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The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.

If you're looking for more up-to-date guidance on ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018, click here.

Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement and document your organization's quality management system or integrated management system.

ISO 9001:2008: Design and development 7.3

This guidance has been updated for ISO 9001:2015, please click here to review the changes. 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