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

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 define to what processes, locations, products, and services your QMS applies, and this will provide input for the certification body and auditors.

Requirements for the scope in IATF 16949 certification are based mostly on ISO 9001 certification, however, like several different needs, the automotive industry goes a little bit further. Since ISO 9001 certification needs are the first we want to fulfill within the implementation and are not stated in the text of the IATF 16949 certification standard, let’s examine them 1st.

What are the fundamental needs for outlining the scope?

Section 4.3 of the ISO 9001:2015 certification details the needs for determinative the scope of the Quality Management System.

In a note regarding  the QMS, it's declared that the QMS can include the entire 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. Also, 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 certification allows organizations to decide which functions or sections will be included in the scope, IATF 16949:2016 certification 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 certification allows exclusions only from clause 8.3, and even here, with many limitations. The only requirements that can be excluded are related to the 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's a necessity to document the scope; not like  ISO 9001 certification, that doesn’t specify wherever and the way  IATF 16949 certification needs the Quality Manual to incorporate the info about the scope and justifications for any exclusions. For additional info on the IATF 16949 Quality Manual, see A way to write the IATF 16949, Quality Manual.

How does IATF 16949:2016 certification 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 producing  or service is clearly  split between industries (e.g., in a plant with three assembly lines wherever assembly lines one and a pair of  are for automotive, and want to possess  a QMS certified to the ISO/TS 16949 Quality Management System standard for automotive,

but you want line three to be certified to ISO 9001 as a result of several of the automotive necessities that don't apply).

So, your scope should establish the physical locations of the QMS, merchandise or services that are created within the QMS processes, and therefore the applicable industries, if this is often relevant.

It should be clear enough to spot what your business will, and if not all components of the business are applicable, it should be identified clearly which parts are.

Make your scope statement clear and concise

Your scope doesn't have a size limit and may include enough data to see what's 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 parties? 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 apply to your QMS certification.

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