Establishing the Quality Policy

ISO 9001:2015 – Section 5.2.1

ISO 9001:2015 requires the organization’s top management to establish a quality policy that aligns with strategic direction, supports quality objectives, and demonstrates commitment to customer satisfaction and continual improvement.

Scope of Work

Our services for Clause 5.2.1 focus on the creation and formal establishment of a compliant quality policy:

1. Drafting the Quality Policy

  • • Develop policy reflecting organizational purpose and strategic direction.

    • Ensure the policy includes commitments to customer requirements, compliance, and continual improvement.

    • Review policy wording for clarity and applicability across the organization.

2. Leadership Review and Approval

  • • Facilitate leadership review sessions.

    • Document approval and adoption process.

    • Provide guidance to ensure top management visibly endorses the policy.

3. Integration with QMS

  • • Map the policy to QMS processes and objectives.

    • Recommend practical steps for implementation within daily operations.

4. Monitoring & Update Planning

  • • Establish a process for periodic review and updates.

    • Provide guidance for tracking policy effectiveness over time.

Deliverables

  • • Drafted and ISO 9001:2015-compliant quality policy.

    • Leadership approval record and adoption documentation.

    • Policy-to-QMS process mapping report.

    • Recommendations for monitoring and periodic review.

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 Review existing policy and provide recommendations Starts at $12/hour
Standard Draft new policy, map to QMS processes, leadership guidance Starts at $12/hour
Premium Full policy creation, leadership approval facilitation, integration, monitoring plan Custom Quote

Optional Add-On Services

Service Coverage Fee
Policy Establishment Workshop Session with leadership to finalize and approve policy Starts at $12/hour
Policy Template Ready-to-use quality policy template $12 per document

Your Compliance Journey Starts Here

  • Book a Free Quality Policy Establishment Session
"A well-established quality policy ensures alignment, accountability, and continual improvement."

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