Production and Service Provision
ISO 9001:2015 – Section 8.5
Our consultancy approach ensures that organizations establish structured and controlled processes for production and service delivery. This guarantees that products and services meet customer requirements, comply with regulatory standards, and are consistently delivered under planned and monitored conditions.
Scope of Work
1. Controlled Process Conditions
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• Define and implement documented work instructions, procedures, and operational standards.
• Ensure availability and proper maintenance of resources, equipment, and infrastructure.
• Apply monitoring and measurement activities at relevant stages to ensure conformity.
2. Competency and Workforce Management
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• Assign qualified personnel with verified skills and competencies.
• Provide training and awareness sessions for employees engaged in production/service.
• Maintain documented evidence of qualifications, skills, and role assignments.
3. Identification, Traceability, and Documentation
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• Establish product/service identification methods during operations.
• Apply labeling, serial numbers, or batch/lot control for traceability.
• Keep records that demonstrate conformity and status of each product/service.
4. Customer and Regulatory Requirements
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• Incorporate customer-specific requirements into production/service controls.
• Address applicable regulatory and statutory standards relevant to the product/service.
• Ensure acceptance criteria are clearly defined and consistently applied.
5. Preservation and Delivery of Outputs
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• Define preservation methods (handling, packaging, storage, protection).
• Control post-delivery activities such as maintenance, servicing, or warranty obligations.
• Capture customer feedback post-delivery to inform continual improvement.
6. Nonconformity and Corrective Actions
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• Identify nonconforming outputs promptly and implement containment actions.
• Define corrective measures to prevent recurrence.
• Maintain records of actions taken and their effectiveness.
Deliverables
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• Documented production/service control framework.
• Competency and training records.
• Inspection and testing templates with acceptance criteria.
• Product/service traceability registers.
• Nonconformity and corrective action reports.
• Preservation and delivery process documentation.
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 |
|---|---|---|
| Operational Control Framework Package | Complete set of documented procedures, instructions, and monitoring templates. | $2,200/system |
| Competency & Training Management Toolkit | Templates and systems for managing qualifications, training, and role assignments. | $1,400/project |
| Identification & Traceability Package | Structured approach for labeling, tracking, and recording product/service status. | $1,600/system |
| Preservation & Delivery Protocol Kit | Tools for handling, packaging, storage, and post-delivery requirements. | $1,250/project |
| Nonconformity & Corrective Action Toolkit | Forms and registers for documenting and resolving process issues. | $1,050/project |
