The new requirements of ISO 9001:2015 are sometimes enigmatic. I will try to clear them up. I begin with the context of the organization.
Many of the new concepts in ISO 9001:2015 were introduced in it in relation to the risk management. So it is with the context of the organization. The standard requires that the organization has determined what in its external and internal environment is important to the realization of its objectives, strategy and to achieve the intended effects of the quality management system [ISO 9001:2015, p. 1]. Environmental factors should be monitored. And that's all. The company's management is left alone with that ambiguous requirement. Fortunately, there is a solution - ISO 31000:2009. It was not referred at this point in ISO 9001, but for those who are familiar with the terminology of risk management, the relationship is obvious. I shall therefore address the requirements of ISO 9001:2015 from this point of view.
Determination of the context of the organization should be the first step while developing a risk management model in the company. And even more, it should be the first step in construction of any management system, including quality management system. Only then you can we develop a system that will be tailor-made. You can have a naive hope that this requirement will limit the implementation of systems by copying documentation. Unfortunately, this will not happen, because few certification companies can afford to raise the requirements (read: to lose their customers).
The external context can include, among others, factors: cultural, social, political, legal, financial, technological, economic, environmental. The organization should monitor trends in the business environment, and also take into account relationships with external stakeholders [ISO 31000:2009, p. 10]. Therefore, while building quality management system, the management must consider what in the environment can be particularly important for the company. These factors should be determined at the beginning of implementation. They should have an impact on the construction of the system. Some examples:
- In company's environment there is a strong and active environmentally friendly society. By implementing a QMS we should therefore place emphasis on goals, processes, tasks, areas that can have a negative impact on the environment.
- On the market there are modern technologies, the purchase of which can positively affect the functioning of the company. Even if you can not afford it now, it is good to so design a system that was prepared for implementation in the future.
- The purchasing power of our clients decreases. We should modify level of product quality (or launch a new product with a certain level of quality) that will satisfy the needs of customers while lowering prices. I'm not talking about lowering quality, but matching the level of quality - are two different things.
The internal context consists of, i.a.: organizational structure, job descriptions, strategy and goals, the potential of the organization (technical, people, resources, knowledge, etc.), information system, relationships with internal stakeholders, organizational culture, standards, business contracts [ISO 31000:2009, p. 10]. While to the external factors we have to adjust, the internal can largely be modified. Depending on the organization's potential and the ability of managers we can adapt to their environment or to set new trends. Let's look at some examples:
- Our technological level is lower than competitors'. At the same time we can not afford to purchase new technologies. We must therefore adapt our processes to obtain the desired quality using current technologies. It is worth noting that Toyota has done with this a competitive advantage - using versatile machines they increased the flexibility.
- The flow of information is ineffective. In designing the new QMS we should pay attention to improving the system of communication. If we consider computerization in this regard, it should be delayed until the communication processes become truly effective. Computerization is like placing the concrete - when it bounds, nothing can be changed.
ISO 9001:2015 does not specify the method of documenting the context factors. A good place for them are documents related to the strategy of the organization. Knowledge of the organizational context is crucial when making a decisions in each part of the organization, not only in terms of quality.
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Photo: Jason Taellious, Flickr, CC