Guest user Created: Mar 21, 2018 Last commented: Mar 21, 2018

Design validation

"We manufacture standard product through a catalog with high customization adders. They are made to order applications. When standard product was originally designed, a full verification and validation process was performed. The ISO9001 auditor says I actually have no "validation" step. I cannot create a prototype for a one-time project. What is the implication of the "validation" in a make to order design and manufacturing?”

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Carlos Pereira da Cruz Mar 21, 2018

Answer:

Validation means the confirmation, with objective evidence, that the requirements for a specific intended use have been fulfilled. Can your company show, for example, the results of tests that demonstrate validation?

Another approach is to consider that your organization only performs a final verification to put the products on a catalog and that validation is done with the customer, after the customization and final customer approval. Normally, I use customer final approval as a sign of validation.

The following material will provide you information about design validation:

- ISO 9001 –
ISO9 001 Design Verification vs Design Validation
- https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Mar 21, 2018

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