8.3 Design and development of products and services (8.3.4)

8. OPERATION

8.3 Design and development of products and services

8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

• a) the results to be achieved are defined;
• b) reviews are conducted to evaluate the ability of the results of design and development to meet requirements;
• c) verification activities are conducted to ensure that the design and development outputs meet the input requirements;
• d) validation  activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
• e) any necessary actions are taken on problems determined during the reviews, or verification and validation  activities;
• f) documented information of these activities is retained.

NOTE Design and development reviews, verification and validation  have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization.