Internal Audit
ISO 9001:2015 – Section 9.2
Our consultancy approach helps organizations establish and maintain an effective internal audit program to evaluate the performance of their Quality Management System (QMS). Internal audits ensure ongoing compliance, highlight opportunities for improvement, and demonstrate commitment to continual quality assurance.
Scope of Work
1. Audit Program Development
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• Define the audit program considering importance of processes, risks, and prior results.
• Establish audit frequency, scope, methods, and responsibilities.
• Ensure objectivity and impartiality in the audit process.
2. Audit Planning and Execution
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• Prepare audit plans and checklists aligned with ISO 9001:2015 requirements.
• Conduct process-based audits to evaluate conformity with QMS criteria.
• Document evidence of compliance and nonconformity.
3. Reporting and Communication
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• Provide clear audit findings, including nonconformities, observations, and opportunities.
• Communicate results to relevant management.
• Ensure findings are traceable and actionable.
4. Corrective Actions and Follow-Up
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• Support development of corrective action plans.
• Verify the effectiveness of implemented actions.
• Provide continual improvement insights for QMS strengthening.
Deliverables
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• Internal audit program and annual schedule.
• Audit checklists and planning templates.
• Internal audit reports with documented findings.
• Corrective action tracking system.
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 |
|---|---|---|
| Internal Audit Program Setup | Complete design and implementation of audit frameworks. | $1,800/system |
| Internal Auditor Training | Hands-on training for staff to conduct ISO 9001-compliant audits. | $1,250/session |
| Audit Software Subscription | Digital solution for managing schedules, findings, and corrective actions. | Starting at $99/month |
