ISO 9001:2015 in Plain English by Craig Cochran provides a detailed explanation for the international standard document of the same name. According to the author, one of the triggering factors to write this book was his own experience of reading the original version back in the 1980s, when his enterprise needed certification. Since the original ISO 9001 documents may be highly confusing to the general audience, a translation into plain English is very helpful indeed.
Cochran’s book not only delivers the material in a comprehensible and easily memorable way but also accompanies it with vivid details and real-world examples, thus rendering the document accessible to everyone.
Cochran’s book comprises nine chapters and three appendices. The first eight chapters cover all the information from ISO 9001:2015, starting from its introduction and gradually disclosing its ten sections. The author briefly describes sections 1–3, and then focuses in more detail on sections 4–10, since they contain the provisions of ISO 9001:2015, requiring compliance. The author carefully follows the structure of the original ISO 9001:2015, retaining its order and numbering scheme. However, in Cochran’s book, each paragraph of the standard acquires an in-depth analysis, profound commentaries, and answers to frequently asked questions. Moreover, the author further elaborates on the specific nature of ISO 9001:2015 in chapter 9 and the appendices of his book.
ISO 9001:2015 introduces several new aspects as compared to the previous versions. These include the increased focus on the context and interested parties, the highlighted role of risk-based thinking, process validation, and documentation flexibility. Among other significant supplements in ISO 9001: 2015 are actions to remove human error, the involvement of the Quality Management System, and leaders’ accountability for it, as well as advocating the process approach. All these additions constitute a strong basis for organizations to function successfully with due account for the requirements of the modern world.
As one can easily observe, this document strongly relates to the ideas from Dr. Juran’s quality trilogy in terms of quality planning, improvement, and control. For instance, ISO 9001:2015 foregrounds the significance of identifying one’s customers and determining their needs. Furthermore, the document requires to design of a feasible process of production. Besides, ISO 9001:2015 prioritizes achieving the reliability of the production process.
One of the fundamental aspects of ISO 9001:2015 is the emphasis on understanding the organization context, which is an entirely new idea as compared to the previous version. For this purpose, it is necessary “to explore the major elements of its internal and external environment” (Cochran, 2015, p. 15). Subsequently, one needs to provide an impartial and unbiased assessment for the current situation inside and outside the organization. Indeed, understanding the organization and its context promotes the elimination of one’s weaknesses and reveals the competitors’ vulnerable spots. It also prioritizes the analysis of the stakeholders’ needs, expectations, and satisfaction level. Hence, self-analysis is of paramount importance since it is the prerequisite for progress and success.
Furthermore, understanding the organizational context helps to identify the potential gaps in the marketplace and thus to attract new customers. For instance, a gap analysis can significantly streamline the managerial process by listing a set of questions, which “can be answered with a yes/no/qualified yes” responses (Watkins, 2016, p. 26). More specifically, it can effectively juxtapose the current circumstances against the posed requirements.
As one can easily observe, ISO 9001:2015 loosely relies on the SWOT analysis pattern. It is also evident that understanding the organization context eventually increases the competitiveness of the organization, which renders this new element a valuable supplement to ISO 9001:2015.
It is necessary to point out that understanding the context is essential for long-range strategic planning since it significantly broadens the scope of the organization. That is to say, it covers various driving forces in the dynamic and multifaceted world of today, including legal, financial, societal aspects, as well as other important contributing factors. For instance, the study by Fonseca and Domingues (2017) found a direct correlation between “the capability to understand the context and both the ability to change and the achievement of improved performance and results” (p. 453).
Therefore, the organization’s ability to analyze the broader context is a cornerstone of success in “the present digital age” (Fonseca & Domingues, 2017, p. 453). Thus, understanding the organization and its context is crucial in the modern world of “turbulence and unpredictability” (Cochran, 2015, p. 17). By taking into account a wide range of features in terms of the external environment and internal culture, the organization can quickly and efficiently respond to any changes, new tasks, and emerging challenges.
Another significant remark in ISO 9001:2015 is the necessity to align the organization’s quality policies with its identified context and strategies. This element naturally follows from the ability to understand one’s context, as it strongly relies on the self-analysis and internal culture. The author asserts that “the age of generic quality policies is over” (Cochran, 2015, p. 218). In other words, the quality policies must be adaptive for the organization, its distinctive features, relevant needs, and strategies.
The same requirement pertains to the quality objectives of the organization. In contrast to previous versions, ISO 9001:2015 prioritizes the necessity for feasible plans and specific algorithms of actions to achieve these objectives. The document suggests a personalized and thus more meaningful approach, requiring an increased level of proactivity.
