AI-drafted controlled documents
Quality Manual, procedures, SOPs and forms — clause-mapped, versioned and approval-gated.
ISO 9001 Quality Management Software
ISO 9001 Software for a Living Quality Management System
Run your ISO 9001 QMS as one connected system — not a folder of documents. Map clauses, control documents, run audits, close CAPAs and evidence continual improvement, with AI drafting the busywork.
A QMS that proves itself
ISO 9001 certification depends on evidence, not just intent: controlled documents, traceable clause mapping, audit records, and a closed loop from finding to corrective action. ISOXPERT Compliance360 captures your organization once — sites, processes, products, responsibilities — then uses that context to draft your Quality Manual, procedures and forms, plan and run audits, and keep every clause traceable to real evidence.
Key capabilities
Everything ISO 9001 clause 4–10 requires, in one workspace.
Clause mapping & context
Map ISO 9001 clauses to sites, processes and products, with included/excluded justification.
Audit management
Plan internal audits, capture findings and raise NCRs directly from the audit.
NCR & CAPA lifecycle
Root-cause analysis and corrective actions, AI-assisted, with signed-off closure.
Risk-based thinking
A risk register linked to processes and products, with mitigation and CAPA linkage.
Management review
Audit results, NCR/CAPA status, risk and objectives auto-summarised for review.
How it works
- Set up your organization — sites, departments, processes, products and the standards you certify to.
- Let AI draft your documentation — Quality Manual, procedures, SOPs and forms, clause-mapped from your setup.
- Run audits and raise NCRs — plan by clause and department, capture findings with evidence.
- Close the loop with CAPA — AI-assisted root cause and actions, verified before sign-off.
- Feed management review — every input auto-summarised, ready for the review meeting.
Standards & frameworks
ISO 9001ISO 14001ISO 45001ISO 27001ISO 22301ISO 13485 / QMSR21 CFR Part 11GDPR / PDPL
Why ISOXPERT Compliance360
- One system of record — documents, audits, NCRs, CAPAs and risk share the same data, not five spreadsheets.
- AI-assisted drafting — a first draft of every controlled document, grounded in your actual setup.
- Audit-ready by default — evidence is captured as work happens, not reconstructed before the audit.
- Scales with you — add ISO 14001, 45001, 27001 or 22301 on the same platform, same data.
Frequently asked questions
Does ISOXPERT Compliance360 cover ISO 9001 clause by clause?
Yes. The clause map records included/excluded status, justification, and the sites, processes and products each clause applies to — feeding the Statement of Applicability and your controlled documentation.
Can it generate my Quality Manual and procedures?
Yes. The AI Documentation Toolkit drafts manuals, procedures, SOPs/work instructions and forms grounded in your organization setup, which you review and approve.
Does it handle NCRs and CAPAs?
Yes. Nonconformities can be raised from audits or operations and are linked to CAPAs for investigation, corrective action and verification, with role-gated closure.
Can I run multiple ISO standards on one platform?
Yes — ISO 9001, 14001, 45001, 27001, 22301 and more share the same organization setup, documents and audit engine.
See it for yourself
One Platform. Unlimited Possibilities. Total Compliance.