Full ISO 9001 System Implementation & Certification Setup Package
Comprehensive QMS Implementation – From Framework to Audit Day
This project-based consultancy package is designed to support your organization in establishing, implementing, and maintaining a Quality Management System (QMS) that conforms with ISO 9001:2015 certification requirements. Our approach integrates ISO-based standards, risk-based thinking, and customer/regulatory compliance to ensure certification readiness and sustainable performance.
Scope of Work
1. QMS Framework Development (ISO 9001-Based)
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• Establishment of a documented QMS aligned with ISO 9001:2015 structure and requirements
• Development of process-based controls including supplier management, customer requirements, operational risks, and continual improvement
• Integration of quality objectives, risk registers, and organizational context analysis
• Development of a Quality Culture Plan with governance mechanisms and measurable targets
2. Documented Information & Operational Controls
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• Identification of processes requiring documented procedures, work instructions, and controlled forms
• Drafting of site-specific documentation including policies, SOPs, records, monitoring templates, and training materials
• Provision of digital-ready templates aligned with ISO 9001 clause 7.5 – Documented Information
3. Document Control & Record-Keeping System Setup
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• Configuration of a document management process ensuring version control, access control, and traceability
• Setup of registers for monitoring and measurement, internal audits, CAPA, and management reviews
4. Quality Culture & Performance Monitoring
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• Establishment of performance metrics and KPIs for QMS effectiveness
• Creation of internal assessment tools (surveys, dashboards, review templates) and senior management review frameworks
5. Internal Team Development & Competence Building
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• Identification of QMS roles (e.g., Quality Manager, internal auditors, process owners)
• Guidance on meeting ISO 9001 training and competence requirements
6. Certification Readiness & Audit Preparation
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• Clarification of certification scope, product/service categories, and exclusions
• Internal audits, management review, and mock audit implementation
• Development and tracking of corrective and preventive actions (CAPA)
7. (Optional) Sustainability & ESG Integration
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• Advisory on aligning QMS practices with sustainability initiatives and ESG reporting goals
• Development of environmental and social responsibility policies supporting customer expectations
Deliverables
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• Fully documented ISO 9001-compliant QMS
• Controlled documentation system (digital-ready)
• SOPs, records, training modules tailored to your organization
• Quality culture tools and monitoring templates
• Internal audit package and management review framework
• Audit readiness report with pre-audit findings and CAPA log
Pricing & Timeline
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• Fee: $3,150.00/month per site (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 | QMS drafting, process setup, document control systems |
✓ SOPs, Process Maps ✓ 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 |
