ABSTRACT
The standard requires design and development verification to be performed in accordance with planned arrangements to ensure the output meets the design and development inputs.
ISO 9000 defines verification as confirmation, through the provision of objective evidence that specified requirements have been fulfilled. There are two types of verification, those verification activities performed during design and on the component parts to verify conformance to specification and those verification activities performed on the completed design to verify performance against the design input. When designing a system there should be design requirements for each subsystem, each item of equipment and each unit and so on down to component and raw material level. Each of these design requirements represents acceptance criteria for verifying the design output of each stage. Verification may take the form of a document review, laboratory tests, alternative calculations, similarity analyses or tests and demonstrations on representative samples, prototypes etc. In all these cases the purpose is to prove that the design is right, i.e. it meets the requirements. Validation on the other hand serves to confirm that it is the right design, i.e. that the requirements were the right requirements for a specific application.
