ISO 13485:2016
Management responsibility – ISO 13485:2016

ISO 13485:2016 5.4.1: Quality objectives

Top management makes sure quality objectives are set at the relevant functions and levels of the organization, including the objectives needed to satisfy product requirements and the regulatory requirements that apply. The objectives must be measurable and must be in line with the quality policy.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 5 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 19011:2018 · 2 controls

  • 5.2 Establishing audit programme objectives
  • 6.4.5 Audit information availability and access
  • AS9100D-6.2 Quality Objectives and Planning to Achieve Them

ISO 10005:2005 · 1 control

  • 5.4 Quality objectives

ISO 9001:2015 · 1 control

  • 6.2 Quality objectives and planning to achieve them

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