ISO 9001:2015 Clause 8.3.4, titled "Design and Development Controls," specifies the measures that organizations must implement to control the design and development process of products and services. This clause emphasizes ensuring that the design and development process:
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Is Conducted in a Controlled Manner: Organizations must apply controls to the design and development process to ensure that results meet requirements. This involves applying systematic measures to control the design and development stages, ensuring that outputs meet input requirements.
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Involves Reviews: Design and development reviews must be conducted at planned stages to evaluate the ability of the results of design and development to meet requirements. Reviews are intended to identify any problems and propose necessary actions early in the process.
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Includes Verification and Validation: Verification must be performed to ensure that the design and development outputs have met the design and development input requirements. Validation ensures that the final products or services are capable of meeting the requirements for the specified application or intended use, where known.
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Handles Changes Appropriately: Design and development changes must be identified, reviewed, and controlled. Changes can impact the final product or service, and as such, they need to be managed carefully to prevent adverse effects.
The purpose of Clause 8.3.4 is to ensure that the products and services designed and developed by an organization are fit for their purpose and meet both the requirements specified in the design and development inputs and customer needs and expectations. This process helps to mitigate risks and errors in the design and development phase, contributing to overall product and service quality.