The organization has established, implemented and maintains a design and development process that is appropriate for delivering its products and services. The nature, duration and complexity of the design and development activities need to be taken to account when defining the needed detail of the process.
The design and development process has a clearly defined owner and other related authorities.
The sequence of the design and development process includes at least:
- the definition phase for results to be achieved
- the required process stages, including applicable design and development reviews
- the required verification and validation activities (to confirm resulting products / services meet requirements)
- the internal and external resources needed
To control the design and development process, the following controls should be considered:
- the need to control interfaces between persons involved
- the need for involvement of customers and users
- the level of control expected by customers and other relevant interested parties
- the requirements for subsequent provision of products and services
- defining needed documented information to demonstrate that process has been followed
