What You Need To Know About Outsourced Processes
The ISO 9001 Quality standard allows for non-applicable areas of the standard to be removed and therefore not included within the audit. You have to justify these non-applicable areas which means that you can’t exclude something you do and likewise you can’t include something you don’t. If something is within the scope then we need to be able to assess that area during the audit so be careful not to include future plans.
The most common failure with organizations when identifying their scope is claims that areas of the management system which they do not perform in-house can be excluded, this is not the case! These are known as 'outsourced processes' and cannot be excluded from the management system, you are ultimately responsible for these areas whether you perform them internally or they are contracted out.
The two main areas which organizations try to claim are not applicable are design and special processes.
Design and Development
If your organization is selling anything which has been designed either by internal staff or you have engaged the services of an outside contractor then you must have this included within your scope, you also need to be able to demonstrate control over this function. You will be audited to the design clauses of the standard so you need to ensure you have appropriate records regardless of who the task is performed by.
Tooling can be a confusing part of design for some organizations, they assume that tooling design is not included in the system as you are not designing a product. You are designing a product, the product is the tool not an end component. The exception to this would be if the tooling is to be used for internal purposes only and is not a sellable item, this can usually be some jigs and fixtures. Always ask yourself who owns the tool, can the customer take the tool and go elsewhere? Has the customer paid for the tool? In these cases design must be included within your management system.
Special processes are processes which cannot be measured 100% to ensure they meet requirements. These are commonly painting, anodising, heat treatment, welding etc. You need to control these processes to ensure consistency of the end results. A lot of organizations will not perform these in-house and will contract these out to specialist third parties. Its important to note that you still have to include these within your management system as you are responsible for them.
In order to maintain responsibility ensure that you receive sufficient documentation from the supplier of these processes to ensure that they meet requirements. For example, what records do you retain to demonstrate that the hardness of the metal has been achieved? The paint thickness is correct? Etc.
Just because something is outsourced, doesn’t mean you are not responsible for it and don’t need to include it within your management system. Ensure that you meet the requirements of the relevant outsourced processes and can demonstrate to an auditor that you have sufficient control and evidence to satisfy the requirements of the standard.
Author: Michael Venner, NQA's Aerospace and Automotive Director