ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.8: Design and development transfer

The organization has documented procedures for handing design and development outputs over to manufacturing. These procedures make sure the outputs are checked as fit for manufacture before they become the final production specifications, and that the production capability can achieve the product requirements. The results of the transfer and the conclusions drawn from it are recorded.

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.