Control of Externally Provided Processes, Products, and Services – Information for External Providers
ISO 9001:2015 – Section 8.4.3
Our consultancy approach ensures organizations communicate clearly and effectively with external providers, delivering all necessary information to ensure conformity of purchased products, services, and outsourced processes. This communication establishes expectations upfront, reduces risks, and drives supplier alignment with organizational and customer requirements.
Scope of Work
1. Defining Requirements for Suppliers
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• Communicate the processes, products, and services to be provided, including specifications.
• Define approval requirements for products, services, methods, processes, and equipment.
• Establish competency requirements for supplier personnel involved in service or product provision.
2. Verification and Validation Requirements
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• Inform suppliers of verification or validation activities that the organization intends to perform.
• Define acceptance criteria and testing protocols prior to product or service delivery.
• Specify traceability, labeling, and packaging requirements.
3. Documentation and Recordkeeping
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• Provide controlled documents detailing requirements for suppliers.
• Maintain records of communication exchanged with suppliers regarding specifications and agreements.
• Ensure external providers acknowledge receipt and understanding of requirements.
4. Ongoing Communication Framework
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• Establish protocols for changes, updates, or revisions to supplier requirements.
• Provide continuous feedback channels for supplier performance and issue resolution.
• Integrate supplier communication into overall QMS records for traceability.
Deliverables
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• Supplier requirements specification templates.
• Approved supplier communication checklist.
• Verification and acceptance criteria records.
• Documented supplier acknowledgment forms.
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 Requirements Communication Package | Standardized templates for communicating technical and quality requirements. | $1,400/system |
| Verification & Acceptance Criteria Toolkit | Tools and checklists for defining supplier verification and approval protocols. | $1,250/project |
| Controlled Document Framework for Suppliers | Document control templates tailored for external provider communications. | $1,600/system |
| Supplier Change Notification System | Structured framework for managing and documenting requirement updates. | $1,200/project |
