ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.6.2: Review input

The inputs to management review include, at a minimum, information from: feedback; handling of complaints; reports made to regulatory authorities; audits; monitoring and measuring of processes; monitoring and measuring of product; corrective action; preventive action; follow-up on actions from earlier management reviews; changes that might affect the quality management system; recommendations for improvement; and new or revised regulatory requirements that apply.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 4 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.

ISO 19011:2018 · 2 controls

  • 5.7 Reviewing and improving audit programme
  • 6.4.6 Reviewing documented information while conducting audit

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