When you are identifying the context of your organization and scope of the QMS, it is critical for your business to be aware of what should and should not be included within the scope.
The AS9100 QMS standard allows organizations to decide what areas within the standard are non-applicable and can be removed. It is required by the standard that areas you deem non-applicable must be justified. You are not allowed to exclude something your organization does or include something you don’t. Sections of the standard that are non-applicable will not be included within the certification audit.
One of the most common failures auditors (registrars) find is that organizations exclude areas of the management system which they do not perform in-house. This is a common misconception. Outsourced processes must be included in the QMS. Your organization is responsible for them regardless of whether you perform them internally or if they are contracted out.
The most common areas within outsourced processes that organizations do not claim within their scope are design and development, and special processes.
Design and Development
Design and Development must be included within your scope whether it is performed by internal staff or if you have an outside contractor performing this task. Your organization will be audited (learn more about audit types and how they are executed) to the design requirements of the standard for your internal and outsourced design processes.
Tooling is also another common nonconformity because it is usually not included within your quality management system scope. Organizations believe tooling should not be included in the systems because you are not designing a product. But in fact, you are designing a product, the product is a tool and not an end component. The one exception to this rule is if the tooling is used for internal processes only and is not a sellable item. When you are deciding if the tool should be included, ask yourself: Who owns the tool? Can the customer take the tool and go somewhere? Was the tool purchased by a customer? If the answer is yes to any of those questions, the design must be included within the QMS.
Special processes are processes which cannot be measured 100% to ensure they meet requirements. These processes usually include things like welding, heat treatment, painting, etc. These special processes need to be controlled in order to ensure consistency of the end result. Most of these processes are not performed in-house and are contracted out. These types of processes still need to be included within the QMS.
As most of these special processes are contracted out to third parties, it is imperative that you receive sufficient documentation to ensure that they meet requirements. For example, if something is coated with Teflon, you must demonstrate that the properties of a Teflon coating have been achieved. Or if something is painted, the paint coat was properly applied, and the thickness is correct.
Overall, it is important to remember that just because something is outsourced, doesn’t mean you are not responsible for it and do not need to include it within your QMS scope. When you are implementing AS9100 into your organization, you need to ensure that you meet the requirements of the relevant outsourced processes. During the audit you must demonstrate to the auditor that you have sufficient control and evidence to satisfy the requirements of the standard.