Six Sigma Quality International

Quality risk assessment for certification services, especially in sustainability and accreditation, follows ISO 9001 Clause 6.1 and ISO 31000 principles to systematically identify, assess, and mitigate risks that could impact service conformity, customer satisfaction, and compliance. The process involves structured tools like FMEA (Failure Mode and Effects Analysis) and risk registers, focusing on operational, compliance, and competency risks specific to each department.​

ISO 9001 Clause 6.1 and ISO 31000 Principles

ISO 9001 Clause 6.1 requires organizations to identify risks and opportunities, plan actions to address them, and integrate these actions into quality management processes. ISO 31000 provides a broader risk management framework, emphasizing principles, a structured process, and continuous improvement. Both standards recommend a PDCA (Plan-Do-Check-Act) cycle for risk management, ensuring ongoing evaluation and adaptation.​

Risk Identification and Assessment

Risks are identified by department—such as quality control (instrument errors), procurement (supplier delays), or competency (staff training gaps). Each risk is assessed using severity (impact), occurrence (likelihood), and detection, with the Risk Priority Number (RPN) calculated as severity × occurrence × detection. Risks with high RPN (e.g., >80) are prioritized for mitigation.​

Mitigation Planning and Tools

Proactive mitigation plans are developed for high-priority risks, using tools like FMEA or risk registers. Mitigation actions may include additional training, improved controls, supplier audits, or process redesign. The effectiveness of these actions is monitored and documented, supporting continuous improvement and compliance.​

Mitigation Strategies

Implement actions with owners and timelines, then monitor via audits.​

Engineering controls: Automate traceability for audit documents.

Training: Annual sessions on ISO 9001 risk-based thinking.

Review: Update register quarterly, integrating with management reviews.​

Track effectiveness through reduced RPN post-action and nonconformity rates. Tailor to ventures like UKJAS or GGBC by adding ESG-specific risks.

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