Guidance

Design and development

The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Design and development verification 7.3.5

Design verification basically means that the product can be produced as designed and that the output meets the intended input requirements. Additionally it should show that the organization has the capability to produce the product with existing equipment and has the personnel competencies or has the ability to train or subcontract the required capabilities. The basic concept is 'does it work on paper?'

Verification is a comparison between the outputs the inputs. Does the available evidence indicate that the design will meet the requirements? The verification could consist of calculations, simulations, prototype evaluation, tests or comparison against samples.

You must maintain records of design verification as these records will indicate the results of verifications and determine any necessary corrective actions. Perform design and development verification by determining:

  1. Whether the outputs meet the input requirements for the design
  2. The types of records that are required