The quality management system of an organization is influenced by the environment in which it operates and by the changes that occur in that environment. This means that we should not set a goal and proceed to achieve it without considering what could happen and what might affect what we are trying to do.
For those organizations whose goal is to continue delivering the same products and services in the same markets, this statement might even seem ridiculous as they may have walked down this same path many times before without any problem and could, therefore, simply continue doing what they have always done by following their proven policies and practices aimed at satisfying the customer with what they receive.
However, with each new order, they consciously assume that nothing has changed or will change in the short term and, eventually, they may find out that their customers have found a supplier who offers something different and attracts them more. This is why paragraph 4.1 of ISO 9001:2015 asks for an analysis of the context in which the organization operates to identify those factors capable of influencing its ability to provide the expected results and to determine how significant they are. Many sections of the standard are connected to this very important point:
- paragraph 4.2, which asks to understand needs and expectations;
- paragraph 4.3, which specifies that the purpose of the quality management system must be established;
- paragraph 4.4.1, which indicates determining the processes;
- paragraph 6.1, which requires managing risks and opportunities;
- paragraph 8.1, which discusses operational planning and control;
- paragraph 9.1.3, which addresses analysis and evaluation;
- paragraph 9.3, which discusses management review;
- paragraphs 10.1 and 10.2, which address the topic of improvement
Regarding context analysis, the requirements are of two types, as the standard requests to:
- determine internal and external issues;
- monitor them over time;
The identified and monitored issues must be relevant to the organization’s purpose, that is, the very reason for its existence, and this could already raise the first problem as there may be differing opinions on the purpose, depending on how one views the organization. The matter becomes clearer if we understand that it is not the products or services that an organization produces that define its purpose, but the value that its customers derive from owning them.
If we perceive the organizational purpose as mere economic performance, it is obvious that it will never change, but if the purpose becomes acquiring and maintaining a customer over time by satisfying them, what customers value will inevitably change over time, and therefore, the organization’s purpose must change in response to external environmental changes.
The response to the context in which an organization operates is the strategy, that is, an action plan that explains how, among all the alternative paths it faces, the organization has chosen one specific way to achieve its purpose. Strategy is the next step after a strong vision and serves to connect objectives to the company’s core values, explaining how it intends to proceed to achieve the vision it has in mind.
A quality management system is not a set of requirements or procedures to comply with but a systemic view of an organization on how it intends to acquire and retain customers over time. This systemic vision culminates in a strategy, which is nothing more than a model that originates from imagining how the organization seeks and pursues its objectives. And since one of the main goals of companies is the consistent delivery of products and services that meet customer requirements and regulatory and statutory obligations, it is obvious that this is one of the expected results from applying a quality management system.
Paragraph 0.1 of ISO 9001:2015 explains that other expected results may include demonstrating compliance with ISO 9001 certification and increased customer and stakeholder satisfaction.
The main reason why it is necessary to determine issues related to context is to demonstrate that the organization has prioritized the appropriate actions and is therefore able to function as a system of properly interconnected elements to achieve the results it has anticipated. However, each organization is different, and its diversity must be translated into how it believes certain issues impact its ability to carry out the work that awaits it. This is why each quality system should be unique and perfectly tailored to the needs of a particular company. The quality system of an organization cannot be cloned if it is to work effectively in another company.
Some routines will work effectively even if reproduced in multiple environments because they address the same situation, but there are too many variables to expect that all strategies, policies, objectives, and processes of one organization will work just as well in another.