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 validation 7.3.6

Validation is similar to verification, except this time you should check the designed product under conditions of actual use. If you are designing cars, you might take your creation for a spin on the test track or if you are making fizzy drinks, you might conduct a consumer taste test. The basic concept is 'does it work in reality?'

Verification is a documentary review; while validation is a real world test. Perform design and development validation by:

  1. Ensuring the product meets the specified requirements
  2. Maintaining records

The organization shall have records that the product designed will meet defined user needs prior to delivery of the product to the customer, as appropriate.

Methods of validation could include simulation techniques, proto-type build and evaluation, comparison to similar proven designs, beta testing, field evaluations, etc.

Irrespective of the methods used, the validation activity should be planned, executed with records maintained as defined in the planning activity.