Clause 6.1 requires organisations to determine the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results, prevent or reduce undesired effects, and achieve continual improvement.
Identify
Identify risks from context, interested parties, process performance, customer feedback and strategic planning.
Analyse
Assess likelihood and severity using a consistent scoring methodology. Consider both inherent and residual risk.
Treat
Avoid, reduce, transfer or accept risks. For opportunities: exploit, enhance or share. Document planned actions.
Monitor
Review risks at planned intervals, during management review, and after significant changes. Update the register.
Risk Register
All recorded risks and opportunities. Filter, edit, export — data is saved automatically in this page.
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Last updated: January 2025 | Effective date: January 2025
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Common Questions
ISO 9001 — Frequently Asked Questions
Quick answers about the ISO 9001 gap analysis tool, data privacy, audit preparation, and ISO Xpert consulting.
What is the ISO 9001 gap analysis tool and how does it work?
The ISO 9001 gap analysis tool is a free browser-based checklist that compares your current management system against the clauses of ISO 9001. You answer clause-by-clause questions and rate each requirement as Compliant, Partial or Non-compliant. The tool calculates a live compliance score, highlights gaps on a heat-map, captures evidence and corrective-action notes, and exports the full assessment as JSON, CSV, TXT or print-ready PDF for management review and Stage 1 / Stage 2 audit preparation.
Is the ISO 9001 gap analysis tool really free to use?
Yes — the ISO 9001 tool is 100% free with no sign-up, no email capture, no credit card, no watermarks, and no usage limits. It runs entirely in your browser; nothing is transmitted to ISO Xpert servers. You can clear or export your data at any time.
Where is my ISO 9001 assessment data stored?
All ISO 9001 assessment data is stored locally in your browser’s storage. Nothing is uploaded to our servers. This makes the tool GDPR-friendly and suitable for confidential audit data classified up to Restricted. Export anytime as JSON (re-importable), CSV (Excel-pivotable), TXT (executive summary) or PDF (audit-trail evidence).
Can I use this tool to prepare for ISO 9001 certification or surveillance audits?
Yes. The ISO 9001 gap analysis is designed to support preparation for certification by UKAS-, IAS- or ANAB-accredited bodies. Use the exported report as evidence of internal audit, feed it into management review, and prioritise high-severity non-conformities ahead of Stage 1 / Stage 2 visits. ISO Xpert consultants can assist with documented information, internal audits and full implementation if required.
How long does a ISO 9001 gap analysis typically take?
Most users complete an initial ISO 9001 gap analysis in 60 to 120 minutes for a single site, depending on system maturity and clause depth. The tool auto-saves continuously, so you can pause, switch devices via JSON export/import, and resume at any time. Re-assessments after corrective action usually take 20 to 40 minutes.
Does ISO Xpert offer ISO 9001 consulting or training?
Yes. ISO Xpert Ltd (London, UK) provides ISO 9001 gap analysis consulting, internal audits, Stage 1 and Stage 2 certification preparation, lead auditor / internal auditor training, and full management-system implementation. Contact info@iso-xpert.com or WhatsApp +44 7853 109840.
