Risk Management Software for ISO 9001 §6.1

QMS2GO is risk management software purpose-built for ISO 9001 §6.1 risk-based thinking. Identify risks and opportunities, score them with a dual inherent/residual matrix, treat them with AI-suggested controls, and verify effectiveness — all linked to the processes, objectives, and CAPA they belong to.

Risk-based thinking, operationalized

ISO 9001:2015 §6.1 requires organizations to determine risks and opportunities that need to be addressed. QMS2GO replaces the forgotten risk spreadsheet with a structured register that lives next to your processes, audits, and management review.

Dual scoring and live heat map

Every risk carries both an inherent and a residual score (likelihood × impact) so auditors can see exactly how much risk your controls remove. The heat map updates as your treatments progress.

AI mitigation suggestions

QMS2GO's AI proposes context-aware controls based on the risk description, source, and treatment strategy you select (avoid, reduce, share, retain). Edit, accept, or regenerate in one click.

Full traceability across the QMS

Risks link bidirectionally to processes, quality objectives, non- conformances, CAPA, and management review inputs — so a single register feeds the entire continuous improvement loop.

Treatment plans people actually complete

Each risk carries an owner, a treatment strategy, dated actions, and an effectiveness check. Overdue treatments surface on the dashboard and in the review and approval inbox instead of sitting unnoticed in a spreadsheet tab, so the register stays a live control rather than an annual formality. When a treatment fails its effectiveness check, QMS2GO routes it into corrective action with the original risk still attached, preserving the chain of evidence an auditor asks to see.

Evidence your auditor can follow

Every scoring change, treatment update, and approval is written to an immutable audit trail with the person, timestamp, and reason recorded. Risk reviews are captured as documented information under ISO 9001 §7.5.2 and §7.5.3, and the register exports as a branded PDF or spreadsheet for the auditor, your customers, or a certification body. Nothing has to be reconstructed from memory the week before the audit.

Built for small manufacturers

QMS2GO is designed for machine shops, fabricators, industrial service companies, and original equipment manufacturers who need ISO 9001 conformity without hiring a full-time quality manager. Setup is guided, the risk register is pre-seeded from your processes and industry context, and the flat subscription covers your whole team rather than charging per seat.

Frequently asked questions

Does QMS2GO cover both risks and opportunities?

Yes. ISO 9001 §6.1 treats opportunities as a first-class concept and so does QMS2GO — same register, distinct treatment strategies, and the same traceability into objectives and management review.

Can we import an existing risk register?

Yes. The Universal Migration Center imports CSV and Excel registers and maps fields to the QMS2GO schema automatically, keeping your existing risk identifiers so historical references stay valid.

How does risk connect to internal audits?

Audit programs are risk-based: higher-scoring processes are audited more often, and findings raised during an audit can be linked back to the risk that predicted them or used to open a new one.

Do we need a separate tool for FMEA-style analysis?

No. Likelihood and impact scoring, detection notes, and residual scoring cover the analysis most ISO 9001 shops need, and the register links to root cause analysis when a deeper investigation is warranted.


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