ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.6: Design and development verification

Verification of design and development follows planned, documented arrangements and confirms that the outputs satisfy the input requirements. The organization documents verification plans setting out the methods, the acceptance criteria and, where appropriate, statistical techniques together with the reasoning behind the sample size. If the intended use means the device must connect or interface with other devices, verification must show the outputs meet the inputs in that connected state. Records are kept of verification results, conclusions and any actions needed.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 6 controls across 4 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/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 6 it maps to, and the evidence behind each claim, over MCP and REST.