ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.1: Management commitment

Top management provides evidence of its commitment to developing and implementing the quality management system and maintaining its effectiveness by communicating the importance of meeting customer and applicable regulatory requirements, establishing the quality policy, ensuring quality objectives are established, conducting management reviews and ensuring resources are available.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 4 controls across 4 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 10006:2003 · 1 control

  • 5.1 Management commitment

ISO 22316 · 1 control

  • ISO22316-05 Management commitment to BCM

ISO/TS 22317:2021 · 1 control

  • ISO22317-05 Management commitment to BCM

ISO/TS 22318:2021 · 1 control

  • ISO22318-05 Management commitment to BCM

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