ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.6.3: Review output

What does 5.6.3 require?

The output of management review is recorded. It includes the inputs that were reviewed and any decisions and actions on: improvements needed so that the system, and every process in it, stays suitable, adequate and effective; improving product in relation to customer requirements; changes needed in response to new or revised regulatory requirements that apply; and the resources needed.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

BCBS 239 · 1 control

  • BCBS239-P12 Review

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