ISO 9001 - 4.3 Determining the Scope of the QMS

Defining the scope of the QMS includes determining the boundaries of the QMS. This includes the organization’s products, service, operations and locations. Consider both Internal and External factors when defining the scope as well as requirements of interested parties. This step is crucial as it ensures the QMS is scaled appropriately to the organizations long-term strategic goals, products and services. *The scope must be documented and made available to relevant stakeholders and auditors.

In this blog posts we will be discussing scope determination and considering the following:

1. Internal and External Issue Considerations

2. Interested Parties’ Requirements

3. Products and Services

4. Documenting the Scope

5. Reviewing and Revising the Scope

Check out our blog post on How to determine your QMS Scope of Certification

How to determine your QMS Scope of Certification (wilkshireconsulting.com)

4.3 Standard Requirement from Standard (ISO 9001:2015):

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:

a) the external and internal issues referred to in 4.1;

b) the requirements of relevant interested parties referred to in 4.2;

c) the products and services of the organization.

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

Internal and External Issue Considerations

As for considering Internal and External issues, as defined in Clause 4.1 the QMS must reflect the context of the organization. All relevant internal or external factors that may impact the quality management process should be considered and addressing all aspects that could affect quality.

Some Internal factors could include:

· Size and structure of organization

· Complexity of Operations and resources available

· Organizational culture

Some External factors could include:

· Customer / Suppliers expectations and requirements

· Market trends and Industry standards

· Technological advancements

Interested Parties’ Requirements

As stated previously in Clause 4.2 the scope of the QMS must also consider the needs and expectations of interested parties. These parties play a big role in shaping the QMS’s scope and the system having to be able to address their needs. Some examples are:

· Customers

· Suppliers and Contractors

· Employees

· Regulatory bodies

Products and Services

As for products and services by the organization it is pretty straightforward, the organization must define the specific products and services that are covered by the QMS. Some examples of these might include production, testing and shipping processes. The organization must ensure that its scope is properly aligned with all aspects of business that has an impact on customer satisfaction or product quality.

Documenting the Scope

Once the scope is determined, it must be documented and made available to all interested parties, such as auditors, employees and customers.

This documented scope should clearly define the boundaries of the QMS and be very precise. These things should include:

· Products and services

· Locations or departments which the QMS applies

· Any justifiable exclusions

This scope should be included in the Quality Manual and should be easily accessible for audits and reviews.

Reviewing and Revising the Scope

The last step in Clause 4.3 is reviewing and revising the scope. The scope of the QMS is not static and it must be regularly reviewed and updated to reflect changes in the organization. These changes may include:

· Changes in new markets or in regulatory environment

· Changes in Products and services

· Changes in needs and expectations of interested parties such as higher quality standards or customer demands

During management reviews is the best time for the organization to review and revise the scope if necessary to ensure that the scope remains relevant and effective.

Below is a real example scope statement for a business certified to ISO 9001:2015:

Example Scope Statement: ABC Manufacturing, situated in Paris, France, specializes in Estimating, designing, producing, and distributing high-quality automotive components for clients in the European and North American markets.

The core processes of the organization are listed in the scope of certification. In this case, the organizations core processes/activities that produce automotive component include:

· Estimates

· Design

· Production

· Distribution

This scope statement will appear on the organizations ISO 9001:2015 certificate once certified. It will then be clear to other organization review your scope of certification what processes are covered exactly by your certification and what may not be covered.

If for example, the scope didn’t list the design process, but you list it as a service on your organizations website you would then be claiming that you do design when it’s not part of your scope of certification potentially misleading customer. A big No No in the certification world!

Here is an example of the organization processes and how they interact which will be discussed in our next blog post on ISO 9001:2015 clause 4.4 Quality Management System and it Processes.

In conclusion, as 4.3 wraps up clause 4.3 is about defining the organizations scope of their QMS by considering all relevant internal and external factors, interested parties and the products and services that they provide. Ensuring that the QMS is relevant and aligned with the organization’s strategic goals while helping to maintain quality standards and high level of customer satisfaction. In the next blog post we will be diving deeper into on ISO 9001:2015 clause 4.4 Quality Management System and it Processes.

Related Blog Posts:

ISO 9001 – 4.1 Understanding the Organization and its Context

ISO 9001 – 4.1 Understanding the Organization and its Context (wilkshireconsulting.com)

Context of the Organization

https://www.wilkshireconsulting.com/single-post/iso-9001-context-of-the-organization-overview