ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.3: Design and development inputs

The organization determines and records the design and development inputs that relate to product requirements. These include the functional, performance, usability and safety needs arising from the intended use; applicable regulatory requirements and standards; relevant risk management outputs; information from earlier similar designs where appropriate; and any further requirements essential to designing the product and its processes. The inputs are reviewed for adequacy and approved. Requirements must be complete and unambiguous, must be capable of verification or validation, and must not contradict each other.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 8 controls across 6 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • ISO-50001-8.2 Design
  • 8.2 Design

ISO 10005:2005 · 1 control

  • 5.11 Design and development

ISO 19011:2018 · 1 control

  • 5.5.3 Selecting and determining audit methods

ISO 31000:2018 · 1 control

  • 5.4 Design

ISO 9001:2015 · 1 control

  • 8.3.3 Design and development inputs

ISO/IEC 23894:2023 · 1 control

  • 5.4 Design

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Product realization – ISO 13485:2016

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The graph holds this control, the 8 it maps to, and the evidence behind each claim, over MCP and REST.