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ISO9001:2015 clause 8.3.5 Design and Development Outputs can sometimes cause confusion on it's purpose. It is not about the actual product that is being designed but about the outcome of the design process, a design drawing or CAD model for example.
The aim of this section is to ensure that the outputs of the design process do a few things:
Clause 8.3.6 Design & Development Changes of ISO9001:2015 requires that an organisation review changes before implementing them to ensure that they don't have unintended consequences to the performance of the product with respect to the design requirements which would also typically include safety.
Any changes that you decide to make, or not make, should be fully documented and that information must be retained for future reference. It's not quite as simple however as writing down what you are changing, the change needs to be properly reviewed and finally authorised by someone who has both the authority and the knowledge to ensure that the change will do what you expect and will not impact the functionality of the product or service with respect to the design requirements.
As part of the design change there needs to be consideration given to the need to retest and re-verify the product with respect to standards for example if drop tests were done to prove the product robustness then you need to consider if these now need to be redone because of this change, again documenting the results of these tests to show that no negative results occur because of the design change.
For both Clause 8.3.5 Design and Development Outputs and 8.3.6 Design and Development Changes of ISO9001:2015 the key element is proving, documenting and retaining. In order to prove that the output of the design process meets the inputs and that any changes you subsequently make to the design documentation you must have it fully recorded and available for scrutiny by anyone who requests it.
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