The new ISO 9001:2015 recognizes that all organizations are formed for a specific purpose, pursue a particular strategy, and are aware of issues that may act as drivers or obstacles to achieving the objectives they have set and how to address them.
The purpose, strategy, and identification of relevant issues within the context in which they operate all stem from a strategic planning process that begins with the following actions:
- clarify their purpose (what do we do? What are we trying to achieve? We should then ask ourselves how we do it, i.e., through which methodologies);
- study the context in which we work (who are we doing it for? Who are the stakeholders, i.e., those who, internally or externally, can influence what we are trying to do? What is the nature of these internal and external influences? What is the relationship between these sources of influence? What changes have occurred in the needs of the stakeholders in relation to the organization's purpose? But also, what is critical to our success? What external and internal factors or issues may hinder or facilitate the achievement of our purpose?);
- develop a strategy and the consequent policies, actions, and measurements.
To develop an effective quality system, it is, therefore, necessary to have a broad view of the context and understand it within the organizational system, of which the management system becomes a sort of subsystem. To identify the issues related to the context, various techniques exist. The most commonly used to identify external factors is a PESTLE analysis, while for internal factors, there is the SWOT analysis. However, neither PESTLE nor SWOT provides a comprehensive view of the systemic relationships between the various components of the system, which would be crucial in studying the context.
PESTLE
The PESTLE analysis is an excellent tool for studying the external factors of the context, but showing on a 4x4 grid how all these factors interact is almost impossible, even though these relationships would be the ones to study because they could impact the organization's ability to achieve a result. This is why, before applying PESTLE, it is necessary to create a map of the external system, placing the organization at the center, and then, through a brainstorming session conducted by the team responsible for identifying the external stakeholders with whom the organization has a relationship (both directly and indirectly), list all the stakeholders. Within this list, there will be some parties whose influence is more significant than others, and this is the role the map should play: identifying them.
Subsequently, we must realize how these parties are connected to our organization and to each other, as this affects the relationship we have with them. Finally, we need to include in the map any significant influence from the natural environment or infrastructures. Only at this point will we have a structure in which to apply the PESTLE analysis to determine the nature of individual influences.
The PESTLE analysis is used to study the market of a particular organization and gets its name from the adjectives:
- political
- economic
- social
- technological
- legal
- environmental
This type of analysis helps identify what is happening in the external environment of an organization and the factors that could influence its future direction.
SWOT
Even before applying a SWOT analysis, it is good to create a map, this time internal to the organization. The questions to ask will be:
- What can we influence among the factors that may affect our ability to achieve the goal we have set and pursue our strategy?
- How are these factors related?
- How are these components related to the sources of external influence?
The answers derived from the questions we ask ourselves to create the map of external and internal influences will help us list all the tangible and intangible components that constitute the organization as a subsystem operating in its context (the system). Everything the organization cannot influence or has little influence on should be listed in the external environment, while the factors the company can directly influence should be included in the internal issues.
Obviously, in these maps, only significant connections should be indicated, because the complexity of an organization is often so large that, otherwise, we would risk getting lost in details irrelevant to our analysis. At this point, we will have a structure to apply the SWOT analysis to determine the nature of the influences.
The SWOT analysis gets its name from the initials of the English words that stand for:
- the strengths of the organization
- its weaknesses
- opportunities (which come from the external environment)
- threats (which also come from the external environment)
Without a clear understanding of an organization’s strengths, weaknesses, opportunities, and threats, strategies may fail, and objectives may not be achieved. If PESTLE influences SWOT, the opposite cannot be said. The SWOT analysis, in fact, is similar to an assessment of an organization's capabilities. The results are often extremely subjective and will vary depending on who conducts the analysis, which is why it is better to have a heterogeneous group of people perform it.