Control of Externally Provided Processes, Products, and Services – General
ISO 9001:2015 – Section 8.4.1
Our consultancy approach ensures organizations establish the necessary controls to guarantee that externally provided processes, products, and services conform to specified requirements. This includes outsourced processes, purchased products, and services that impact the quality management system (QMS) or customer satisfaction.
Scope of Work
1. Defining Control Requirements
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• Identify all externally provided products, services, and outsourced processes.
• Establish control methods to ensure compliance with statutory, regulatory, and customer requirements.
• Define acceptance criteria for purchased and outsourced deliverables.
2. Maintaining Integrity of the QMS
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• Ensure externally provided processes integrate seamlessly with internal processes.
• Confirm that outsourced operations do not compromise QMS effectiveness.
• Document supplier responsibilities and quality obligations.
3. Ensuring Customer and Regulatory Compliance
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• Verify that all external provisions meet customer requirements.
• Monitor compliance with applicable industry and regulatory standards.
• Retain documented evidence of conformance and verification.
4. Consistency of Control Measures
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• Apply risk-based thinking to determine the level of control required.
• Implement proportionate monitoring based on product/service criticality.
• Regularly review and update external control measures.
Deliverables
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• Register of externally provided products, services, and processes.
• Defined acceptance criteria and documented control methods.
• Compliance verification records and supplier agreements.
• Risk-based control framework for outsourced activities.
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 |
|---|---|---|
| External Provision Control Toolkit | Templates for defining requirements and establishing supplier control mechanisms. | $1,250/system |
| Supplier Integration Workshop | Interactive session on aligning external provider processes with QMS requirements. | $1,500/session |
| Compliance Verification Package | Structured verification methods and records for purchased and outsourced activities. | $1,800/system |
| Risk-Based Control Framework | Risk profiling tools to determine the extent of supplier oversight. | $1,400/project |
