The quality of products or services is a reflection of company’s ability to improve by process management [1]. The accomplishment of a quality product or service is the reason why quality management systems (QMS) have been created or improved to assure this characteristic, and at the same time, achieve customer satisfaction. The usage of a QMS is fundamental to support an organization’s performance, providing a range of benefits for improvement; thus, it has a positive effect on organizations [2]. The literature shows many QMSs that are related to attainment of quality in products or services, such as Total Quality Management (TQM), the Malcolm Baldrige National Quality Award (MBNQA), European Foundation for Quality Management (EFQM), Six Sigma (SS), Lean Manufacturing (LM) and the ISO 9001 standard, among others. The main focus of this research is the international ISO 9001 standard, created by the International Organization for Standardization (ISO). The most recent version of the standard is the ISO 9001:2015, which focuses on the adequate management of activities in order to accomplish and exceed customer requirements [3].

The ISO 9001 standard is by far the most implemented and recognized QMS and helps companies to achieve continuous improvements; hence, the standard allows for the guidelines to improve the operational systems of the company. According to the requirement manual of the ISO 9001:2015, the standard is a set of almost 20 complementary standards that provide the theoretical and practical support in almost all the functional areas of an organization for the accomplishment of regulatory requirements and customer requirements.

In this respect, the objective of this paper is to recognize the current situation of the ISO 9001 standard and its critical factors, which allows for the implementation of the standard in the manufacturing sector in Mexico (MSM). To achieve this objective, a survey was first designed to collect data, and secondly, a statistical analysis was carried out to describe the current situation of the standard in Mexico.

Some obstacles prevent the development of the standard. Santos et al., [28] described how these barriers can be associated with a lack of focus on the critical factors for an adequate implementation. The literature classifies the most common barriers in two ways: the barriers related to leadership and those related to the engagement of people. Destitute leadership carries problems such as: misunderstanding ISO 9001 standard requirements, lack of communication between the business areas, financial issues, lack of strategic thinking, poor auditing systems, stationary issues and lack of a continuous improvement focus [29-31]. Barriers related to the engagement of people creates problems such as: lack of cooperation and involvement of people, lack of discipline following new work methods, resistance to change, insufficient training and lack of motivation to improve [32,33]. Another barrier reported is the large time needed for implementation, since some business do not have time to develop this kind of project or the business resources are limited to a very short amount of time [33,34]. Additionally, [31] mentions that the paper work bureaucracy within the business and procedures could stop the fluency of information and decision-making in some cases.

In the context of benefits, the literature consulted reports that these can be acquired by implementing the ISO 9001 standard in all types of businesses or industries. For example, [35] reported a decrease in manufacturing times and the redesign of pieces to reduce waste, which means an increased improvement to the business’ quality system. Moreover, some authors describe how the quality management achieved by the ISO 9001 standard addresses the business to work with TQM [13,20,25]. Some benefits of the ISO 9001 standard are related to the improvement in the manufacturing systems, which leads to the production of quality products, as well as the productivity of the business increasing [33,36,37]. Additionally, [38] described how the ISO 9001 standard improves the speed of services and reduces customer complaints related to banking services. In addition, [39] describes how the SMEs food enterprises can achieve some benefits by implementing the ISO 9001 standard, such as continuous improvement, prevention of nonconformities and customer satisfaction focus. Some authors [30,40,41], agree that a business acquires wide competitive characteristics, which means that the effectiveness of its systems increase the profits, and described how the benefits are related to the effective implementation of the standard; in other words, the organization must maintain the benefits acquired by the standard as long as the organization develops and practices a continuous improvement that focus on increasing profit and productivity. Likewise, [33,37,42] described that, when the industries increase productivity, customer complaints tend to minimize, and as a result, customer satisfaction is improved. Customer satisfaction is synonymous to better customer service, which means the business is accomplishing as many requirements, asked for by the customer, as possible. Additionally, the business involves the customer feedback to improve its systems and services; performance in customer satisfaction may strengthen business relationships that encompass and reach new market shares and marketing tools [12,43]. Another study by [44] describes 20 benefits that are acquired by SMEs in Soudi Arabia, such as: (1) increased quality awareness, (2) efficiency improved in the quality system and quality products, and (3) improved customer service, to mention a few. Dowlatshahi [45] defines how the ISO certified companies placed more emphasis on the relationship with main suppliers in a management supply chain system, obtaining more competitive advantages than those that were not certified, which tended to place more emphasis on price and delivery issues.

