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ISO 9001 Requirement 4.3 Determining the scope of the Quality Management

ISO 9001 Requirement 4.3 Determining the scope of the Quality Management

In this article we will understand more about how to determine the scope of the Quality Management System and about ISO 9001 Requirement 4.3.

The ISO 9001 Requirement 4.3 exists to determine the scope of the Management System. Fundamental requirement both for audits and for the implementation process, after all, this is where every system will be shaped!

To begin to understand how this requirement works, let’s analyze what the standard says:

Requirement 4.3 – Determining the scope of the Quality Management System

“The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

When determining this scope, the organization SHALL consider:

  1. a) The external and internal issues referred to in 4.1;
  2. b) The requirements of relevant interested parties referred to in 4.2;
  3. c) The products and services of the organization.”


At the beginning of the requirement we have the words that define the scope: “boundaries and applicability”. Therefore, we understand that the scope is who defines what your system should consider, what are its boundaries and how the standard should be applied.

From the scope, we understand which processes are part of the Quality Management System (QMS), which products will be certified. In addition to what may or may not apply, but we’ll get to that later.

ISO 9001 Requirement 4.3: scope of the Quality Management System

Roughly speaking, the scope is a document that will specify the purpose of the QMS, detailing the scope of quality within organizations. The scope is essential documentation for companies seeking to certify and implement the ISO 9001 standard, as it is here that the limits of the QMS are defined.

To determine the scope, one must consider what the potential needs of the interested parties are and what types of products and services the organization has to offer. In addition, you need to carefully analyze the context of the organization.

Determining the scope ISO 9001

Determining the scope is defining exactly where the Quality Management System applies. The scope, then, is responsible for describing, in a simple and summarized way, what your organization is and what it does in a certified way. Let’s imagine a hypothesis:

Suppose an organization manufactures and sells plastic water bottles and cups. At a certain point, it decides that it will certify for ISO 9001, however, it only wants to certify plastic bottles (since it considers itself unprepared to certify both products).

In this case, then, only these bottles will have their quality controlled by the QMS. This is all that will be in the documentation and we say that this company has “closed scope” on water bottles. In this way, the scope of this organization would become “production and sale of plastic bottles”.

In addition, some other information needs to be taken into account, let’s see!

a) The external and internal issues to in 4.1

Everything that can be inferred about how the organization achieves its objectives and goals should be considered.

External issues are those that are not under the organization’s control, such as market updates, economic downturns, rising raw material prices, taxes, and other factors.

Internal issues, on the other hand, are related to what is under the control of the organization, such as the company’s professionals, control of its stocks, materials produced, processes, etc.

b) The relevant stakeholder requirements referred to in 4.2

This is one of the points that should be most relevant when designing the scope. Even though stakeholders may vary for each organization, they are the ones that will, in some way, affect your company’s results.

Here, we can mention people (customers, employees or society), external institutions, government, suppliers, etc. Above all, we must be careful to document which audience we are offering our service or product to, and base our scope on the interests of this audience.

c) The organization’s products and services

This is another important part to determine in your scope. Here is the topic where companies must determine what types of products and services are offered to interested parties. And which ones will be certified and controlled by quality management.

ISO 9001 scope: more clarity for your company

These are some of the most important determinations to be observed when documenting the scope of your certification, and which are also very important during audits.

The scope is an essential part of the management system, as it helps to point out the results the company wants to achieve, define its objectives and document everything the company has to offer.

Keep following our articles to understand more about ISO 9001 and other standards!

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QMS Certification

QMS is an accredited third party certification body, it is currently present in 33 countries and focuses on the certification of management systems. QMS America is managed by the US office and has consistently grown in market recognition by technical level, customer satisfaction and competitive pricing.

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