ISO 9001:2015
Operation – ISO 9001:2015

ISO 9001:2015 8.3.6: Design and development changes

The organization identifies, reviews and controls changes made to products and services while they are being designed and developed or afterwards, as far as needed to keep conformity to requirements from being harmed. It retains documented information on each change, on what the reviews found, on who authorized the change, and on the actions taken to avoid harm to conformity.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 11 controls across 8 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 13485:2016 · 2 controls

  • 7.3 Design and development
  • 7.3.9 Control of design and development changes
  • ISO-50001-8.2 Design
  • 8.2 Design

COBIT 2019 · 1 control

  • BAI03.09 BAI03.09 Manage changes to requirements

ISO 10005:2005 · 1 control

  • 5.11 Design and development

ISO 21001:2018 · 1 control

  • 8.3.6 8.3.6 Design and development changes

ISO 21001:2025 · 1 control

  • 8.3.6 8.3.6 Design and development changes

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 Operation – ISO 9001:2015

Query this from an agent

The graph holds this control, the 11 it maps to, and the evidence behind each claim, over MCP and REST.