The literature reported a variety benefits that were developed by the implementation of the ISO 9001 standard, as well as many barriers that preclude its implementation; however, no literature on these topics was found in the MSM, which represents a lack of information in this context. Hence, this research will analyze the data acquired related to barriers and benefits perspectives, in order to acknowledge the current situation in the MSM.

Recently, the ISO survey of Management System Standard Certification [46] reported more than 400,000 organizations certified with ISO 9001:2015 worldwide, of which 2,577 were in Mexico. In accordance with this information, Table 1 represents the subsector classification certified with the ISO 9001:2015 standard in Mexico.

Table 1

Source: ISO Survey 2018.

The MSM is the second greatest contributor to the Gross Domestic Product (GDP) after the primary activities sector, and has the lowest annual rate of variation of all economical sector in the country, as reported by the National Institute of Statistics and Geography (INEGI, for its acronym in Spanish) [47]. According to the National Statistical Directory of Economic Units (DENUE, for its acronym in Spanish) [48], nearly 36,000 manufacturing industries exist and are classified as SMEs and large companies. It is worth mentioning that, in this paper, the SME classification is the one used in Mexico. Finally, data from the Economic Ministry [49] mentioned that until 2012, 1,442 manufacturing industries, certified in ISO 9001:2008 in Mexico, existed, but unfortunately, this database is not currently operational. Additionally, [46] shows the number organizations with ISO 9001 standard from 2010 to 2017 in North America (United States, Canada and Mexico), as shown in Fig. 1. In the first period of time from 2010 to 2013, an increase in the number of certified organizations can be seen in three countries where, in 2013, the highest number of certified organizations was in the United States and Canada. In the second period of time from 2014 to 2017, Mexico had a remarkable increase, with a tendency to keep growing, while in the United States and Canada, a decrease in the number certified organizations can be observed, where 2017 registered the lowest number of organizations certified.

Figure 1 Source: ISO Survey 2018.

This resembles the results of [50], which identifies a perspective for certification growth of most countries, with the exception of the United States and Canada mainly after the revision of the standard in the year 2000.

The ISO/TC 176 Technical Committee (TC) on quality management and quality assurance has been a leader in the development of standards in the field of QMS since 1979. The TC 176 develops standards through its three subcommittees (SC), which are responsible for the development and maintenance of the ISO 9001 standard, as well as all adjacent standards within the ISO 9000 series [51]. In Mexico, the management of the standard comes directly from the General Direction of Standardization (DGN, for its acronym in Spanish), which is an internal institution of the Economic Ministry responsible for arranging the Mexican Norms (NOM) in order to coordinate the standardization and conformity assessment systems to promote the competitiveness of the industry and commerce in a national and international approach. The DGN, with The Mexican Institute of Standardization and Certification (IMNC, for its acronym in Spanish), created the NOM series NMX-CC-9001-IMNC-2015, which is in accordance with the ISO 9001:2015 standard in every guideline established by the ISO.

The Mexican Accreditation Body (EMA, for its acronym in Spanish) is a private institution that is responsible for the accreditation of the Conformity Assessment Bodies to evaluate and certify the business once it accomplishes the requirements of the ISO 9001 standard. Fig. 2 shows a representative diagram of the standard management in Mexico.

Figure 2 Source: The Authors.

The target population for the study consisted of the manufacturing industries in Mexico that have or have had the ISO 9001 standard certification, preferably in the 2008 or 2015 version, within the SMEs and large company classification. The study relayed the survey made for this research, based on the literature, with 55 items in a five-point Likert scale (1: never, 2: rarely, 3: regularly, 4: almost always, 5: always) that was related to the level of use of each QMP. This survey was divided in four main sections: the first section with 10 items for demographic data; the second corresponded to the items for the QMPs (7 items for LD, 4 items for CF, 6 items for EP and PA and 5 items for IMP, EDM and RM); the third section had 7 items related to benefits; and the last section had 7 items that were associated with barriers. The survey was mainly focused on quality or manufacturing managers; however, any personnel with a position of middle management, related to the QMS of the organization, could respond. Likewise, the sample size was calculated using eq. (1), which considered a finite population. To do this, a population (N) of 37,148 SMEs and large companies, established in Mexico at the time of the study, was used according to [46]. Additionally, a 99% confidence level (Z _α ) and a 50% sample proportion (p), and therefore, an equivalent value for q were considered. Finally, a 10% error margin (i) was used to obtain a sample size (n) of 166 responses. The survey was shared by e-mail and the social network LinkedIn, obtaining 537 responses; however, a total of 172 complete responses were used in the study to accomplish the required data for significant results at this level of confidence.

