Understanding the Organization and Its Context
ISO 9001:2015 – Section 4.1
ISO 9001:2015 requires organizations to identify internal and external factors that could impact their Quality Management System (QMS). This analysis ensures that the QMS is aligned with strategic objectives and can consistently meet customer and regulatory requirements.
Scope of Work
Our services for Clause 4.1 focus on building a solid foundation for your QMS:
1. Internal Context Assessment
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• Evaluate organizational structure, resources, competencies, and culture.
• Identify operational strengths and constraints affecting quality objectives.
2. External Context Assessment
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• Analyze regulatory requirements, market trends, industry standards, and stakeholder needs.
• Identify external risks and opportunities influencing QMS performance.
3. Context and Scope Definition
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• Define the boundaries and applicability of your QMS based on context findings.
• Establish alignment between quality objectives, strategic direction, and customer requirements.
Deliverables
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• Internal and external context analysis report.
• Interested parties overview and summary of key requirements.
• QMS scope statement aligned with ISO 9001:2015.
• Recommendations for integrating context findings into risk and opportunity planning (if any).
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 | Description | Fee |
|---|---|---|
| Starter Package |
• Internal and external factors checklist review. • Basic QMS scope statement. |
Starts at $12 per hour |
| Standard Package |
• Full internal/external context assessment. • SWOT or PESTLE analysis. • Draft QMS scope and integration guidance. |
Starts at $12 per hour |
| Premium Package |
• Standard Package inclusions. • Comprehensive risk and opportunity mapping linked to Clause 6.1. • Leadership workshop to validate QMS scope. • Detailed recommendations for QMS integration. |
Custom Quote |
Optional Add-On Services
| Service | Coverage | Fee |
|---|---|---|
| Context Analysis Workshop | Interactive session with leadership to identify internal/external factors and stakeholder expectations. | Starts at $12 per hour |
| Interested Parties Register | Create a structured register of stakeholders, requirements, and review intervals. | Starts at $12 per hour |
| Context Integration Guidance | Consultation to incorporate context results into your risk management and quality objectives. | Starts at $12 per hour |
