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5 Steps to Identify and Write the Context of the Organization for ISO 9001

Clause 4 of ISO 9001 requires an organization to evaluate itself and its context to define the effects of various elements on the organization. This includes how internal and external issues influence its culture, organizational goals, products, process flow, markets, customer information, and more.

How to Identify and Write the Context of the Organization in ISO 9001

By defining the organization’s context, a company takes the first step to detect risks and opportunities in the business context. Today, we’re going to guide you through how to write the context of your organization in its ISO 9001. If you write a good Context section, you’ll be well on your way to achieving ISO 9001 certification for your company.

examples of context of the organization

More about ISO 9001 for businesses:

Have you ever heard of a QMS, or quality management system? Well, ISO 9001 is the international standard for quality management, and it’s a very good idea to get certified. If you are a production company of any sort as, you should read up on the ISO 9001 Standard to make sure your business follows the requirements. After all, your main goal should be to show potential customers that they can depend on you to consistently produce quality goods.

Within the scope of QMS systems and certifications, there are actually a number of other ‘9000’ level forms that could be good for businesses to fill out. However, the 9001 is currently the only one in the 9000 family to offer official certification for organizations. So, it’s important for a company to be able to say that they are ISO 9001 certified!

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Does your business need an ISO 9001 certification?

Now, you might be asking yourself if your organization meets the criteria for achieving and maintaining ISO 9001 certification. The great news is that no matter the size or your organization, it’s eligible for certification if you follow the protocols. Whether your company employs 1, 10, or 10,000 people, you can register it for certification with ease.

Context section:

The context of your organization, in layman’s terms, entails defining any potential issues with the quality of your products, and how they might affect your consumers. This is not to say that these issues happen, but you have to analyze the possibilities of them happening based on your company’s operations. When defining the context of your organization in the ISO 9001 forms, you need to be honest, realistic, and analytical about the way your company manages its product quality.

Though there’s no standard method prescribed for determining the context of the organization, some coherent steps and can make the process smooth and error-free; here are these coherent steps:

Step 1- List internal and external issues that can affect the customer satisfaction and delivery of the quality product and/or service:

Internal issues may include the approach to governance, contractual relationships with customers, the complexity of processes, organizational structure, culture, beliefs, values, or principles inside the organization.

The external issues may include social responsibility, environmental issues, ethical concerns, political stability, legal framework, technological challenges, and the economic environment.

The CEO and senior management heads surely know and have access to this information. However, they sometimes do not document it properly. To start on this step, you need to organize brainstorming sessions and list everything that appears in these sessions!

Step 2- List the interested parties whose opinion about your company should be cared about:

The owners and the shareholders are the key people to give their opinion, but people actually matter for the organization. They may include your customers/end users, suppliers, and partners, regulators, etc., as well as a society! Feedback from all these sources helps an organization determine what can be improved and how.

The opinion of all such people adds value to the organization. By identifying and meeting their needs, you implement an efficient and effective quality management system.

You can conduct short yet effective surveys to gather the opinions of interested parties.

Step 3- Identify the scope of the quality management system:

Other than the internal & external issues and interested parties, there must be a defined extent or boundary for which the organization is getting certified.

While determining the scope of the QMS, you must consider all the requirements of relevant interested parties and explain that every ISO 9001 requirement is mandatory and may only be excluded if it cannot be applied.

Step 4- Get ready to put everything on paper:

The above three steps are all about brainstorming and gathering maximum information. Once the information is gathered, documentation is a must, and the standard is apparent. However, the documentation procedure is extensive and may require hard work if you don’t use the right tools!

 Step 5- Write the context of the organization using MyEasyISO:

MyEasyISO enables you to define and write the context of the organization in the simplest way possible. Document the context of your organization using MyEasyISO’s step by step module.

Acknowledge and define any internal and external issues that may affect your organization and list out the risks associated with each issue.

myeasyiso context of organization external issues

Define the stakeholder/interested parties’ names and provide details about what you’ll expect/ need from them. Detail how it may impact your organization and list out risks associated with stakeholder/interested parties.

myeasyiso context of organization interested party

Define the scope of QMS for which your organization is getting certified. List out the excluded clauses and justify that with a reason for each.

myeasyiso context of organization scope

Here are more detailed insights into the module:

myeasyiso context of organization 3

context of the organization template

Even if you’re not much familiar with the documentation procedure, you can do it perfectly. Use MyEasyISO as it comes with quick help about each feature.

sample context of the organization

Flowcharts, procedures, and forms related to context can be captured in a documented information module. A highly professional document can be downloaded with a single click!

Sign up for free and test MyEasyISO yourself to see how it can save you time and money!


So, now you probably have a better understanding of what ISO 9001 certification is, what the benefits are, and how to achieve it. We hope that this article provided you some valuable insight into what you can do to write your organization’s ISO 9001. These details can be complicated when running a business, but they are crucial. So, get to writing and see if MyEasyISO is right for you. We love it!

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