Content provided by Dan Nelson of Cavendish Scott (www.cavendishscott.com).

ISO 9001:2000 section 7.3.5 requires performance of design and development verification, while section 7.3.6 requires performance of design and development validation. A common question is, Whats the difference between verification and validation?

Both ensure design and development outputs meet respective input requirements. But how do they differ, and what is important about each?

Outputs are the Key

The difference between the two involves the outputs in question. Validation applies to a producta prototype or first article, for example. Validation ensures that a resulting product (or service) meets all input requirements applied to it. The question that is answered by validation is, Does the resulting product or service do what it was intended to do?

Conversely, the objective of verification is to determine if the design itself meets input requirements for the design phase at hand. The idea here is to ensure that the designas plannedis adequate before proceeding to subsequent design phases, and before actually committing materials or further effort to the design and development project. The question answered by verification is, Do design documents (e.g., blueprints, schematics, layouts, service plans) indicate fulfillment of respective input requirements? Or, Would a product made to these specifications perform as intended?

Once a design has been fully verified to meet input requirements, the designed product (or service) is created, and validated, to ensure the resulting product fulfills its intended purpose.

Designs Can be Complicated. The ISO 9001 Requirements are Clear