, we administered a carefully prepared questionnaire to experts in quality management and in ISO 9000. This questionnaire was designed specifically to gather the expert opinions of the respondents, whose recruitment is described below, to answer the following research questions:

RQ1.

Is the ISO 9000 family of standards a generally accepted part of the quality movement?

RQ2.

Which components of the ISO 9000 family are viewed as the most significant?

RQ3.

Which components of the ISO 9000 family are viewed as being elaborated best?

RQ4.

Which components of the ISO 9000 family should be improved first?

The search for answers to these questions is justified by the literature. According to Hoel and Chen (2018), there is a need to maintain feedback loops between standardization and scientific research. Standards-making (and improving) should be based on research results, but on the other hand, standards should be the subject of scientific evaluation.

Different methodologies were used to carry out the research needed to answer these questions: a review of the relevant literature, analysis of the current and all previous versions of the ISO 9000 series of standards, a survey (i.e. computer-assisted web interviews – CAWI) and an importance-performance analysis (IPA).

The structure of this paper is as follows: Section 2 reviews the relevant literature to present the background of the study and Section 3 describes the methods used to carry out the study, including defining the data-collection instrument, sampling and conducting the IPA technique. Section 4 identifies the most relevant results of the survey. Finally, Sections 5 and 6 present the discussion, recommendations for future research and implications of the study.

2. Literature review

Scholars have studied the quality management system based on ISO 9001, as the publication of its first version in 1987. As then, hundreds of studies have been conducted to examine the effects of the standard’s application on enterprises, banks, public administration offices and other organizational types. Moreover, systematic literature reviews that investigated the most critical problems related to the ISO 9000 series of standards have been collected and analyzed. For example, Sampaio et al. (2009) analyzed over 100 articles, finding that the primary issues addressed were the following: evolution of the certification market; the benefits, barriers and drawbacks associated with implementation; the impact of implementation on organizations; and the organizations’ financial performance following implementation.

Although some authors proposed additional topics deserving more in-depth analysis, none of these evaluated the standard itself. For instance, Tarí et al. (2012) studied 82 papers on ISO 9001, identifying the 13 most common benefits of instituting the standards that were analyzed by scholars, including improvements in market share, sales, profitability, image, efficiency and customer satisfaction. According to the research results, the scope of these benefits decreased as the number of certified enterprises increased (thereby decreasing the effects of competitive advantage). The studies conducted by Casadesus, Karapetrovic, et al. clearly exhibit this pattern; the range of benefits obtained by the large sample of enterprises the authors analyzed decreased in the years 1998–2006 (Casadesus and Gimenez, 2000; Casadesus and Karapetrovic, 2005; Karapetrovic et al., 2010).

Another relevant field of study has been the organizational effectiveness of management systems based on the ISO 9001 standard. Boiral (2012) reviewed 111 papers on internal benefits, including those impacting effectiveness and efficiency. The author found that multiple benefits could be linked not to ISO 9001 but rather to other phenomena occurring simultaneously. Based on a systematic review, the author presented 46 variables related to both organizational effectiveness and ISO 9001 requirements.

Addressing the controversy surrounding the impact of ISO 9001 standards on product innovation, Manders et al. (2016) reviewed 29 studies, concluding that multiple factors, including sector, region, company size and impact innovation, were responsible for organizations’ health, making the impact of ISO 9001 adherence unclear. As the results of the systematic literature reviews discussed above show, unambiguously positive effects of ISO 9001 implementation become increasingly difficult to identify with the passage of time. Saraiva et al. (2017) studied research papers concerning motivations, benefits and difficulties associated with the implementation and certification of quality management systems based on ISO 9001 requirements. They also found that type of benefits, and the degree to which they are exhibited, to be subject to multiple factors. Moreover, Serhan and Kabèche (2017) drew attention to the so-called “ISO 9001 Paradox,” which attempts to combine conformity and innovation. Kafel and Nowicki (2014) reported a high cost of ISO 9001 quality management certification causing organizations to withdraw from these certifications.

As the analysis of systematic literature reviews shows, most authors treat ISO 9001 standards as a starting point for their research. They assume that the standard is a model to which an organization’s functions should be adjusted. ISO 9001 is treated as a kind of framework for achieving a variety of strategically essential results, namely, profit growth, income growth, customer loyalty and organization image (Urban, 2012). Although this assumption is not explicitly formulated in most of those studies, it is nonetheless assumed and has important implications. The limits of the standards are often discussed in scientific conferences in the field of quality management. Meanwhile, only a few researchers have assessed the ISO 9001 itself. The versions of the standard published in 1987 and 1994 were subject to more criticism (Seddon, 2000; Hallström, 2004) and the 2000 version represented a significant step forward that eliminated most of the weaknesses present in previous versions. However, in a constantly changing business environment, standards should be updated regularly to best suit organizational needs and 2000, 2008 and 2015 versions served this purpose.

