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Validation and verification

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Guest user Created:   Mar 28, 2016 Last commented:   Mar 28, 2016

Validation and verification

Is there any ISO 9001 documentation that can be used as a guide as to when to use Validation vs Verification? In our case we put on a new resin coating on a board. There were no hardware or software changes. Shouldn't Verification be sufficient?
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Strahinja Stojanovic Mar 28, 2016

Answer:

There is no specific ISO 9001 document or requirement that says in what cases you should use validation or verification. However, the definitions of those two terms provide a guideline on what should be used and when.

Verification is testing and measuring the product to determine whether it is compliant with product requirements.

Validation is used when the verification can not be conducted, it is the process of providing evidence that the final product is compliant with the initial product requirements. In your case, maybe it is impossible to measure entire surface covered with resin and verify that the resin coat has the same thickness on the entire surface so you need to establish process controls to ensure that the resin will be applied under same conditions on entire surface. This controls will basically represent the validation of your process.

For more information, see:
- ISO 9001 Design Verification vs Design Validation https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/

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Mar 28, 2016

Mar 28, 2016

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