How to define scope of the QMS according to IATF 16949:2016

In order to establish a QMS (Quality Management System) according to IATF 16949, you first need to define everything the QMS will apply to. This requirement is nothing new to quality standards, or any other management system standard, for that matter. Although it seems like just a formality, defining the scope is one of the crucial steps in the implementation and ongoing maintenance of the QMS. You will basically define to what processes, locations, products, and services your QMS applies, and this will provide an input for the certification body and auditors.

Requirements for the scope in IATF 16949 are based mostly on ISO 9001, but as with many other requirements, the automotive industry goes a bit further. Since ISO 9001 requirements are the first we need to meet in the implementation, and are not stated in the text of the IATF 16949 standard, let’s examine them first.

What are the basic requirements for defining the scope?

Section 4.3 of the ISO 9001:2015 standard details the requirements for determining the scope of the Quality Management System. In a note about the QMS, it is stated that the QMS can include the whole organization, specifically identified functions of the organization, specifically identified sections of the organization, or one or more functions across a group of organizations. To start, there are three considerations to be included when determining the scope:

  • external and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results
  • requirements of relevant interested parties
  • the product and service of the organization

In addition, the scope must state the products and services covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be applied—but this requirement is further limited by IATF 16949, as you will see below.

What are the supplemental requirements to be met?

Although ISO 9001 allows organizations to decide which functions or sections will be included in the scope, IATF 16949 requires supporting functions, whether on-site or remote, to be included in the scope of the QMS. Supporting functions can be design centers, corporate headquarters, and distribution centers. This leaves far less freedom for the organization when defining the scope, and the aim is to ensure that all operations that affect the quality of products and services and/or customer satisfaction are included in the QMS scope. This will make the implementation much harder for some organizations, especially for big companies that have many locations on several continents.

Customer-specific requirements also need to be evaluated and included in the scope of the QMS. In practice, this means that the organization will have to consider these requirements, and see how they reflect on the QMS and act accordingly. For some organizations, this won’t bring anything new; however, for companies where their customers define processes, products, or services it means that they will have to include all of this in the scope of the QMS.

Furthermore, the standard in this section defines the exclusions. IATF 16949 allows exclusions only from clause 8.3, and even here, with many limitations. Basically, the only requirements that can be excluded are related to design and development of products and services. Permitted exclusions do not include manufacturing process design. Naturally, the organization will also have to provide and document justifications for exclusions.

Finally, there is a requirement to document the scope; unlike ISO 9001, which doesn’t specify where and how, IATF 16949 requires the Quality Manual to include the information about the scope and justifications for any exclusions. For more information on the IATF 16949 Quality Manual, see: How to write the IATF 16949 Quality Manual.

How does this apply to my organization?

Usually, the scope of the QMS covers the entire organization. Some noted exceptions are when your QMS only covers one physical location of a multi-location company, or when your manufacturing or service is distinctly split between industries (e.g., in a plant with three assembly lines where assembly lines 1 and 2 are for automotive, and need to have a QMS certified to the ISO/TS 16949 QMS standard for automotive, but you want line 3 to be certified to ISO 9001 because many of the automotive requirements do not apply).

So, your scope should identify the physical locations of the QMS, products or services that are created within the QMS processes, and the industries that are applicable, if this is relevant. It should be clear enough to identify what your business does, and if not all parts of the business are applicable, it should be identified clearly which parts are.

Make your scope statement clear and concise

Your scope does not have a size limit, and should include enough information to determine what is covered by the processes of the QMS. However, it is important to make clear what is included and what is not. If it is not clear to you what processes in your company are covered by your QMS, then how will it be clear to an outside auditor or other interested party? Making your scope statement simple and easy to read can help to focus your QMS efforts, and prevent unnecessary questions about activities that may not be applicable to your QMS certification.

Use this free IATF 16949:2016 Implementation Diagram to implement IATF 16949:2016.

Advisera Strahinja Stojanovic
Strahinja Stojanovic

Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.