Control of Externally Provided Processes, Products, and Services
ISO 9001:2015 – Section 8.4
Our consultancy approach ensures that organizations maintain effective control over all externally provided processes, products, and services. This safeguards compliance with customer, statutory, and regulatory requirements while protecting the integrity of the quality management system (QMS).
Scope of Work
1. Supplier Evaluation and Selection
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• Establish criteria for evaluating, selecting, and monitoring suppliers.
• Assess supplier capability to consistently meet quality and compliance requirements.
• Maintain approved supplier lists with performance records.
2. Control of Externally Provided Processes
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• Define requirements for outsourced processes critical to the QMS.
• Ensure documented agreements specify quality expectations and responsibilities.
• Monitor and review outsourced processes for effectiveness.
3. Verification of Purchased Products and Services
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• Implement incoming inspection and verification methods.
• Ensure conformity of purchased items prior to use or integration.
• Retain records of verification activities and results.
4. Supplier Performance Monitoring
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• Track supplier performance through KPIs such as delivery, quality, and responsiveness.
• Conduct periodic supplier audits and reviews.
• Address supplier nonconformities with corrective actions.
5. Risk-Based Controls
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• Apply risk-based thinking to determine levels of supplier oversight.
• Identify high-risk suppliers and apply enhanced monitoring.
• Develop contingency plans for supplier disruptions.
Deliverables
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• Approved supplier evaluation and selection criteria.
• Supplier audit and monitoring reports.
• Supplier performance scorecards and KPIs.
• Incoming inspection and verification checklists.
• Outsourcing agreements with defined quality responsibilities.
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 |
|---|---|---|
| Supplier Evaluation & Approval Toolkit | Structured templates for supplier assessment, selection, and approval. | $1,350/system |
| Supplier Audit Service | On-site or remote supplier audits with detailed reports and recommendations. | $2,200/supplier |
| Supplier Performance Dashboard | KPI-based dashboard for monitoring supplier performance trends. | $1,100/project |
| Supplier Risk Management Package | Risk profiling tools for supplier classification and contingency planning. | $1,500/system |