The risk-based approach is another essential element of ISO 9001:2015. In contrast to the previous versions, the document has undergone essential transformations by moving from an implicit idea about risk management to the concept of risk-based thinking as an explicit requirement. According to ISO 9001:2015, the actions to address risks should be fulfilled by defining “problem areas in the processes and possible potential opportunities for improvement” (Hrbáčková & Tucek, 2019, p. 74).
Hence, risk-based thinking serves as an effective means for prognosis and prevention of potential problems. This approach provides the organization with a possibility “to determine the factors that could cause its processes and its quality management system to deviate from the planned results,” and ultimately to take full advantage of opportunities if and when they come into play (International Organization for Standardization, 2015, p. 6). As one can easily observe, risk-based thinking is a vital prerequisite for an effective quality management system. Elimination and prevention of undesirable outcomes ensure the continuous development of the organization.
Process validation is another important aspect, which implies ensuring that the production outcomes are fit for their target purpose and appropriate use. In particular, the book provides guidelines on process validation for organizations whose products are not liable to verification before the consumption. Such circumstances can arise either due to a lack of existing technologies or because of the nature of products as such. The author states that making decisions in performing process validation is the domain of the organization’s responsibility.
Therefore, validation should be applied “as the organization sees fit” (Cochran, 2015, p. 230). Moreover, since ISO 9001:2015 does not “explicitly require records,” organizations “should define exactly what records will be maintained as part of process validation” (Cochran, 2015, p. 233). In other words, the standard provides autonomy and flexibility in terms of process validation.
Furthermore, ISO 9001:2015 also implies a more flexible approach in terms of documentation and keeping records. In other words, process documentation should be present insofar as required. Hence, the organization should decide whether a specific type of records is needed. ISO 9001:2015 remarks that the more voluminous the organization’s documentation becomes, “the less likely employees are to use or understand it” (Cochran, 2015, p. 105). Such a facilitated hierarchy of documentation aims at ensuring a more efficient management design. Moreover, it promotes the computerization of the production processes, which is also essential in the digital world of today.
It is also necessary to mention the requirement to eliminate human error. The author provides an extensive guideline for this purpose because “human error is an inevitable part of life” (Cochran, 2015, p. 151). Indeed, the book provides several practical methods to organize the error-proofing process. For instance, the author recommends to assign specific locations to instruments and facilities, to use check-lists of required actions instead of relying on one’s memory, to divide tasks into smaller parts, to make emergency shut-downs, and so on (Cochran, 2015, p. 152).
In such a manner, human errors can be minimized and eliminated. This achievement, in turn, will contribute to the overall quality of the process. Furthermore, the author emphasizes that the techniques mentioned above are by no means rigid and universal. Instead, it is advisable to adjust and modify each of them to the organization’s specific features and needs.
Accountability of the organization’s leadership for the Quality Management System is another vital addition to ISO 9001:2015. It places responsibility for the entire process upon the shift leader, rather than the quality manager or anyone else involved (Cochran, 2015, p. 37). Moreover, Quality Management System should closely relate to the organization’s decision-making and problem-solving procedures. In such a manner, this addition ensures that ISO 9001:2015 would be a functional tool for efficient management and not merely a decorative certificate. Furthermore, advocating the process approach is also prioritized in ISO 9001:2015.
The process approach virtually implies the management of a specific activity as an indivisible phenomenon. That is to say, each project should be regarded “from start to finish… including inputs/outputs, resources, monitoring, measurement, improvement, training, and other considerations” (Cochran, 2015, p. 39). In this context, the organization’s leadership must have a clear comprehension of the entire process. Hence, the holistic understanding of each particular activity is of paramount importance.
Thus, ISO 9001: 2015 includes several new elements, which are essential for management in the modern world. These include an increased role of the organization context, due attention to the stakeholders’ needs, a risk-based approach, validation of the process, and streamlining the documentation procedures. ISO 9001: 2015 also advocates the process approach and avoiding human error, involving the Quality Management System at all stages of production, and placing responsibility for its implementation on the organization’s leaders. Craig Cochran’s book, in turn, enables a clear understanding of all these requirements, which is particularly relevant in today’s accelerating world, where the immediate access to information and the ability to apply it practically are of great worth.
References
Cochran, C. (2015). ISO 9001:2015 in plain English. Chico, CA: Paton Professional.
Fonseca, L., & Domingues, P. (2017). How to succeed in the digital age? Monitor the organizational context, identify risks and opportunities, and manage change effectively. Management & Marketing, 12(3), 443–455. Web.
Hrbáčková, L., & Tucek, D. (2019). An analysis of two new process approach-related terms in ISO 9001:2015: risk-based thinking and context of the organization. Scientific Papers of the University of Pardubice, 27(45), 65–76.
International Organization for Standardization. (2015) Quality Management Systems – Requirements (ISO standard no. 9001:2015). Web.
Watkins, S. (2016). ISO 9001:2015: A pocket guide. Cambridgeshire, England: It Governance Pub.