Context of ISO organization

What is the context of the ISO 9001 organization?

The context of the organization describes internal and external issues that can affect the quality management system of companies. In many companies, quality management has little in common with actual practice – many employees mentally separate both aspects from one another. For example, implausible processes are dismissed with the phrase “This is what quality management wants from us.” The reason for this separation is that QM often runs alongside everyday practice. Such interlocking is essential for the effectiveness of quality management.

To counteract this problem, we find certain requirements in the QM standard ISO 9001, through which the determination of the context and the definition of the area of ​​application can be better implemented in practice. According to the standardized high level structure, the section “context of the organization” is also an integral part of the ISO basic structure for management systems. Due to the new requirements for the area of ​​application, companies that want to manage or implement a QM system in accordance with ISO 9001 must continue to think outside the box.


What requirements does ISO 9001 place on the context of the organization?

With regard to the determination of the context, ISO 9001 requires that companies determine and evaluate the influencing factors that are relevant for them and affect the ability to achieve the intended quality goals. This is how companies should determine the “meaning” – so why they are active. Through the connection to the strategy of the company and its implementation, the ISO 9001 again clarifies the entrepreneurial approach and the responsibility of top management in the management and implementation of the quality management system.

If influencing factors are relevant, this means that they can influence a company’s ability to continuously deliver products or services that meet customer expectations and the requirements of laws and authorities. In terms of influencing factors, ISO 9001 differentiates between internal and external issues:

Internal topics: are factors that can result from corporate culture, values ​​or corporate performance.

External topics: can arise from economic, cultural, legal, technical or even competitive contexts.


Fulfilling the ISO 9001 requirements breaks through barriers

As already mentioned at the beginning, the conceptual barrier between the quality management system and practice must be broken in order to effectively implement the QM regulations. The individual situation of the company should therefore be carefully analyzed so that the quality management can be designed individually and according to requirements. In ISO 9001, section 4 “Context of the organization”, requirements can be found that must be met in order to understand the company and its environment:

4.1 Determination of both external and internal issues with relevance

4.2 Understanding interested parties as well as their requirements and expectations

4.3 Defining the scope of the QM system ISO 9001

4.4 Realizing and maintaining the quality management system and its processes

With the specifications for points 4.1 and 4.2 you will then receive the reason why the QM system is as it is current with regard to points 4.3 and 4.4.


What are “Interested Parties” in the context of the organization?

What is the context of the organization and what are interested parties in the quality management system?

The term “interested party” – referred to in English as stakeholder – does not only include a company’s customers. Rather, according to ISO 9000, this refers to all persons or stakeholder groups who can have a (potential) influence on the quality capability of the respective company. If the requirements and expectations of interested parties are ultimately not met, this can, according to the definition of ISO 9000, “pose a significant risk to the sustainability of the organization”. Interested parties thus have a direct or indirect effect on the success of companies. In order to minimize the risk, ISO 9001 requires that interested parties and their requirements relevant to the QM system must be identified. Interested parties include, for example:

  • customers
  • owner
  • Organization staff
  • Suppliers
  • partner
  • Banks
  • society

These interest groups are usually also broken down into internal and external stakeholder groups:


Internal area …

… is controlled by the organization. Who is directly involved in the creation of the product or the provision of services?


External, close area …

… cooperates with the organization. Who influences product manufacture or service provision?


External, remote area. ..

… is indirectly connected to the organization. Who is or feels affected by the activities of the organization?


The connection between the organization and its interested parties is often dynamic, meaning that positions can change quickly, for example. For this reason, it is imperative that the organization implements sustainable processes in order to continuously monitor the interested parties and their needs and expectations. Ongoing monitoring of stakeholders should be done on a strategic level. This means that appropriate measures can be taken quickly to respond to changing requirements.


How can we determine the context of the organization under ISO 9001?

When companies determine the context of the organization, the ISO 9001 company gives them a lot of leeway. Different methods can be used depending on the type and size of the company. Determining the context in a team has proven to be a simple method. A checklist with these typical questions on internal and external topics can be used:

What is the market asking for?

Are social changes foreseeable?

Are there any new processes or technologies that affect us?

So are legal changes relevant to us?

How are the general economic conditions developing?

Are there also requirements for our performance?

What values ​​is our corporate culture based on?

Are internal relationships relevant for us?

Following this, the checklist can be expanded to include questions to identify the interested parties. Particular attention should be paid to the main requirements of the interested parties:

Are certain patterns of action to be expected from the interested parties?

Which strategies are suitable for dealing with the stakeholders and their requirements?

Do we have to consider certain needs when finding a solution?

What other conflicts should we prepare for?

Are there any risks that need to be managed?

Which success factors have to be considered?


The ISO 9001 context of the organization should always be defined as a controlled document and also made known in the company. In this way it becomes an effective quality management tool, e.g. for:

  • Quality planning
  • Definition of the quality policy
  • Deriving the quality goals
  • Process optimization
  • Orientation of the employees with regard to the meaningfulness of the activity
  • Consideration of risks and opportunities

When determining the stakeholders, it should be taken into account that different interested parties can make different and sometimes contradicting demands on the company. It is possible that the stakeholders of the organization are benevolent and supportive or skeptical and obstructive.