ISO 9001:2015 – Determining the Scope of the Quality Management System

Scope statement examples for ISO 9001:2015

ISO 9001:2015 requires an organization to determine the boundaries and applicability of its quality management system (QMS). This determination lays the framework for establishing the organization’s scope, which is then required by ISO 9001 to be maintained as documented information.
 
When determine an organization’s scope, ISO 9001:2015 (4.3) requires that consideration must be given to:
 
1.       the internal and external factors referred to in 4.1;
2.       the requirements of relevant interested parties referred to in 4.2;
3.       the Products and Services of the organization.
 
What does this mean? The following are a few examples of scope statements, in this case detailing a fictitious company (XYZ) that provides machine shop services. While the XYZ company is fictional, these are actual examples of scope statements we’ve encountered, just slightly edited for illustrative purposes and to make this example:
 
Machine Shop Example #1 (Worst Example): “We are a machine shop.”
 
Commentary: required items #1 and #2 in ISO 9001 (4.3) are not addressed, and item #3 could be much, much better described with regards to the products and services the organization provides.
 
Machine Shop Example #2 (Slightly Less-Worse Example): “We are an industry-leading provider of machine shop services.”
 
Commentary: required items #1, #2 in ISO 9001 (4.3) are still not addressed, and item #3 could still be much better defined. Stating the you are an “industry leading provider” is not scope-related, and these types of adjectives and adverbs should be saved for marketing materials.  At this point, you’re trying to explain the boundaries and applicability of the management system, not position yourself to make a sale.
 
Machine Shop Example #3 (Slightly Better Example): “Company XYZ specializes in the precision machining of components for use in the automotive industry.”
 
Commentary: This statement is somewhat better than previous examples. This version of the scope statement covers the products and services of the organization and refers to, albeit in a very limited manner, the relevant interested parties and their requirements.
 
Machine Shop Example #4 (Even Better Example): “Located in Houston TX, Company XYZ is a high-volume machine shop that specializes in the precision machining of aftermarket aluminum brake, steering and suspension components, in accordance with OEM specifications and government regulations, for use in the automotive industry.”
 
Commentary: Now we’re starting to make some real progress. There is still more polishing to be done, but now this statement is coming closer to addressing all requirements. It likely won’t be possible to address every internal and external factor, every interested party and every product in your scope statement, but at least an attempt should be made to summarize these different considerations.
 
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When creating your scope statement, bear in mind that this requirement of ISO 9001:2015 requires you to define the scope of your quality management system, not the scope of your ISO 9001 certification. ISO 9001 certificates also have their own scope statement, which is determined along with your certifying body, if one is used.
 
Note again, the scope of the quality management system is required by ISO 9001:2015 to be maintained as documented information. It is one of three requirements prescribed by the standard (scope, quality objectives, and quality policy), whereas most other requirements to maintain documented information are “as necessary”. Also, keep in mind that per ISO 9001, this information must also be made available to interested parties.
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