Leadership and Commitment – General

ISO 9001:2015 – Section 5.1.1

ISO 9001:2015 requires top management to demonstrate general accountability for the QMS, ensuring it achieves intended outcomes and integrates into organizational strategy.

Scope of Work

Our services for Clause 5.1.1 focus on establishing leadership accountability:

1. Leadership Accountability Assessment

  • • Document top management roles and responsibilities regarding QMS performance.

    • Review current engagement in internal audits and quality reviews.

2. Integration with Strategy

  • • Map QMS objectives to strategic and operational plans.

    • Identify gaps in oversight and strategic alignment.

3. Continual Improvement Facilitation

  • • Recommend leadership-driven improvement initiatives.

    • Facilitate corrective action planning involving management.

Deliverables

  • • Leadership accountability report.

    • QMS integration map linking objectives to business strategy.

    • Recommendations for continual improvement initiatives.

    • Templates for tracking leadership actions and improvements.

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 Leadership accountability checklist Starts at $12/hour
Standard Integration mapping, improvement recommendations Starts at $12/hour
Premium Full leadership engagement plan, oversight documentation, continual improvement plan Custom Quote

Optional Add-On Services

Service Coverage Fee
Leadership Oversight Workshop Interactive session to review accountability and responsibilities Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Leadership Accountability Session
"Ensure top management is fully responsible for QMS effectiveness and continual improvement."

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