Design and development activities needed for products and services are required to be planned and controlled through an established, implemented, and maintained process. This process may be used for both products and services and for associated processes. It is required to include the following:
1) Planning to determine design stages considering activities such as verification and validation, control of design interfaces, design review, resources needed for design and development, customer involvement, and the documented information needed to confirm that input requirements are met.
2) Determination of the design and development inputs required, including such things as functional requirements, regulatory and statutory requirements, applicable standards or codes, information from earlier projects, and potential consequences of failure. Conflicting requirements are required to be resolved.
3) Design and development controls, including clear delineation of the results to be achieved, planning and conducting design and development reviews and verification activities to ensure design outputs meet input requirements, and validation to ensure the products and services meet the requirement for the application intended.
4) Design and development outputs are required to meet input requirements, to be adequate for subsequent processes in the provision of the product or service, and to ensure the products and services are fit for their intended purpose.
5) Design and development changes are required to be identified, reviewed, and controlled. This includes changes to design inputs or outputs. Controls are required to ensure that changes do not have an impact on the products and service conformity
6) The organization is required to retain documented information resulting from the design and development process, including design and development changes
The key reason for this emphasis on planning is to maximize the probability that the project will meet the defined requirements. If the design and development processes are well planned and controlled, an additional benefit should be that projects are completed on time and within budget, Planning is required at the level of detail needed to achieve the design and development objectives—not to generate an excessive amount of paperwork.