Design and Development Changes - Clause 8.3.6 of ISO 9001/AS9100 Standard
Last up in our blog series of clause 8.3 of the ISO 9001/AS9100D standard: 8.3.6 – Design and Development changes. This section applies to an organization that changes a pre-existing design. This clause necessitates a review, verification, and validation of design changes done by an organization. Design changes, in other words, must go through the complete design process.
This clause of the ISO 9001/AS9100D standard specifically states what documented information and records must be retained related to design changes.
What needs to be documented?
Design and development changes
What is being changed and why? When will the change be implemented? Describe the changes in the design in detail, and give some context for the design change. This would be a good place to keep track of the design change’s timeline and milestones.
Results of reviews
Design changes, like all designs, must go through at least one review. The organization should consider having documentation that can answer questions such as:
- Who were the participants?
- When did the review take place?
- What issues were discussed?
- What actions will be taken?
Authorization of changes
If an organization decides to change their design, the idea must have been proposed and authorized. This clause of the standard aims to understand who authorized the change and when. It is also important to include justification to explain why the design is being changed.
Actions taken to prevent adverse impacts
Change, in general, has ripple effects that influence other elements of a system. The same is true for an organization changing its design; anything related to the design will be affected. The standard requires the organization to document in considerable detail what it is doing to avoid adverse effects from the design change.
Overall, this final clause of section 8.3 of the ISO 9001/AS9100D standard aims to ensure that records exist to document the complete design change process, including reviews, justification, authorization, and preventative actions.