Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

(From BS EN ISO 9001:2000)

Following up on the verifications done on various parts of the product, this clause intends to look at the whole picture of the product and its processes—this is an important distinction to understand, because it differs from Sub-clause 7.3.5 and verification.

Design validation ensures the design (as evidenced by the product or service) meets requirements for the specified application or intended use. This can sometimes be completed during final test, or it may require validation in the customer-operating environment, e.g., field test, beta test, acceptance test.

For example, if an organization is a manufacturer of all-terrain vehicles and the military ordered a new fleet, they may have specific requirements that need to be tested in the field. Specifications such as bomb-blast resistance, suspension and storage space for military equipment would be much different than if the vehicle is intended for the suburbs of Los Angeles. These issues should be validated before delivery, and the only way to do that is by testing the product in the field.

This step in the process also is critical to other sectors as well, including software, aerospace and even service organizations. Once the product or service passes the validation stage, only then should it go into production for the customer.