ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.2: Customer focus

Top management makes sure both the customer's requirements and the regulatory requirements that apply are identified and satisfied.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 3 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • AS9100D-5.1.2 Customer Focus and Product Safety

ISO 27701:2019 · 1 control

  • 4.4 Customer

ISO 9001:2015 · 1 control

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 Management responsibility – ISO 13485:2016

Query this from an agent

The graph holds this control, the 3 it maps to, and the evidence behind each claim, over MCP and REST.