How to determine your QMS Scope of Certification



Clause 4.3 of the ISO 9001:2015 Quality Management System (QMS) Standard requires that the organization determine the boundaries and applicability of the QMS. Additionally, this clause requires that the organization document this in the form of a defined scope. But how does an organization go about doing this?


I generally advise that organizations put together a list showing an overview of the all the core processes/activities that an organization performs that contribute to their product or service. For example, an organization may have the following core processes:


· New Business Acquisition

· Engineering and Design

· Material Acquisition or Purchasing

· Manufacturing

· Assembly

· Shipping


From the list of core processes we can then gather that the key part of the scope of the QMS will involve design, engineering and manufacturing. It is important to distill your scope statement and ensure it accurately representing your organizations activities.


ISO 9001:2015 also asks that we also consider internal and external issues as well as relevant interested parties when determining the scope. Issues both internal and external that are relevant to the organization may either positively and negatively affect the ability to achieve its goals. Interested parties also need to be factored in and relevant interested party need to be considered when the organization is formulating its scope of the QMS. The scope should be targeting those most relevant interested parties, namely its target market / customers.


If the target market for our example organization above is automotive and aerospace then this will need to be worked into the scope statement. For our example organization then we could develop as scope statement such as this:


Example Scope Statement: Design, development, manufacturing and assembly of products for the automotive and aerospace industries.


To further drill down the organization should consider the actual products and/or services provided to the end user covered by this scope. If this organization is in the business of designing, manufacturing, and assembly of cable harnesses for the automotive and aerospace industry then we can further refine the scope as:


Example Scope Statement: Design, development, manufacturing and assembly of cable harnesses for the automotive and aerospace industries.


At this point, this scope meets the intent of the ISO 9001:2015 Quality Management System Standard Clause 4.3. The next part of the requirement is to ensure that it is maintained as documented information in some form.


Lastly, it should be said that some organizations do not perform some activities covered by the ISO 9001 QMS Standard. In this case, the organization must define the exclusions to that particular section of the standard and provide justification for such exclusions.


If our example organization above did not perform design and development activities then section 8.3 of the ISO 9001:2015 QMS Standard pertaining to design would not be applicable and could then be excluded from the scope.


The revision scope then would read: Manufacturing and assembly of cable harnesses for the automotive and aerospace industries.


Exclusions: 8.3 Design and Development

Justification: The organization does not perform Design and Development activities.



If you are having trouble determining your QMS scope of certification contact us below to discuss. We would love to help you on your journey toward successful ISO 9001 certification!

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