ISO 9001:2015 Clause 8.3.2, titled "Design and Development Planning," specifies the requirements for planning design and development activities. This clause emphasizes the importance of determining the stages and controls for design and development, considering the nature, complexity, and timelines of the activities. It requires organizations to:
- Define the design and development stages.
- Determine the review, verification, and validation that are appropriate to each stage.
- Identify the roles and responsibilities involved in the design and development process.
- Consider the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibilities.
- Manage changes during the design and development process, evaluating the effects on constituent parts and the whole of the product or service.
The objective of Clause 8.3.2 is to ensure that design and development activities are conducted systematically and manageably, with appropriate oversight at each stage, to result in products or services that meet requirements.