Provision of Monitoring and Measuring Resources
ISO 9001:2015 – Section 7.1.5
ISO 9001:2015 requires organizations to determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring quality. This includes equipment calibration, verification, maintenance, and traceability to international or national standards.
Scope of Work
Our services for Clause 7.1.5 focus on establishing a robust framework for managing monitoring and measuring resources:
1. Resource Identification and Planning
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• Identify all devices and resources used for monitoring and measurement.
• Determine calibration or verification requirements based on industry standards.
2. Calibration and Verification Program
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• Develop procedures for calibration, verification, and adjustment of equipment.
• Ensure traceability of measurements to recognized standards.
3. Record Management
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• Implement a system for recording calibration, verification, and maintenance activities.
• Create templates for calibration certificates and logs.
4. Risk Management and Compliance Review
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• Assess risks associated with inaccurate measurements or equipment failure.
• Conduct compliance reviews against ISO 9001:2015 and regulatory requirements.
Deliverables
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• Equipment inventory and classification report.
• Calibration and verification procedure documents.
• Monitoring and measurement schedule and logs.
• Risk assessment and compliance improvement plan.
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
Service Packages & Pricing
| Package | Coverage | Fee |
|---|---|---|
| Starter | Basic calibration and verification checklist | Starts at $12/hour |
| Standard | Full setup of monitoring and measurement resource system | Starts at $12/hour |
| Premium | Complete calibration program with traceability documentation and full customization | Custom Quote |
Optional Add-On Services
| Service | Coverage | Fee |
|---|---|---|
| Calibration Workshop | Training on calibration/verification best practices | Starts at $12/hour |
| Calibration Records Templates | Templates for logs, certificates, and schedules | $12 per document |
| Internal Audit Prep | Pre-audit review of calibration systems | Custom Quote |