In the context of industry size, some similar results were reported in [8,52,53], describing size as an influencing factor in the decision to achieve the ISO 9001 standard, even for [54] the size of a company, which certainly influences the implementation of the QMS, where large companies obtain better results with greater tolerance to changes from the introduction and the subsequent maintenance of the QMS. Additionally, Stainslaus et al., [55] described how the SMEs should learn from the QMS used by large companies.

According to the CSF, the results reported in the literature resembles those obtained in this study. For example, [8,55,56] described top management leadership as one of the main characteristics to arrange a QMS into the organization procedures developing goals and objectives. Further, [57] described how top management leadership and the engagement of people provides for the implementation of the standard. In the same matter, [58] showed that the customer focus, human resources management and the strategic planning of the quality should have the highest consideration when implementing the standard. Finally, [59] revealed that the industries certified in the ISO 9001 standard have an excellent relationship management, and, the organization with engaged personnel also, significantly facilitates the accomplishment of the standard guidelines.

Similar results in the context of barriers were obtained by [60], which described the standard as a beneficial tool for the industry, but at the same time, turns to bureaucratic and complex procedures, which demotivates top management to start the implementation of the standard. Additionally, [61] mentioned that the bureaucracy of the standard in the process, the lack of interest of the management, the high investment and the long time required for its implementation are some of the obstacles and limitations in application. Furthermore, [62] mentioned how the lack of commitment by top management and the financial or resource limitations preclude the assessment of the standard. According to the results, the high investment required and the bureaucracy style of the standard are barriers to implement the standard in the MSM, which resembles the one reported in the literature; however, the lack of demand of the ISO 9001 certification by customers is not reported in the literature as a barrier, while in Mexico, according to the data obtained, this is the main barrier of manufacturing companies not implementing the standard.

The results related to the benefits agree with the findings in the literature, for example, [33,36,39,42], which described how the implementation of the standard increases customer satisfaction and productivity of the company. Likewise, [35,37,44] reported that, when implementing the standard, the integration of the continuous improvement in the company is developed, increasing productivity into the work systems and errors and waste are reduced, thus increasing the benefits. Finally, [63] described the adaptation of the standard to improve the efficiency of operations and marketing strategies, increasing the commitment of people with the accomplishment quality and transforming the organization to work as a synchronized system in order to fulfill the enterprise’s goals.

As was previously mentioned, the objective of this research is to recognize the current situation of the ISO 9001 standard in organizations in the manufacturing sector in Mexico taking SMEs and large companies as a reference. This research was focused on describing the critical success factors, as well as the benefits and barriers, which are associated with the implementation of this standard in this kind of organization. According to the literature consulted, the ISO 9001 standard is recognized worldwide as a quality management system that allow companies to implement possible improvements into the quality processes, fulfilling expectations of clients and at the same time profiling the organizations towards continuous improvement. In this sense, it could be mentioned that the implementation of the ISO 9001 standard in the MSM is, nowadays, one of the primary strategies to manage quality and to accomplish clients’ requirements, mainly in large companies and machinery and equipment sectors, as was stablished in the aforementioned results.

Additionally, this work also remarked that the recognition of the CSFs for the ISO 9001 standard as the essential elements that must be accomplished for its successful implementation. The CSFs could be mentioned as a basic task to facilitate the standard’s adoption, and consequently, to get the benefits it could provide, highlighting an increase in customer satisfaction, the reduction of errors or defects, and also the integration of a culture that is based on continuous improvement as was most frequently reported by the surveyed personnel. If this is adequately managed, it could be converted into competitive advantages. In this case, the leadership and customer focus were found to be the most important factors for the adequate and successful implementation of the ISO 9001 standard in the MSM. In other words, top management should lead the continuous improvement of the company, based on wise decisions, to ensure the engagement of employees to comply with work processes and to always focus on customer satisfaction.

Additionally, some barriers that are difficult for the adoption of the standard were analyzed, and according to the results, the lack of demand by customers to work with the ISO 9001 standard is reported to be the main barrier that could lead to organizations not seeking adoption. Therefore, because of the existence of these barriers, the adequate identification of the CSF is highly important because, by focusing on these key elements, the negative effects of the barriers could be counteracted, thus increasing the probability of a successful implementation, and so, access to the corresponding benefits.

Finally, a model could be fitted to define the relationships among CSFs and potential benefits that were reported in this research; hence, future research should focus on analyzing the factors in developing a Structural Model to help decision-makers determine the activities and actions that must be undertaken to facilitate the adoption of this still broadly used standard.