Control of Changes
ISO 9001:2015 – Section 8.5.6
Our consultancy supports organizations in effectively managing and controlling changes that may impact production, service provision, or customer requirements. By implementing structured change control processes, organizations can prevent unintended consequences, maintain conformity, and ensure transparency with stakeholders.
Scope of Work
1. Change Identification & Evaluation
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• Establish a formal process for requesting and documenting changes.
• Evaluate potential impacts on product quality, service delivery, compliance, and resources.
• Involve relevant stakeholders in change assessment.
2. Approval & Authorization
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• Define clear authority levels for change approvals.
• Ensure top management or designated personnel review high-impact changes.
• Maintain documented approval records.
3. Implementation & Communication
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• Develop structured plans for implementing approved changes.
• Communicate changes to affected functions, suppliers, and customers as applicable.
• Update work instructions, process maps, and training materials to reflect changes.
4. Monitoring & Verification
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• Track the effectiveness of implemented changes.
• Conduct follow-up reviews to verify desired outcomes were achieved.
• Document corrective actions if adverse effects occur.
Deliverables
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• Documented change control procedure.
• Change request and approval templates.
• Updated process and procedure documents reflecting changes.
• Change impact assessment reports.
• Verification and monitoring records.
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 |
|---|---|---|
| Change Control Framework Setup | Complete procedures and templates for managing operational changes. | $1,750/system |
| Change Impact Assessment Workshop | Practical training on assessing risks and impacts of proposed changes. | $1,200/session |
| Change Communication Toolkit | Templates and guidance for effective internal/external communication of changes. | $950/project |
| Post-Implementation Review Support | Independent assessment of change effectiveness and compliance assurance. | $1,500/project |
