The ISO 9001 Design Process Explained


Now that you’ve designed your product, you need to ascertain whether your process will be able to meet the requirements of the ISO certification in Qatar or not. High-quality design processes can be the lifeline of a manufacturing organization unless your company fabricates products based solely on the drawings provided by customers. If you take the requirements from other folks, you need to set up a product that’ll meet your requirements. After that, you’ll create your product for customers and engage in the design process at the same time. If you hope to achieve certification, your design activity has to meet specific requirements. The process you follow to meet them is entirely your preference.

The design process

Just like all the requirements of the certification, the standard never tells you what you should do for design implementation. It only tells you what you should include in the implementation. However, you shouldn’t fret over it. The best ISO 9001 consultants break everything down in this write-up into seven parts.

  1. Planning the design and development: In simple words, this section just describes that you need a plan on how you’ll take care of the designs. You have to keep things flowing smoothly while including people who’ll be in charge of establishing the steps. In doing so, you’ll ensure proper management of the handoffs between all the groups involved. Furthermore, the review steps should include checking the documents of the design output and updating them as and when required.
  2. The inputs: This one is the first step of the whole process. It ensures you accumulate all the necessary requirements for your design. Are you sure that you have all customer requirements mandated by industry or government regulations? You can discover them in older designs or somewhere else. The procedure has to determine these inputs, inspect them thoroughly for adequacy, and record the same.
  3. The outputs: These documents will define the design. They may contain everything you want to use for the defining purpose, including drawings, electronic machining files, written assembly guidelines, or any other medium you prefer. Just make sure the outputs have everything you included in the inputs.
  4. Reviewing: The process has to include review-related steps to ensure it works appropriately. You have to make sure the design will be able to meet necessary requirements, pinpoint all problems, and introduce the necessary changes. You must also include people from the areas of your company affected by your design.
  5. Verification: This one is almost always part of the design reviews in the process. Verification basically takes the design outputs to make sure it includes all the content present in the design inputs. For instance, if the inputs demand five different tests, you have to know whether the test procedure has the five tests with the appropriate pass/fail criteria or not.
  6. Validation: In this step, you’ll build the very first product and test the same to make sure it meets all requirements. It goes without saying that the product has to be usable too. It’ll take place whenever you want to, but you must do it before you deliver the product to customers or install the first unit for customers to use. Don’t forget to keep records of this venture.
  7. Controlling the changes: The final requirement incorporates making changes to the design process’s outputs. You can change the drawings, instructions, and everything else you need to convert the product design into an actual product. ISO 9001 consultants say that you have to make sure only the right person makes the necessary changes. It’s also worth mentioning here that you shouldn’t change anything without approval or implementation. You have to know how the changes will affect the related parts and usability.

Endnote

The objective of the design process is to seek out problems and prevent them. It’s the only way to ensure you obtain the ISO certification in Qatar.