An organization must establish, implement, and maintain a controlled and systematic process to implement clause 8.3 of ISO 9001:2015, which focuses on the design and development of products and services. This process should include:

- defining design and development stages,

- determining review, verification, and validation responsibilities,

- and managing changes during the design and development process.

It requires understanding customer requirements, ensuring legal and regulatory compliance, considering subsequent stages of the product lifecycle, and documenting all design and development stages. The aim is to ensure that products or services meet customer and applicable statutory and regulatory requirements.