Control of Externally Provided Processes, Products, and Services – Type and Extent of Control
ISO 9001:2015 – Section 8.4.2
Our consultancy approach ensures that organizations determine the type and extent of control applied to external providers, based on the impact of their processes, products, and services on the QMS and customer satisfaction. Controls are tailored proportionally, using risk-based thinking, to ensure compliance and effectiveness.
Scope of Work
1. Risk-Based Determination of Control
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• Assess the significance of externally provided products and services on customer requirements.
• Classify suppliers and outsourced processes based on risk and criticality.
• Determine proportional control measures aligned with potential impact.
2. Integration into Core Operations
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• Define roles and responsibilities for managing supplier interactions.
• Ensure monitoring and verification activities are incorporated into operational processes.
• Align supplier controls with business objectives and compliance requirements.
3. Verification and Monitoring Activities
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• Conduct supplier audits, inspections, and performance evaluations.
• Establish acceptance and rejection criteria for delivered goods and services.
• Maintain consistent oversight through periodic reviews and performance reports.
4. Evidence and Documentation
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• Retain documented information on the criteria used to establish control levels.
• Provide traceability of supplier selection, monitoring, and evaluation outcomes.
• Demonstrate due diligence in supplier management to external auditors.
Deliverables
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• Supplier risk classification matrix.
• Documented criteria for determining control levels.
• Supplier monitoring and audit reports.
• Performance evaluation records and improvement action plans.
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 Risk Profiling Package | Tools for categorizing suppliers and defining proportional controls. | $1,600/system |
| Supplier Audit & Evaluation Service | Comprehensive external provider audit and reporting framework. | $2,000/system |
| Control Criteria Documentation Toolkit | Templates for defining and recording control criteria. | $1,100/project |
| Ongoing Supplier Performance Dashboard | Digital tools for real-time monitoring and reporting of supplier performance. | $1,500/system |
