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What Does ISO 9001 Clause 8.3.6 Design and Development changes Mean?

ISO 9001 Clause 8.3.6 addresses the controlled management of changes made during the design and development phase in order to reduce the possibility of unfavorable effects on the finished good or service. Often time a design change can impact purchasing (change in materials or material specification), production (drawings, work instructions, or testing), shipping (change in packaging), or quality (change in testing). Therefore, it is important to ensure that everyone is literally on the same design revision at all time.

ISO 9001 Clause 8.3.6 - Design and Development Changes

This clause emphasizes the need for a structured approach to identify, review, and control changes made during or after the design and development of products and services. The key elements are:

1. Identification of Changes: The organization must have a system in place to identify changes in the design and development phase. This includes modifications made during or after the initial design process.

2. Review of Changes: Changes must be systematically reviewed to assess their impact. The organization needs to evaluate whether these changes adversely affect the conformity to requirements. This involves a comprehensive examination of the potential consequences.

3. Control of Changes: The organization must implement controls to manage the changes effectively. This could involve obtaining approvals, updating relevant documentation, and ensuring that the changes are applied consistently across the organization.

4. Documented Information: The organization is required to maintain documented information related to design and development changes. This includes:

  1. Details of the changes themselves.

  2. The outcomes of the reviews conducted.

  3. Authorization records for the changes.

  4. Actions taken to prevent adverse impacts.

Example of Clause 8.3.6

Imagine a software development project where a change is proposed to the user interface of the application after the initial design has been completed. The organization would need to identify this change, conduct a review to understand its impact on user experience and functionality, control the implementation of the change, and document the entire process. This ensures that the alteration doesn't negatively affect the quality and conformity of the software.

Change Identification: In a software development project, the initial design phase has been completed, and the team is working on coding based on that design. During a team meeting, a developer proposes a change to the database schema to enhance the performance of the application.

Review of Changes: The proposed change triggers a review process. The development team, along with the project manager, assesses the impact of this change on the overall system. They consider factors such as potential improvements in performance, compatibility with existing modules, and any potential risks or drawbacks.

Control of Changes: Upon determining that the change is beneficial and won't adversely affect other parts of the system, the team decides to proceed. The change is documented, and necessary approvals are obtained from the project manager and other relevant stakeholders. The version control system is updated, ensuring that everyone working on the project is using the latest design specifications.

Documented Information: The organization maintains documentation of this change. This includes records of the initial proposal, the review process, approvals obtained, and the updated design specifications. This information is stored in a centralized repository accessible to relevant team members and can be referred to in the future for auditing or knowledge transfer purposes.

In summary, Clause 8.3.6 ensures that changes in the design and development phase are not haphazard but rather a controlled process that considers potential impacts and involves proper documentation and authorization.

ISO 9001:2015 Clause 8.3.6 Design and Development Changes

ISO 9001:2015 Clause 8.3.6 Design and development changes is about managing modifications to the design and development phase in a controlled manner, minimizing the risk of adverse impacts on the final product or service.


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