ISO 9001:2015
Operation – ISO 9001:2015

ISO 9001:2015 8.3.1: General

The organization sets up, operates and keeps up to date a process for design and development that is suited to making sure products and services can then be supplied.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 8 controls across 7 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 · 1 control

  • 4.1 General requirements

ISO 14004:2016 · 1 control

  • 8.1.1 General guidance: Operational control

ISO 21001:2018 · 1 control

ISO 21001:2025 · 1 control

ISO 22301:2019 · 1 control

ISO 27701:2019 · 1 control

  • 8.3.1 Obligations to PII principals
  • 6.1 General concepts

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 8 it maps to, and the evidence behind each claim, over MCP and REST.