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The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.

ISO 9001: Design and development 7.3

Many organizations undertake enhancements/modifications or minor reconfiguration of mature designs in order to address some or all of section 7.3. Some organizations subcontract design work will manage this outsourced process via section 4.1 and section 7.4 of ISO 9001:2008.

Such organizations may have to introduce a comprehensive design system or process, they may have to address design and development as it is applicable to the organization.

If the organization is responsible for design and outsources this process, all records of the design process must be maintained by the company that is responsible for design. The design and development process has seven phases, each with its own input and ouputs which act in sequence:

  1. Design & Development Planning 7.3.1
  2. Design & Development Input 7.3.2
  3. Design & Development Output 7.3.3
  4. Design & Development Review 7.3.4
  5. Design & Development Verification 7.3.5
  6. Design & Development Validation 7.3.6
  7. Control of Design & Development Changes 7.3.7