ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.3.2: Design and development planning

The organization plans and controls how the product is designed and developed, and keeps the planning documents up to date as the work moves forward. The planning documents set out the stages of design and development; the reviews each stage needs; the verification, validation and design transfer work suited to each stage; responsibilities and authorities; how design outputs will be traced back to design inputs; and the resources required, including staff competence.

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

ISO 31000:2018 · 1 control

  • 5.4 Design

ISO 9001:2015 · 1 control

  • 8.3.2 Design and development planning

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.