Mark Hammar With the updated Quality Management System (QMS) requirements in ISO 9001:2015, there have been some minor, yet important changes in the requirements for design and development activities within the Quality Management System. In the past, many companies have taken the opportunity to exclude the design and development activities required by ISO 9001 under the claim that they did not design products for the customer.
This was particularly true of companies in the machining industry, which would take the drawings designed by their customers and simply perform the machining required to meet the customer design; in effect, they could claim that they did not design the product themselves. While it is still possible that some companies may be able to make this claim, this may become more difficult with the change in ISO 9001:2015.
What has changed in ISO 9001:2015?
While the design and development process outlined in ISO 9001:2015 is still the same as in the previous version of ISO 9001, the one change that has been made is the applicability of design and development to products and services of the company. Even though in ISO 9001:2008, design and development was applicable to companies that provided services as a product, it was not specific about all of the services of all companies.
Now that the requirements are worded as “applicable to your company’s products and services,” you will need to look further than just developing new products. You will need to ask if you design new products in terms of new development or in response to your customer orders, but also if you design new services in terms of new development or in response to customer orders.
So, if you are looking to offer a new service to your customers, such as a service to review their design documents before machining, you will then need to follow the design and development process outlined in ISO 9001:2015 to design this new service.
For a better understanding of the design process in ISO 9001, see this article on The ISO 9001 Design Process Explained.
How can this change affect machining companies?
As has been stated, in the past it was easy for a machining company to make the statement that they only took a customer design and manufactured it, but you will need to be more discerning about what constitutes design of a product or service.
Specifically, for the machining industry the following activities could be considered a design activity, and therefore require that the design process outlined in ISO 9001:2015 be followed:
- If you take customer specifications and create the drawing and CNC programming, then you are doing product design activities.
- If you take a customer drawing and create the CNC machine programming to create this part on your machine, then you are performing design activities.
- If you are developing new services, such as the drawing review service stated above, then you will need to follow the design process to create this service.
- If you are changing the services you provide to your customers, such as how you conduct the review of their drawings or the delivery service you provide, then you will need to observe the design change processes in ISO 9001:2015.
Therefore, if you are simply taking the CNC program information for your customers to machine the parts they want, and keep the same services that you already have in place, you could claim that design and development is not applicable to your organization. However, it may very well be that some of the activities you did not consider to be design and development before will now fall under these requirements.
The design and development process: Not that scary
As you can see in the article linked above, the actual design and development process that is outlined in ISO 9001 is not as onerous and cumbersome as many people think. In general, you need to identify your design inputs (or requirements) and create the design outputs (the documents and drawings you need) for the product or service you are designing. You then need to verify that all of the requirements in the inputs are addressed in the outputs, and validate that the product or service actually meets the requirements when created. The last thing you need to do is to control any changes in the design of the products and services you supply to your customers.
When you consider a simple flow for the design and development process as detailed above, the process can be very beneficial to your company, because the key point is to make sure that you do not miss any requirements and that you keep control over changes to your products and services. In the long run, this can help you to improve the products and services you provide to your customers, and because continual improvement of your QMS is a key reason for implementing ISO 9001:2015, this can only make your company better.
To find out more about design and development in ISO 9001:2015, along with all of the other requirements, take this free online training ISO 9001:2015 Foundations Course.
