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Available ISO 9001 Clause 10.2 — Nonconformity and Corrective Action ISO 9001 Pack

ClearVue CAPA

From nonconformance to verified fix — fully documented.

End-to-end corrective action lifecycle built to ISO 9001 §10.2 — from NCR intake through structured root cause analysis, action planning, implementation, and time-delayed effectiveness verification. Every stage transition is timestamped, access-scoped, and audit-ready. CAPA ships at two levels: CAPA (Growth+) covers NCR intake, action assignment, 5-Whys, and effectiveness verification; CAPA Advanced (Scale+) adds fishbone/8D root-cause analysis, recurrence detection, and linked Change Control.

Key Capabilities

✓ Triage gate with 3×3 risk scoring — not every finding requires a full CAPA (ISO 10.2.1a)
✓ Root cause analysis with a 5-Why builder, plus free-text fallback
✓ Correction, corrective action, and preventive action types — the ISO-exact distinction auditors probe
✓ Position-based assignment with supervisor escalation — survives personnel changes
✓ Time-delayed effectiveness verification (30–120 days by severity, tenant-configurable)
✓ Closure requires a documented Effective verification result — cannot be bypassed on either path
✓ My CAPA Actions worklist keeps action items separate from approval notifications
✓ Compliance dashboard: open CAPAs, overdue, and stage breakdown
✓ Auto-CAPA creation on critical findings and out-of-service triggers
✓ Full audit trail with auto-numbering, stage notes, and locked closure records
✓ Advanced (Scale+): Ishikawa (fishbone) & 8D root-cause builders
✓ Advanced (Scale+): recurrence detection and chronic-reopen alerts
✓ Advanced (Scale+): linked Change Control on corrective actions

How This Satisfies ISO 9001 Clause 10.2

Clause 10.2.2 requires documented evidence of the nature of the nonconformity, actions taken, and results — including whether corrective action was effective. ClearVue CAPA satisfies this with a structured lifecycle where effectiveness verification is mandatory and gates closure, producing exactly the documented evidence trail certification bodies and customer auditors look for.

Bundle

ClearVue ISO 9001 Pack

CAPA is included in the ISO 9001 Pack — a bundled offering with Document Control, Risk Register, Audit Manager, CAPA, and Insights. The fastest path from zero to audit-ready.

See Pack Pricing

Works With

Coming Soon

Audit Manager

Clause 9.2

Available

Workflow Engine

Clause 5.2 / 7.4

Available

Insights

Clause 9.1 / 9.3

See CAPA in Action

Request a live demo and we will walk you through exactly how this module handles your ISO 9001 requirements.

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