Design and Development Inputs
ISO 9001:2015 – Section 8.3.3
Our consultancy ensures organizations identify, review, and control inputs essential for effective design and development. Inputs include functional requirements, regulatory obligations, past performance data, and stakeholder expectations to guarantee outputs meet requirements and intended use.
Scope of Work
1. Customer and Functional Requirements
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• Collect and document customer needs and expectations.
• Translate customer requirements into functional and technical specifications.
• Ensure clarity, completeness, and traceability of requirements.
2. Statutory and Regulatory Considerations
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• Identify legal, regulatory, and industry-specific requirements.
• Integrate compliance needs into design documentation.
• Maintain evidence of regulatory conformity.
3. Standards and Industry Practices
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• Align inputs with recognized international/national standards.
• Benchmark best practices to guide design activities.
• Ensure compatibility with quality, safety, and environmental requirements.
4. Lessons Learned and Knowledge Management
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• Utilize data from similar previous projects.
• Incorporate lessons learned, feedback, and corrective actions.
• Ensure organizational knowledge is captured and applied.
5. Input Validation
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• Review inputs for adequacy, accuracy, and completeness.
• Address conflicting or ambiguous requirements.
• Obtain formal approval of inputs before design activities begin.
Deliverables
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• Documented design input register.
• Traceability matrix linking customer requirements to design outputs.
• Regulatory and statutory compliance checklist.
• Lessons learned integration report.
• Approved and validated input 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
Additional Compliance Support Options
| Service | Description | Fee |
|---|---|---|
| Design Input Capture Workshop | Facilitated session to gather, clarify, and document customer and stakeholder requirements. | $1,350/session |
| Regulatory Requirements Integration Package | Comprehensive identification and embedding of applicable statutory obligations. | $1,600/project |
| Lessons Learned & Knowledge Transfer Toolkit | Tools for capturing and applying historical project data to current design. | $1,100/project |
| Design Input Validation Advisory | Ongoing review and verification of design inputs for adequacy and alignment. | Starting at $120/month |
