QPS 6.1-01 Actions to Address Risks

ISO 9001:2026 Quality Procedure Specification

Updated for 2026 This procedure has been refreshed for the ISO 9001:2026 revision — content aligned to the new edition, a streamlined two-form package (Risk List and Risk Treatment Plan) delivered as live editable tables, and a new section on environmental and climate-change risk (E-risks).

  • Builds actions to address risks into decision-making at every level through a PDCA cycle — planning the framework, integrating it into processes, evaluating effectiveness, and achieving improvement
  • Complete risk-assessment method: identification (cause-and-effect diagrams, brainstorming), analysis of risk level by severity and likelihood of occurrence on a 10-point scale, and evaluation and ranking against defined risk criteria
  • Six risk-treatment options and a Risk Treatment Plan for High and Critical risks; quality objectives and operational controls for the rest
  • Environmental risk (E-risk) assessment for climate-change and environmental impact — new in the ISO 9001:2026 edition
  • Corresponds to ISO 9001:2026 clause 6.1 and the risk-management principles of ISO 31000 — reviewed and approved by experienced ISO 9001 quality auditors
QPS 6.1-01 Actions to Address Risks

Description

Procedure for planning, integrating, and evaluating actions to address risks across every QMS process under ISO 9001:2026 clause 6.1. It runs as a PDCA cycle in four phases: planning the risk-management framework, integrating and executing it in the processes, evaluating its effectiveness, and achieving improvement. Responsibilities and authorities are defined for Top Management, the Quality Manager, the Risk Manager, Process Owners, and Risk Owners.

The core method is risk assessment — identification using cause-and-effect diagrams and brainstorming, analysis of each risk's level by consequence and likelihood on a 10-point scale, and evaluation that ranks risks and compares them against the organization's risk criteria (default threshold of 3.0). Risks above the threshold receive a Risk Treatment Plan; the ISO 9001:2026 edition adds environmental risk (E-risk) assessment for processes that may affect the environment or climate change, with input from the Environmental Department. Risk actualization for a modified process is triggered from QPS 10.2-01 Corrective Action, and Risk List reviews are a standing input to QPS 9.2-01 Internal Audit.

Who Needs This Procedure

This procedure is for organizations implementing or transitioning to ISO 9001:2026 that need a documented, repeatable way to run risk-based thinking, not just name it. It gives the Quality Manager and Risk Manager a framework to roll out across processes, and gives each Process Owner and Risk Owner a concrete method for identifying, scoring, and treating the risks in their own process. It also suits organizations bringing environmental and climate-change risk into the QMS alongside quality risk.

Included in the Package

Quality Procedure Specification

17-page MS Word document covering the four-phase risk-management framework, roles and authorities, communication and consultation, context and situation analysis, risk assessment (identification, analysis, evaluation), risk treatment, environmental (E-)risk assessment, effectiveness evaluation, and the process criteria. Includes:

  • Annex 1 / QSF 6.1-01-01 'Risk List' for Processes — capture each risk's title, probable causes, potential consequences, and its severity, occurrence, and overall risk scores
  • Annex 2 / QSF 6.1-01-02 'Risk Treatment Plan' — risk-reduction measures, responsible people, due dates, and required resources for High and Critical risks
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FAQ

What's new in the ISO 9001:2026 version of this procedure?
The procedure is aligned to ISO 9001:2026 and adds environmental risk (E-risk) assessment for processes that may affect the environment or climate change — with its own consequences scale and Environmental Department experts on the assessment team (section 4.3.3). The form package is streamlined to two live, editable tables: a Risk List and a Risk Treatment Plan.
What's included in the package?
The 17-page procedure document plus two forms: a Risk List (QSF 6.1-01-01, Annex 1) for capturing and scoring each process risk, and a Risk Treatment Plan (QSF 6.1-01-02, Annex 2) for planning risk-reduction measures, owners, due dates, and resources.
Can I customize it?
Yes — delivered as an editable MS Word document.

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QPS 10.2-01 Corrective Action Updated for 2026

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