This step manages the process of designing and developing products or services stage by stage. As results, you receive a design and development plan and design change control records.
It plans design and development by stage and determines the inputs (requirements). After review, verification and validation, the outputs (design results) are approved, and any design changes are controlled.
A company that does no design and development states the justification for excluding it from the scope (the reason the exclusion is acceptable).
Note: the number beside the title is the basis clause. HS is the Harmonized Structure (the common clause layout used across ISO standards).
Output
- Design and development plan: Stage / Activity / Deliverable / Review, verification and validation / Responsibility / Schedule
- List of design inputs and outputs and a template for review meeting minutes
- Design change control records
Next steps
Economic Prosperity: Preceding steps: Legal Requirements Identification · Risk Assessment · Contract Management
Steps that use the results of this step: Supplier Management · Process Control
When operating, designate the Management System\Design and Development Control folder (or files), and eiso will organize, aggregate, analyze and synthesize that material.
Material to designate: design plans, review, verification and validation records, design change records. (Management System Operation Guide)
