Provision of Infrastructure

ISO 9001:2015 – Section 7.1.3

ISO 9001:2015 requires organizations to determine, provide, and maintain the infrastructure necessary for the operation of processes and to achieve conformity of products and services. Infrastructure includes buildings, workspace, utilities, equipment, IT systems, and supporting services.

Scope of Work

Our services for Clause 7.1.3 focus on helping your organization ensure adequate infrastructure to meet QMS requirements:

1. Infrastructure Needs Assessment

  • • Identify all infrastructure components (facilities, utilities, process equipment, IT systems) necessary to achieve product and service conformity.

    • Assess current infrastructure capacity, condition, and adequacy.

2. Infrastructure Documentation

  • • Document key infrastructure elements supporting QMS processes.

    • Create a register of equipment, facilities, and supporting systems.

3. Maintenance and Support Planning

  • • Establish processes for maintaining and upgrading infrastructure.

    • Define maintenance intervals, ownership, and monitoring methods.

4. Risk and Compliance Review

  • • Identify risks tied to infrastructure failures or inadequacies.

    • Recommend mitigation strategies and contingency planning.

Deliverables

  • • Infrastructure assessment and adequacy report.

    • Infrastructure and equipment register template.

    • Documented infrastructure maintenance plan.

    • Risk assessment report with recommendations for improvement.

Pricing & Timeline

  • • 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

  • • On-site or remote audit-day presence

    • Real-time response to auditor inquiries

    • Post-audit support and non-conformance response drafting

Deliverables:

  • ✓ Audit Representation

    ✓ NC Response Support

    ✓ Audit Day Documentation

Project Closure

  • • Final FSMS documentation handover

    • Executive summary outlining system status and sustainability plan

    • Option to transition into maintenance & continuous improvement support

Deliverables:

  • ✓ Final Document Handover

    ✓ Close-Out Report

    ✓ Maintenance Plan Proposal

Service Packages & Pricing

Package Coverage Fee
Starter Basic infrastructure checklist and register template Starts at $12/hour
Standard Full infrastructure assessment, documentation, and maintenance plan Starts at $12/hour
Premium Comprehensive infrastructure optimization strategy with risk analysis Custom Quote

Optional Add-On Services

Service Coverage Fee
Infrastructure Audit Workshop Onsite or virtual session to review infrastructure adequacy and risks Starts at $12/hour
Equipment & Facility Register Detailed, digital-ready documentation template $12 per document
Maintenance Program Guidance Support in implementing preventive maintenance schedules Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Infrastructure Assessment Consultation
"A well-documented and maintained infrastructure is the foundation for QMS performance and compliance."

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