Clause 8 Operation
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.
This set of criteria requires an organization to document the expect outcomes of the design and development process, and review those outcomes or results against the specified requirements, relevant to intended use.
Where issues arise, how they are to be addressed should be done so formally, with good record-keeping to support actions taken. Changes to the design specification may be a result of associated verification and validation activities.
Methods of validation could include simulation techniques, proto-type build and evaluation, comparison to similar proven designs, beta testing, field evaluations, etc.