Management system guidance
8.0 Operation
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8.3 Design and development of products and services
Define your organization’s arrangements for establishing, implementing and maintaining a design and development process including planning, inputs, controls, outputs and changes (see 8.3.1 to 8.3.6).
Climate change is not a separate requirement of clause 8.3. However, where your review of context (4.1) and of interested party requirements (4.2) shows that climate-related factors matter to your customers or regulators, treat them like any other requirement and feed them into your design and development inputs (8.3.3).
What changed in ISO 9001:2026: the six sub-clauses of 8.3 keep their numbers and titles, and most of the content is unchanged. There are three changes: a new note in 8.3.1 recognising that design can be iterative; item g) of 8.3.2, which now covers customers and any other relevant interested parties (2015 said customers and users); and a new note in 8.3.3 accepting that inputs can develop as the design progresses. Clauses 8.3.4, 8.3.5 and 8.3.6 are unchanged.
- 8.3.1 Design and Development General
- 8.3.2 Design and Development Planning
- 8.3.3 Design and Development Inputs
- 8.3.4 Design and Development Controls
- 8.3.5 Design and Development Outputs
- 8.3.6 Design and Development Changes
If you need a procedure and forms to help control your business's design and development process, click here.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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