However, the question often arises as to whether changes introduced in these versions were sufficient. Gotzamani’s (2010) investigation into the effects organizations experience when they update their quality management systems to be consistent with ISO 9001:2000 requirements revealed that the 2000 revision achieved most of its goals, including those related to leadership, process management, customer focus and continuous improvement. Gutiérrez et al. (2010) used a different approach, comparing the results achieved by companies resulting from the implementation of ISO 9001, the EFQM model and Six Sigma. Based on the quantitative analysis of 234 organizations, they found that the EFQM model requires increased teamwork, whereas Six Sigma requires increases in support by top management, in process management and in statistical process control compared to ISO 9001. Thus, these authors indicated possible directions for improving the standard. Fonseca and Domingues (2017) asked experienced auditors to evaluate the assumption that ISO 9001:2015 is in line with modern business and quality management concepts and statistical analysis of surveys returned by 393 auditors confirmed that assumption. Unfortunately, the paper did not include a detailed analysis of ISO 9001:2015 requirements. Analyzing how changes in the 2015 release impacted enterprises that implemented or updated their quality management systems, Anttila and Jussila (2017) pointed out that the pace of change in the standards is significantly slower than those in a typical business environment and in society in general, a conclusion that contradicted previously presented research results.

It should be noted that the research methodology, scientific rigor and attitude of researchers have an impact on their research results. In particular, rationalization of actions undertaken by enterprises and the business interests of auditors may render results too optimistic. Therefore, research concerning ISO standards should be carried out using a methodology capable of providing objective results.

3. Methodology

This study used a quantitative methodology and used sample surveys, a basic research method commonly used in the social sciences and an important tool in applied work (Wright and Marden, 2010), to gather the necessary information from the study’s respondents. The survey was administered to these respondents through CAWI and IPA was used to analyze the collected information.

4. Results

The average of all grades concerning the significance of separate components was 4.07, indicating, in general, that the expert respondents believed that the ISO 9000 series standards are appropriately constructed, as all the elements they include are important. However, opinions diverged with respect to separate issues. “Requirements for a system of quality management,” “quality management principles” and “definitions” were ranked highest, whereas “information on the standards prepared by the committee ISO/TC 176 Managing quality and maintaining quality” was ranked least important (Table 6).

The average of all grades concerning the quality of specific components was 3.63, indicating that the experts evaluated the ISO 9000 series standards to have been properly written, in general. Still, opinions as to the quality level of specific components diverged. The highest rankings were given to “quality management principles,” “requirements for quality management systems,” and graphic presentations of the relations between terms and definitions, whereas “the guidelines concerning quality management in specific situations” were awarded the lowest grades (Table 7).

The IPA was used to evaluate all components simultaneously in reference to both criteria used in the research (Figure 2).

Based on the results shown in Figure 2, the components included in ISO 9000, ISO 9001 and ISO 9004 were divided into six groups (Table 8).

5. Discussion

The first research question (RQ1) asked whether the ISO 9000 family of standards was a generally accepted part of the quality management concept. Study findings indicated that they are widely accepted, thereby confirming the positive opinions concerning the standards that have appeared in the scientific literature (Fonseca and Domingues, 2017; Gaspar et al., 2018). Study results also indicated differing assessments of the two dimensions. Rated higher was the significance of the components included in the standards and the scores related to the significance of the separate components was 4.07, indicating that the experts assessed the ISO 9000 family of standards as including significant elements.

However, the respondents’ assessment of the quality of the standards’ elaboration (i.e. their correctness, relevance to current trends in quality management, comprehensibility, etc.) was not as certain. The average score here was 3.63, indicating that, although the quality of the standards was judged acceptable (i.e. it was greater than 3), it was not evaluated high, i.e. four or greater. Therefore, the experts can be assumed to, in general, accept the standards of ISO 9000 series but rate as low or merely average their usefulness in clarifying the essence of quality management, creating a terminology order, providing a competitive advantage, etc.

This finding is in accordance with the results of research carried out by Gutiérrez et al. (2010), who dealt primarily with the ISO 9001 standard. The authors showed that, on the basis of the ISO 9000 family, an organization can make the initial step only in fully implementing quality management. However, the expectations of the experts who participated in the current study might have been too high. Also, worth noting are the nature of the standards, the goals of standardization (i.e. to publish specifications for common and repeated use, aimed at achieving an optimum degree of order or uniformity in a given context, discipline or field) and, finally, the rules of standards development elaboration (e.g. development of standards through a multi-stakeholder process and on the basis of a consensus). Under these assumptions, ISO 9000 standards cannot be expected to include highly innovative or unique solutions fully adjusted to every organization’s needs. What may be expected from them is to be appropriately elaborated on the basis of current knowledge.

