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ISO9001 and Design and Development Outputs and Changes

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.

Requirements of the Design & Development Output Clause

  The aim of this section is to ensure that the outputs of the design process do a few things:

  1. That they meet the requirements that you set up in the design & development inputs (clause 8.3.3 discussed previously here)
  2. That they are adequate for subsequent processes. This could be the actual manufacturing process that will be required, for example there is no point designing something that you don't have the equipment to manufacture that you design something that needs to connect to another part but doesn't have the correct interface, ,packaging is another area that may be considered so it's important to think about this across the entire product or service scope.
  3. It is required to include or at least reference back to the monitoring & measuring requirement that you set up at the design input stage, for example, if there is a tolerance that must be met of a specific maintenance schedule that needs to be kept.
  4. The last requirement of this section is that the output must specify the characteristics for the intended use of the product and the safety requirements or limitations. This is one of those areas where you can end up with a list of things that you should not use the product for. I remember a plastic case for example that was warrantied for every eventuality under the sun except bears and 5-year-old children!
Again, this section is underwritten with the all-important SHALL work when it comes to keeping information on how you met this step which means you don't have a choice, you need to keep the information.

Design Changes 

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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Thursday, 02 April 2020

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