The design and development of a product or service constitutes a real creative process. It starts from an idea, a problem or a specific need and produces a solution in the form of a conceptual model or a detailed specification that can be used to create a fully functioning product or service.
Design and development, however, precisely because of their very nature, are a real journey into the unknown that can have the purpose of setting new levels of performance, establishing new standards, or giving feedback to new desires that have arisen in customers and, in such a journey, organizations may encounter obstacles that they have not foreseen and that may lead them to change direction even if their final objective must remain constant, having been previously established by the verified adherence to the requirements relating to products and services contained in the ISO 9001:2015 standard.
Design and development are a set of processes capable of transforming generic desires relating to an object or a potential service into detailed requirements. There is, however, a great difference between the "design" and "development" phases, even though these two terms are often incorrectly used as if they were synonyms.
Design is the phase during which, through a creative process, a designer tries to understand and interpret the needs of a customer and creates a concept. The developer, in the next phase, translates this concept into real technical specifications.
We can, therefore, say that design is a creative phase while development is a constructive phase. Trying to critically reread the history of the evolution of ISO 9001, we see that in the 1994 version the requirements were expressed in terms applicable only to products and not to services and that it was based on the premise that design could be controlled by adherence to documented procedures.
All this changed in the 2000 version when it was required for the first time that the processes relating to design and development were planned and documented.
During the ISO 9001 updates, another twelve requirements were added containing more details regarding what must be included in the design inputs and the reasons why design reviews should be conducted.
The basic structure of the requirements of this part of the standard has remained practically the same, but the number of design and development requirements, starting from 1987, has almost doubled. Managing a design and development process implies keeping the project on the right track and leading it towards its objectives, addressing, little by little, all the factors that could prevent the expected result from being achieved.
Once this process has been planned and implemented in organizations that do not continuously design new products and services, the event may not occur again for a long time because the process would only need to be maintained over time until the project has been completed.
Once the project has been completed, it will cease to exist until it is activated again. This means that a new process must be established for each new product or service and also for each product or service that is modified over time.
Of course, a generic model of the design and development process can be adapted for each new similar product or service project. What we must be sure of is to control the process through which products or services are created or modified, so that the resulting design can truly reflect the real needs of the customer.
This work can be done by controlling the inputs and the selection of the elements to be used in the design (such as components and technologies) and by controlling the outputs. Without the control of the design and development process, the following possibilities could occur:
- the design could start without having established clear and agreed requirements between the parties;
- costs could increase as designers look for solutions that go beyond what the customer really needs;
- costs could increase as suggestions are incorporated into the project without due consideration of the impact on development times and costs;
- projects could be released without adequate verification and serious validation;
- projects could be expressed in terms that cannot be economically implemented in production or service delivery;
- finally, the larger the project, the greater the risk of exceeding the budget and the estimated time for its implementation.