Management system guidance
8.3 Design and development of products and services
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8.3.1 Design and development - General
This requirement mandates the introduction of a design and development process where this activity is required. You should seek and record evidence that, where applicable, your organization has implemented a design and development process to allow effective product or service provision, where the requirements for products and services are not defined by your customers or interested parties.
Many companies only make enhancements to, or minor reconfigurations of, mature designs; even so, they may need a design and development process, proportionate to that work, with the related controls. If your organization is ‘design responsible’ but outsources all of its design, it is still responsible for the design, so the documented information called for by clause 8.3 must still be available to it (the outsourced design activity itself is also controlled under 8.4).
What changed in ISO 9001:2026: the requirement itself is unchanged. A new note recognises that the process may run through repeated loops of review, verification, validation and feedback, so an iterative or agile way of working (for example sprints, rapid prototypes or pilot services) is acceptable, provided the planning, input, control, output and change controls of 8.3.2 to 8.3.6 are still applied to each loop.
Determine your organization's arrangements for establishing, implementing and maintaining the design and development process that includes design and development planning, inputs, controls, outputs and changes. If you need a procedure and forms to help control your business's design and development process, click here.
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