ISO 13485:2016
Product realization – ISO 13485:2016

ISO 13485:2016 7.5.3: Installation activities

What does 7.5.3 require?

Where appropriate, the organization documents the requirements for installing the medical device and the criteria for accepting that installation has been verified. If the agreed customer requirements let an outside party, not the organization and not its supplier, install the device, the organization supplies documented requirements for installing and verifying the device. Records are kept of installation and verification work done by the organization or by its supplier.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 1 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 19011:2018 · 2 controls

  • 6.3 Preparing audit activities
  • 6.4 Conducting audit activities

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