Design and development
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This guidance has been superseded by ISO 9001:2015 Clause 8.3.4 Design and Development Controls. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.
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ISO 9001:2008: Design and development validation 7.3.6 (superseded)
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:
- Ensuring the product meets the specified requirements
- 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.
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