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Design and nonconformities

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Guest user Created:   Jun 28, 2018 Last commented:   Jun 28, 2018

Design and nonconformities

"(1) I was just wondering if for example, we are currently on the first article inspection of the product and after the design and product, the customer deemed that he wants to have it modified or changed since it does not meet requirements. Will that be counted as nonconformance for ISO 9001? (2) Also, for cases where we design and develop certain products and during the development, we found out that the product will not be useable and therefore, another stage of parallel development must be conducted. Will that be considered a nonconformance in the design?"
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Carlos Pereira da Cruz Jun 28, 2018

Answer:

(1) – Who established the product requirements? Why did the customer asked for modifications? If the customer established the initial specifications and:

* now he is asking changes because those specifications were not met, that is a non-conformity;

* now he is asking changes because although the specifications were met, they are not useful during use, that is not a non-conformity.

If the initial specifications were developed by your company and were met, and t he customer is asking for changes, that is not a non-conformity about the product. Perhaps, your company could consider a non-conformity of the service: you want to improve future collection of input information for project development (not may companies follow this way)

(2) – I do not consider this situation as a non-conformity in the design. There is no agreed specification yet, many times this is a trial and error phase.

The following material will provide you information about design and development:

- ISO 9001 - The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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Jun 28, 2018

Jun 28, 2018

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