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ISO9001 and Control of Design & Developments Process

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: 

  • Verification – Am I building the product right?
  • Validation – Am I building the right product?


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

​ a)       The results to be achieved are defined. Here it is about ensuring that controls are in place to make sure that the results of the design process are clearly defined, what are you trying to achieve here, for example if you are designing a car you probably want to ensure that you specify certain things before you start or you could wind up with a 2 door V10 sports rather than a 5 door family hatch that is electric.
​ b)       Reviews carried out to ensure the outputs of the design & development process meet the input requirements ​This is about meeting the design & development requirements that were specified in the previous planning stage, things such as regulatory and functional requirements would be factors here. It's important that this isn't a tick the box exercise, this is possibly the last chance to not build in unnecessary costs or miss key elements.
​ c)       Verification Activities are conducted to ensure the design & development outputs meet the input requirements. Activities here may include final sign off reviews, presentations to those who created the inputs for the process, product survey groups and so forth to ensure that what you have an in the design is what was asked for in the design brief.
​ d)       Validation activities are conducted to ensure that the resulting products and services meet the requirements for their intended use Here it is about carrying out the testing required to validate that your product will do what it says it should and is fit for purpose, it may be a rigorous level of testing through EMC chambers or vibration analysis or it may be a physical demonstration. The validation method used however must stand up to external scrutiny and industry practices.
​ e)       Problem areas addressed ​In this section you need to review the findings from the reviews, verification or validation sections and address any issues that have arisen to ensure that your product or service meets the original design and development requirements, only then should you move forward
f)       Documented information ​is available​Throughout the process a number of documents, specifications, findings, reports and so forth will have been created, these are your documented information. You must retain these for auditing purposes as part of the ISO9001:2015 requirements.

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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Monday, 20 May 2019

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