ISO 9001:2015 requirements include defining the scope of the Quality Management System (QMS). The scope is a relevant part of the quality manual because it outlines how far the QMS applies within the company’s operations.
Furthermore, the scope specifies any exclusion from the ISO 9001:2015 requirements, including justifications. It also clearly defines what a QMS covers within your organization.
Following the updated ISO 900:2015 requirements, QSE Academy has created this article to help organizations understand additional clarification on defining the scope of their Quality Management Systems.
Note that these clarifications will aid to standardize how organizations determine the scope of their QMS, even if they have no quality manual, which is no longer required by the standard.
The ISO 9001:2015 Standard
Section 4.3 of the standard explains the requirements for defining the scope of the Quality Management System.
It states that the QMS can include the whole organization, specifically identified sections of an organization, categorically identified functions of an organization, and more functions across a group of organizations.
QSE Academy reminds organizations to consider the following when developing the scope:
- Internal and external concerns that are significant to the organization’s purpose, the strategic direction, and the capability to obtain desired outcomes.
- Requirements for important interested parties such as employees, suppliers, customers, and stakeholders.
- Products and services of the organization.
Moreover, the scope must cover any requirements of the ISO 9001:2015 standard that can be applied. If a requirement is decided to not apply, an organization must not use this as an intention for not securing the conformity of products and services.
The scope aims to state the products and services covered by the Quality Management System, including justifications for any instances where the ISO 9001:2015 standard cannot be applied.
How the Scope Applies to Organisations
Generally, the scope of the Quality Management System encompasses the whole organization. Note the following exceptions:
- When your QMS only involves one physical location of a multi-site organization, including national and internal locations.
- When your service precisely splits between sectors.
The key is for a scope to establish the physical locations of the Quality Management System, products, or services that are made within the QMS processes, as well as applicable and relevant industries.
QSE Academy reminds us that the scope should be clear enough to determine what your organization does. In addition, your organization must identify which parts are not applicable. For example:
- XYZ Computing provides software development services to companies in the automotive and heavy machinery industries within North and South America.
- ABC Manufacturing based in Tokyo, Japan producing machine components in the automotive sector within Asia.
- ABC Industries located in offices in Asia and Europe provide Information Technology Support to companies in any sector.
- XYZ Consultants is a division of ABC Global that operates in France and produces clothes to the European and North American markets.
How to Develop a Concise and Clear Scope Statement
While the scope doesn’t require a size limit, it should contain sufficient information to identify what is covered by the processes of your Quality Management System.
QSE Academy urges organizations to make a scope that clearly identifies what is included and what is not. This helps interested parties and outside auditors to easily understand your scope.
A concise scope helps your organization focus on Quality Management System efforts, as well as avoid unnecessary questions about activities that may not be applicable to your QMS certification.
How to Define Your Business Scope for ISO 9001:2015
Remember that ISO 9001 requires organizations to define the scope of their businesses when implementing a Quality Management System.
The revised 2015 version of ISO 9001 further clarified how organizations can define the scope, which helped standardize how businesses determine their scope. Section 4.3 of the standard explains what your scope must cover:
-The whole organization
-Specifically identified sections
-Categorically identified functions
– One or more functions across a group
Determining the scope of the Quality Management System according to ISO 9001:2015 should cover:
– The physical sites of your Quality Management System.
– Products and services made within your QMS.
– Applicable industries if relevant.
QSE Academy has toolboxes that can assist your organization in developing a clear scope and identify what your business does. A simple and concise scope can help your organization focus on QMS efforts and achieve company-wide goals.