Mark Hammar Have you designed a product, but can’t figure out if your process meets the ISO 9001 requirements? As a manufacturing company a good design process is critical unless you only manufacture products based on customer drawings. If you are taking requirements from others, figuring out a product that will meet those requirements, and then creating the product for a customer, then you are engaging in a design process. To become certified to the ISO 9001 standard you will have to make sure your designing activity meets certain requirements, but how you meet them is up to you.
The Design Process
From the ISO requirements, a basic design process flow would go something like this:
The boxes are steps where action is taken in the design process, such as gathering the inputs or building the validation product. The diamonds are the review steps of the process where you are making a decision on the previous actions, and determining if it is acceptable to go forward with the design or if you need to continue the work. Review steps require records for reference later if something goes wrong. With the ISO 9001 standard, improvement of all processes is of utmost importance, so reviewing records when an error occurs, in order to find ways to improve the process, is a key way to implement process improvement.
The seven parts of the design process
Like all requirements in ISO 9001, the standard does not tell you how to implement the design process, but only what needs to be included in your implementation. The seven parts of the requirements tell you a few things that need to be included in your process to ensure a proper design. Below I will go through the seven sections of the ISO 9001 requirements and explain what the requirements call for in the design process.
Design and Development Planning. Simply put, this section just says you need to have a plan on how you do designs. All that may be needed is a flow similar to the one above, with the inclusion of who is responsible for the steps to ensure that handoffs between different groups are managed. Additionally, the review steps should check if changes are required to the design output documents, and update them if required… The requirements do not, however, require that this be a written process. Since this is not one of the six required documented processes you can decide if you need to write it out or not. The main deciding factor is if there could be errors due to the fact that the process is not written out.
Design Inputs. This is really the first step of the design process, and basically ensures that you make sure you gather all the requirements for your design. Do you have all requirements from the customer, mandated by government or industry regulation, discovered in previous designs, or anywhere else you find them? The process needs to determine these inputs, review them for adequacy and record them as part of the process.
Design and Development Outputs. These are the documents that define the design, and can be whatever you want to use to define it. This could be drawings, written assembly instructions, electronic machining files, or any other medium that you decide. However, the outputs need to include anything required in the inputs (if your customer requires a drawing, or your machine shop requires electronic CAD files), be usable by necessary departments such as purchasing and production, have the acceptance criteria for the product, and identify the essential characteristics for proper use.
Design and Development Review. Your process needs to include review steps to make sure that the process is working properly. Do you make sure that the design will meet the requirements, point out any problems, and make necessary changes? Do you include people from all areas of the company that are affected by the design, and do the reviewed results and actions need to be recorded?
Design and Development Verification. Verification is almost always one of the design reviews in a process. Verification is basically taking the design outputs (drawings, build instructions, test instructions, etc) and making sure that every requirement from the design inputs is included. If the inputs call for 5 tests, does the test procedure have all 5 tests with the correct pass/fail criteria? If government regulations say that the unit needs to be painted orange for safety reason, do the build instructions call for a step to paint orange? As always, records of the outcome are required.
Design and Development Validation. Validation is when you actually build the first product and test to make sure that it meets all the requirements, and intended use. There is a note that this should happen, whenever possible, before you ship or install the first unit for use by the customer. Again, records of this are to be kept.
Control of Design and Development Changes. The last set of requirements talks about changes to the outputs of the design process, or simply how you change your drawings, instructions, etc. that tell you how you turn your design into a product. The idea is to make sure that not just anyone can make changes without making sure that the change is shown to be good and approved to implement. Included in this is deciding how making this change will affect related parts, and how not making this change to parts already complete will affect their usability. Of course, records of these changes need to be kept.
The Design Process – the first step in preventing problems
It is important to ensure that the design process focuses on having proper reviews so that potential problems with manufacture are caught and eliminated early. It has been said that problems caught in manufacturing are at least 10 times the cost to correct as those caught in design. With this in mind, a well-executed design/review cycle can save time and money by eliminating problems before they occur.
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