Changes to Requirements for Products and Services
ISO 9001:2015 – Section 8.2.4
Our consultancy approach ensures organizations establish a controlled process to manage and communicate changes to customer, statutory, and regulatory requirements. This prevents misalignment, ensures feasibility, and maintains traceability across the value chain.
Scope of Work
1. Identification of Changes
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• Define processes for capturing changes in customer, statutory, or regulatory requirements.
• Establish formal change request and notification mechanisms.
• Ensure timely identification of changes from all relevant sources.
2. Review and Validation
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• Assess the impact of changes on quality, compliance, delivery, and cost.
• Confirm organizational capability and resources to address updated requirements.
• Conduct cross-functional reviews to validate feasibility.
3. Communication and Documentation
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• Communicate changes clearly to all relevant internal stakeholders.
• Confirm changes with customers to ensure alignment and avoid misunderstandings.
• Update documented information (contracts, specifications, records) accordingly.
4. Traceability and Records
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• Maintain logs of requirement changes, reviews, approvals, and communications.
• Ensure traceability between original requirements and revised ones.
• Integrate change records into the quality management system.
5. Continual Improvement
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• Analyze recurring requirement changes to identify trends and root causes.
• Implement process improvements to reduce frequency of requirement modifications.
• Review change management effectiveness in management reviews.
Deliverables
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• Documented procedure for requirement change management.
• Change request and approval templates.
• Change communication matrix and stakeholder update records.
• Requirement change log with traceability.
• Management review inputs on requirement changes.
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 |
|---|---|---|
| Requirement Change Control Toolkit | Templates, workflows, and checklists for controlled change management. | $1,250/project |
| Impact Assessment Package | Detailed risk and feasibility assessments for requirement modifications. | $1,800/system |
| Change Management Training | Practical training to strengthen awareness and skills in handling requirement changes. | $900/session |
| Ongoing Compliance Monitoring Support | Continuous support for tracking, logging, and managing requirement changes. | Starting at $110/month |
