Design and Development Controls
ISO 9001:2015 – Section 8.3.4
Our consultancy ensures organizations establish systematic controls throughout the design and development process. These controls verify that design activities are planned, executed, monitored, and reviewed to achieve conformity with requirements, prevent errors, and enable effective decision-making at key stages.
Scope of Work
1. Design Planning and Review
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• Define control stages, review points, and approval gates.
• Establish roles and responsibilities for oversight and decision-making.
• Conduct formal design reviews to verify adequacy and identify risks early.
2. Verification Activities
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• Assess design outputs against established inputs.
• Use simulations, calculations, or testing methods to confirm compliance.
• Document verification results and corrective actions.
3. Validation Activities
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• Confirm the product/service fulfills customer and regulatory requirements.
• Perform trials, prototypes, or pilot runs to validate design effectiveness.
• Ensure validation occurs prior to delivery or implementation.
4. Change Control
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• Implement structured processes for handling design changes.
• Reassess risks, impacts, and compliance when modifications occur.
• Maintain traceability of changes, approvals, and justifications.
5. Cross-Functional Involvement
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• Engage relevant functions (engineering, operations, quality, customers).
• Ensure effective communication between teams for alignment.
• Capture feedback loops to strengthen the design cycle.
Deliverables
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• Documented design control plan.
• Records of design reviews, verification, and validation.
• Approved design change request log.
• Evidence of stakeholder involvement and decision-making.
• Compliance reports for regulatory/standard adherence.
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 Control Framework Workshop | Establishes structured checkpoints and approval mechanisms for design projects. | $1,400/session |
| Verification & Validation Toolkit | Includes test templates, validation plans, and traceability matrices. | $1,650/project |
| Change Control Register Setup | Digital-ready system for documenting, assessing, and approving design changes. | $1,200/project |
| Ongoing Design Review Advisory | Continuous expert support during design reviews and control meetings. | Starting at $150/month |
