ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.3: Quality policy

Top management makes sure the quality policy fits the purpose of the organization; commits the organization to meeting requirements and to keeping the quality management system effective; gives a framework within which quality objectives are set and reviewed; is communicated to, and understood by, people in the organization; and is reviewed so it remains suitable.

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-5.2 Quality Policy

ISO 19011:2018 · 1 control

ISO/IEC 38500:2024 · 1 control

  • 5.12 Viability and performance over time

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

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