Determining the Scope of the Quality Management System
ISO 9001:2015 – Section 4.3
ISO 9001:2015 Clause 4.3 requires organizations to define the boundaries and applicability of their Quality Management System (QMS). This scope establishes the extent of processes, functions, and locations covered by the QMS, ensuring clarity for certification audits and compliance management.
Scope of Work
Our services for Clause 4.3 ensure your QMS scope is accurate, defensible, and audit-ready:
1. Scope Determination Review
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• Assess organizational structure, processes, and product/service offerings.
• Determine applicability of ISO 9001 requirements based on organizational context and stakeholder needs.
2. Process and Boundary Definition
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• Identify all processes covered under the QMS, including outsourced activities.
• Define physical and operational boundaries of the QMS (sites, facilities, and divisions).
3. Scope Statement Development
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• Draft a clear, compliant QMS scope statement suitable for inclusion in the Quality Manual.
• Validate scope with top management to ensure alignment with strategic goals.
4. Audit-Ready Integration
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• Prepare supporting documentation to demonstrate rationale for exclusions (if any).
• Provide recommendations to integrate scope into your QMS documentation framework.
Deliverables
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• Process boundary assessment report.
• Draft QMS scope statement aligned with ISO 9001:2015.
• Exclusions justification (if applicable).
• Integration guidance for Quality Manual and supporting documentation.
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
Service Packages & Pricing
| Package | Coverage | Fee |
|---|---|---|
| Starter Package |
• Review of existing documentation. • Basic QMS scope statement draft. |
Starts at $12 per hour |
| Standard Package |
• Site/process boundary mapping. • Validation of scope with leadership. • Documentation review for exclusions. |
Starts at $12 per hour |
| Premium Package |
• Full process and boundary analysis. • Comprehensive integration into the Quality Manual. • Workshop to review and finalize scope. |
Custom Quote |
Optional Add-On Services
| Service | Coverage | Fee |
|---|---|---|
| Scope Validation Workshop | Leadership session to validate QMS scope decisions. | Starts at $12 per hour |
| Quality Manual Development | Complete drafting or revision of your Quality Manual with updated scope. | Custom Quote |
| Annual Scope Review | Yearly review and updates to ensure ongoing accuracy of QMS scope. | Starts at $12 per hour |
