Design Change Procedure ISO 9001 2015 | QP1110

ISO Design Change Procedure

The ISO Design Change Procedure outlines the procedure for requesting changes to your company products or processes and implementing those changes, to assure orderly, controlled, and effective changes to every aspect of the design of your company products in conformance with ISO 9001:2015.

This procedure applies to all of your company’s design processes and to all products designed by your company; specifically, to change control. (8 pages, 1156 words)

Design change requests often come from existing customers as a result of complaints, new capabilities, or requirements. Such requests may also originate within the company (e.g., responding to news of a competitive product, production issues, supply issues, preventive actions).

ISO Design Change Responsibilities

Design Engineers are responsible for ensuring that all product design changes are recorded, communicated, and implemented; the department is also responsible for evaluating change requests and determining appropriate responses.

Document Control or an individual designated by Management is responsible for assuring that obsolete/superseded documents are removed from the work environment and only current revisions of necessary documents are available at point of use.

ISO Design Change Procedure Activities

• Requesting Design Changes
• Engineering Change Notice
• Change Design and Development, Review, Verification, Validation and Testing
• Preproduction Planning and Manufacturing

ISO Design Change Procedure References

• ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sep., 2015.
• Quality Procedures

ISO Design Change Procedure Forms

• Engineering Change Notice Form