The second research question (RQ2) was formulated as follows: Which components of the ISO 9000 family of standards are the most significant? The research allowed the identification of the five most significant components of the ISO 9000 family of standards. The first place in the chart was given, not surprisingly, to “the requirements for the quality management system.” The next places in the chart were as follows:

• Quality management principles;

• Definitions;

• Guidelines explaining (interpreting, exemplifying, etc.) the requirements for a quality management system; and

• Self-assessment tool.

The opinions on the significance of the last two components above were much more diverse than those related to the previous three components (as shown by the higher standard deviation values). The scores given to the five components above (which were higher than 4 in every case) indicate that, in the expert opinions, they constitute the core of the ISO 9000 family of standards. Thus, it seems reasonable to assume that experts in quality management recommend that the components be used to design or review standards concerning other fields (e.g. energy management or human resources).

The third research question (RQ3) was designed to establish which components of the ISO 9000 family of standards are elaborated best. Generally speaking, the quality of the ISO 9000 family of standards elaboration was not evaluated high. The experts who participated in the research assessed “quality management principles” as having the highest level of elaboration (average score 4.27). Given that they were ranked as the second most significant component, it can be claimed that they are the strength of the ISO 9000 family of standards. The next most highly ranked component with respect to quality was “the requirements for quality management systems” with an average score of 4.04, meaning that the experts accepted the way in which it expressed requirements. However, in their assessments, they pointed out that they see the quality management system as a “mediocre” solution at best.

The next places in the chart were as follows:

• Graphic representation of relations between terms and definitions;

• Description of the relation between chosen standards;

• Definitions; and

• Self-assessment tool.

They were all evaluated with scores of less than 4, indicating that, although their level was judged acceptable, they received low or very low recognition among the experts.

The last research question (RQ4) was: Which components of the ISO 9000 family of standards should be improved first? The IPA helped identify these components, which were characterized by both relatively high significance and low elaboration quality. This group included the following four factors:

1. Definitions;

2. Guidelines explaining the requirements for a quality management system;

3. Self-assessment tool; and

4. Guidelines concerning quality management in relation to chosen forms of activity.

An apparent contradiction is noticeable in the case of two components, i.e. “definitions” and “self-assessment tool.” Both were included in the best-elaborated factors and also in those which should be improved first. This situation has a logical explanation. Although the quality of elaboration of the two components is higher than the rest, it is still noticeably lower than the quality of elaboration of the quality management principles. The scientific literature provides some signals that serve to confirm this interpretation. Among others, Anttila and Jussila (2017) note the general ambiguity of many fundamental concepts and definitions included in the standards. The low quality of definitions was also pointed out by Olsen and Borit (2013). On the other hand, Bendell (2000) focused attention on problems related to the self-assessment tool.

6. Conclusions

The ISO 9000 family of standards has existed for over 30 years. During this time, it has become a part of the quality movement and has been identified as one of the most important international standards. The research reported herein demonstrated that it has gained the acceptance of experts dealing with quality management. However, this positive view refers primarily to the general idea of developing quality management standards and the content structure of the standards (i.e. the components included in them). The quality of the standards’ elaboration was rated noticeably lower. Therefore, it is essential to improve four aspects of the standards, i.e. definitions, guidelines explaining the requirements for a quality management system, the self-assessment tool and guidelines concerning quality management in relation to chosen forms of activity. It might also be reasonable to consider removing those components from the standards whose significance was ranked lowest.

Future research should be oriented primarily on directions and possible ways of improving the four components. So far, little attention has been paid to them. Therefore, it is crucial to establish the weaknesses of each component, the expectations of the users of the standards concerning these components and the opportunities that exist to meet those expectations. It should also be noted that choosing another version of the IPA technique (e.g. “IPA oriented to balance”) could lead to slightly different conclusions of the study because it puts more emphasis on the difference in the assessment of importance and performance. Therefore, it would be worth carrying out such research and comparing the results.

The research reported here has both practical and societal implications. It points the way to improve the standards, the applicability of which is not strictly limited to quality management, which may be successfully used to improve the standards in other management areas. The research conclusions can be directly used to increase the effectiveness of standardization organizations and improve the standards’ overall quality. A significant implication for managers is identifying and pointing out the components of the ISO 9000 family of standards (other than requirements for a quality management system) that may become interesting and useful to them in managing their organizations.