John Nolan The requirements of design and development are fairly prescriptive within the ISO 9001:2015 standard in terms of planning, inputs, outputs, controls, and changes to this process. For many organizations manufacturing standard products with little change, this is a vital and often straight-forward clause to follow, but when design and development requirements change constantly – like in the technology sector – this clause takes on even greater significance. So, why does this happen, and how can we use the advice given in ISO 9001:2015 to ensure that we control our design and development process effectively, thereby creating a consistent product?
Design & development clause: Why does it matter?
Many technology companies work according to different plans from other sectors when developing products. It is often the case that a combination of customer requirements, market forces, and the organization’s own sense of invention can combine to provide the inputs to this process, unlike other sectors where this process is normally driven by customer requirements alone. For example, a customer may specify to the organization that it requires a special computer interface with two USB ports, but during development the team realizes that it is possible to incorporate four USB connections, thereby expanding the potential market that is available to the product. In theory, this will require some sort of approval from the customer, unless the “4 port” project is to be run separately, which usually will incur extra costs. If agreed to by the customer, the inputs and outputs of the originally agreed project will have changed, so what within ISO 9001:2015 can help us control this process?
Design & development: How to control it?
Given the circumstances above, controlling the organization’s design and development process now becomes ever more critical. Planning is one of the most critical elements of any design and development process, but given that the inputs are likely to change, what other elements must we carefully consider? Let us look more closely:
- Ensure that your inputs are approved and documented: In the previous article: ISO 9001 Design verification vs. Design validation, we looked at verification and validation. It is important to understand these and how they translate to your process; this understanding can be the foundation for ensuring the inputs and requirements for your design process are agreed upon, signed off on by the correct stakeholders if required, and version controlled to ensure that each member of the team is working according to exactly the same requirements.
- Review constantly and effectively: This is particularly important in a design process where changes may occur regularly. Reviewing, ensuring stakeholders agree and approve, and documenting accurately are again important, as is the vital element of communication – it is critical that all people in the design and development phase are part of an accurate communication loop, or your product will suffer from “project creep,” and the need to rework a product that has gone off track is always expensive in terms of time, resources, and materials.
- Ensure that your testing phase is effective: A product that does not function correctly will not meet customer needs. Ensure that your testing phase is fully considered, and that lessons are learned from your past testing, market expectations, and customer requirements. This testing, in line with your cataloging of customer specifications in the test phase, can prove to be a vital part of your product “validation” process.
- Ensure that you have an effective mechanism to track changes: Previously, in the article: Using the ISO 9001 Change Log to ensure customer satisfaction, we looked at the positives of using a Change Log in your process. This not only gives you and your team a time-specific picture of what happened – and when – within your design and development process, but it can also help you build an accurate history of a product, which can help you learn lessons for your next project. Also, if you have employees involved in a project who have vacations or absences, catching up on the changes to a project is easily done with this document.
Delivering quality products in times of change
Adapting to changing demands and markets is one of the major challenges for all organizations these days, but especially those in the fast-moving technology sector. If your organization is to survive and prosper, then it will need to pay careful attention to the varying factors that may put pressure on your design and development process, and act accordingly. A well-planned, administrated, and communicated process can ensure accurate and consistent product delivery, and conversely, the opposite will result in poor product that fails to meet customer and market expectations. Make sure you use the ISO 9001:2015 principles to deliver your product successfully.
Why not use our free online training ISO 9001 Foundations course to learn about design and development requirements?
