ISO 9001:2015
Context of the organization – ISO 9001:2015

ISO 9001:2015 4.4: Quality management system and its processes

The organization sets up, operates, keeps up to date and continually improves its QMS, together with the processes the system needs and the way they interact. For each process, and for its use across the organization, it settles the inputs needed and outputs expected, the order in which processes run and how they connect, the criteria and methods (measures and performance indicators included) that make operation and control effective, the resources required, who holds responsibility and authority, which risks and opportunities are being addressed, how the process is evaluated and changed so it achieves what is intended, and how processes and the system are improved. Documented information is kept to support how processes run, and retained to give confidence they ran as planned.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 17 controls across 16 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 10002:2018 · 2 controls

  • 6.1 6.1 General: planning, design and development of the process
  • 6.3 6.3 Activities
  • AS9100D-4.4 Quality Management System and Its Processes

COBIT 2019 · 1 control

  • APO11.01 APO11.01 Establish a quality management system (QMS)
  • IEC62304-4.1 Quality Management System

ISO 14001:2015 · 1 control

  • 4.4 Environmental management system

ISO 21001:2018 · 1 control

  • 4.4 4.4 Management system for educational organizations (EOMS)

ISO 21001:2025 · 1 control

  • 4.4 4.4 Educational organization management system

ISO 22000:2018 · 1 control

  • 4.4 Food safety management system

ISO 22301:2019 · 1 control

  • 4.4 Business continuity management system

ISO 27701:2019 · 1 control

  • 4.4 Customer

ISO 37001:2016 · 1 control

  • 4.4 4.4 Anti-bribery management system

ISO 37301:2021 · 1 control

  • 4.4 Compliance management system

ISO 45001:2018 · 1 control

  • 4.4 OH&S management system
  • 4.4 Energy management system

ISO 55001:2014 · 1 control

  • 4.4 Asset management system

ISO/IEC 42001:2023 · 1 control

  • 4.4 AI management system

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 Context of the organization – ISO 9001:2015

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The graph holds this control, the 17 it maps to, and the evidence behind each claim, over MCP and REST.