Nonconformity and Corrective Action
ISO 9001:2015 – Section 10.2
Our consultancy approach helps organizations establish a systematic process for identifying, addressing, and preventing recurrence of nonconformities. By applying structured corrective actions, businesses can maintain compliance, reduce risk, and continuously improve their QMS effectiveness.
Scope of Work
1. Nonconformity Identification and Recording
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• Define methods for detecting nonconformities from audits, customer complaints, inspections, and process deviations.
• Ensure all nonconformities are documented with sufficient detail to support root cause analysis.
• Maintain traceability between detected issues and corrective actions.
2. Corrective Action Process
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• Apply root cause analysis techniques (e.g., 5 Whys, Fishbone Analysis) to identify underlying issues.
• Define and implement corrective actions to eliminate causes of nonconformity.
• Establish timelines, responsibilities, and verification steps to ensure effectiveness.
3. Verification and Effectiveness Review
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• Evaluate the success of corrective actions through follow-up audits or monitoring.
• Record lessons learned to prevent recurrence and foster continual improvement.
• Integrate results into management reviews for accountability.
Deliverables
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• Corrective Action Request (CAR) templates and forms.
• Nonconformity register and tracking log.
• Root cause analysis tools and guides.
• Reports on corrective action effectiveness.
Pricing & Timeline
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• Fee: $3,150.00/month per facility (6-month engagement)
• Estimated Duration: 180 business days
Completion timeline may vary based on client responsiveness and documentation turnaround.
Sample Milestone Plan
| Phase | Key Activities | Core Deliverables |
|---|---|---|
| Month 1 – Planning | Kick-off, scope definition, project charter |
✓ Implementation Plan ✓ Scope Statement & Team Roles |
| Months 1–2 – Design | FSMS drafting, PRP setup, document control systems |
✓ SOPs, PRPs ✓ Controlled Document Framework |
| Months 2–3 – Execution | Competency training, system rollout, records logging |
✓ Training Logs ✓ First Cycle Recordkeeping Evidence |
| Months 3–6 – Validation | Internal audits, reviews, performance monitoring |
✓ Internal Audit Reports ✓ CAPA Logs ✓ Management Review |
| Month 6 – Readiness | Final system check, CB coordination, mock audit |
✓ Pre-Audit Summary ✓ Final CAPA Log ✓ Audit-Day Prep |
Certification Audit Support
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• On-site or remote audit-day presence
• Real-time response to auditor inquiries
• Post-audit support and non-conformance response drafting
Deliverables:
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✓ Audit Representation
✓ NC Response Support
✓ Audit Day Documentation
Project Closure
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• Final FSMS documentation handover
• Executive summary outlining system status and sustainability plan
• Option to transition into maintenance & continuous improvement support
Deliverables:
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✓ Final Document Handover
✓ Close-Out Report
✓ Maintenance Plan Proposal
Additional Compliance Support Options
| Service | Description | Fee |
|---|---|---|
| Corrective Action Management System | Digital or manual system for tracking nonconformities and actions. | $1,250/system |
| Root Cause Analysis Workshop | Practical training for staff on effective investigation methods. | $1,050/session |
| Audit-Ready Corrective Action Package | Documentation and tracking setup aligned with ISO 9001 audit requirements. | $1,400/project |
