Design and Development of Products and Services – General
ISO 9001:2015 – Section 8.3.1
Our consultancy approach ensures organizations establish a structured and controlled process for design and development. The process is scaled to the complexity, risks, and intended use of the products and services, ensuring that customer and regulatory requirements are consistently met.
Scope of Work
1. Framework Establishment
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• Develop a documented design and development procedure.
• Define stages, responsibilities, and approval mechanisms.
• Ensure alignment with organizational strategy and customer expectations.
2. Risk-Based Thinking
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• Identify risks and opportunities at the onset of design.
• Integrate risk management into design decision-making.
• Ensure compliance with statutory and regulatory requirements.
3. Integration with QMS
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• Link design activities with overall quality management system.
• Ensure traceability and alignment with quality objectives.
• Provide mechanisms for review and continual improvement.
Deliverables
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• Documented procedure for design and development (general framework).
• Defined design and development lifecycle with approval points.
• Risk and opportunity integration plan.
• Alignment map showing connection to quality objectives and QMS processes.
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 Process Framework Toolkit | Standardized templates and procedures for design governance. | $1,250/project |
| Risk Integration Package | Tools and checklists for embedding risk-based thinking into design activities. | $1,100/system |
| Design Governance Training | Training for teams on managing design and development within ISO 9001. | $950/session |
| On-Demand Compliance Support | Continuous advisory support for maintaining compliant design processes. | Starting at $120/month |
