ISO 9001:2015 Clause 8.3.6, titled "Design and Development Changes," specifies the requirements for controlling changes made during the design and development process. This clause emphasizes the importance of identifying, reviewing, and controlling changes to prevent unintended consequences. Key elements include:
- Identification of Changes: Changes to the design and development process must be identified. This could involve changes in design specifications, materials, or methods.
- Review of Changes: Before implementation, changes must be reviewed to assess their impact on the product or service and the overall design and development process. This review should consider the effect on constituent parts and the product or service as a whole.
- Control and Implementation: Changes must be controlled and implemented. This involves updating documentation, informing relevant personnel, and ensuring that the changes are carried out as intended.
- Records of Changes: The organization must maintain records of design and development changes. These records should document the results of reviews, the authorization of changes, and any necessary actions arising from the review.
The purpose of Clause 8.3.6 is to ensure that any changes to the design and development process are made in a controlled manner, thereby maintaining the integrity and performance of the product or service. This clause helps organizations manage change effectively, ensuring that alterations do not adversely affect product quality or compliance with requirements.