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Think about clause 8.3.4 Design and Development Controls within ISO9001:2015 as the Check section of the Plan Do Check Act (PDCA) loop.
In earlier clauses of section 8.3 – (Design & Development of Products & Services) the organisation was required to carry out some detailed design & development planning and to look at the assorted inputs to the design process, section 8.3.4 then is for you to review the design and verify and validate that the design does what you need it to do.
It's sometimes easy to get confused about what validation is and what verification is, think of it simply with these questions:
The organisation needs to meet a few elements as part of this section, again it's a SHALL so you don't have a choice in terms carrying out the steps, you do of course have unlimited choice on how you go about meeting these steps
From an ISO9001:2015 point of view, the process itself doesn't actually have to be documented but as we have said many times before it would be entirely sensible to document how you will carry out the requirements of this clause and demonstrate how you do this repeatably over time
ISO9001:2015 Clause 8.3.4 of Design and Development Controls is about ensuring that you have the required process steps in place to ensure that you are both making the product that you think you are making but also that it is fit for purpose when you do make it. This means you will need to think carefully about what you do and plan these controls carefully at the start of the process and include them in the design thinking and costings of your product or service as they can quickly add up. ensuring that these steps are carried out and fully documented is critical to your quality management system and you should take whatever measures you need to ensure that you don't step key steps int he process, the results could be products you can't sell.
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