Understanding the organization and its context

ISO 9001:2015 specifies requirements for a Quality Management System when an organization:

Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO 9001:2015 is an international standard that sets out the criteria for a quality management system. One of the key requirements of this standard is understanding the organization and its context.

The context of the organization requires the organization to evaluate itself and its context.

This means that you need to define the influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives, and goals, the complexity of products, the flow of processes and information, the size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities in the business context.

Where to start?

Although the standard doesn’t prescribe a method for determining the context of the organization, there are some logical steps and milestones:

What are internal and external issues?

This requirement seems too general, and there is a risk of going too wide when defining the internal and external issues. In fulfilling this requirement, you should focus only on issues that can affect customer satisfaction and delivery of quality products and/or services.

An organization’s internal context is the environment in which it aims to achieve its objectives. Internal context can include its approach to governance, its contractual relationships with customers, and its interested parties. Things that need to be considered are related to the culture, beliefs, values, or principles inside the organization, as well as the complexity of processes and organizational structure.

To determine the external context, you should consider issues arising from its social, technological, environmental, ethical, political, legal, and economic environment.

Examples of external context may include:

• Government regulations and changes in the law.
• Economic shifts in the organization’s market.
• The organization’s competition.
• Events that may affect the corporate image.
• Changes in technology.

Basically, all this information is in the heads of the CEO and other members of management, but it was never put on paper; the best way to gather it is by organizing some brainstorming. Systematization of all this information can be very valuable and demonstrate where you stand as an organization.

Should we care about other people’s opinions?

In simple terms, the requirement for identifying relevant interested parties means that you need to decide whose opinion of your company you should care about.

Interested parties include direct customers, end users, suppliers and partners, regulators, and others. Others could include people in the organization, owners/shareholders, and even society. These parties add value to the organization or are impacted by the activities within the organization. Identifying and meeting their needs is important to implement an efficient and effective quality management system. Their feedback can really help you to determine what can be improved in your organization, and how.

Let’s put it on paper

Once all this information is gathered, it should be documented; the standard is pretty explicit about it. But where it should be documented? The first choice is to create a new document, and this document will be something that the certification body will require instead of a Quality Manual prior to the audit. The second choice is to include these new requirements in the existing Quality Manual. This can be very practical since the Quality Manual contains some of the old requirements, so you’ll only have to add the part with internal and external issues and interested parties. Another advantage of this approach is that everyone is already familiar with the Quality Manual, so it wouldn’t be a great change in documentation structure; also, the certification auditors may ask for it out of habit.

Regular management review

Last, but not least Regular management review is necessary to monitor the organization’s internal or external issues. Once the internal context is understood, management can conduct an external analysis using “PEST” (political, economic, social, technological) and SWOT (strengths, weaknesses, opportunities, threats) analyses and really benefit from this new requirement, instead of just formally fulfilling it.

The context of the organization seems like one of the “document and forget about it” requirements, but it shouldn’t be. Information gathered through defining context can be very useful for identifying room for improvement, and it shouldn’t be taken for granted. Knowing the context of your organization and the opinions of your interested parties can help you improve your organization and make it even better.

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