ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.4: Design and development outputs

Outputs of design and development must satisfy the input requirements; give suitable information for purchasing, for production and for service provision; include or refer to the criteria for accepting the product; and set out the product characteristics that are essential to using it safely and properly. The outputs must be in a form that allows them to be checked against the inputs, must be approved before they are released, and are kept as records.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 7 controls across 5 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 31000:2018 · 1 control

  • 5.4 Design

ISO 9001:2015 · 1 control

  • 8.3.5 Design and development outputs

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

Query this from an agent

The graph holds this control, the 7 it maps to, and the evidence behind each claim, over MCP and REST.