Awareness

ISO 9001:2015 – Section 7.3

ISO 9001:2015 requires organizations to ensure that employees are aware of their role in the QMS, its importance, and how their work contributes to quality objectives. This clause emphasizes communication and engagement at every level.

Scope of Work

Our services for Clause 7.3 focus on improving employee awareness and ownership of quality responsibilities:

1. Awareness Program Development

  • • Identify awareness needs by role and department.

    • Design structured awareness initiatives to ensure employees understand QMS requirements.

2. Communication of Quality Policy and Objectives

  • • Develop materials to communicate the organization’s quality policy, objectives, and expectations.

    • Create role-specific messaging to connect employee tasks with QMS goals.

3. Awareness Training Sessions

  • • Conduct interactive workshops or training sessions to explain QMS relevance.

    • Reinforce the importance of meeting customer and regulatory requirements.

4. Documentation of Awareness Activities

  • • Provide templates to record attendance, participation, and feedback.

    • Ensure documentation is audit-ready.

Deliverables

  • • Awareness plan tailored to organizational needs.

    • Role-based communication materials.

    • Training slide decks and handouts.

    • Templates for awareness session records and evaluations.

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 Awareness checklist review and basic communication plan Starts at $12/hour
Standard Role-based awareness program with communication tools and training guides Starts at $12/hour
Premium Full customization with training delivery, leadership coaching, and audit prep Custom Quote

Optional Add-On Services

Service Coverage Fee
Awareness Training Delivery Interactive training sessions to build employee engagement Starts at $12/hour
Communication Toolkit Posters, handouts, and visual aids for awareness campaigns $12 per document
Audit Readiness Review Detailed review of awareness documentation and practices Custom Quote

Your Compliance Journey Starts Here

  • Book an Awareness Program Planning Session
"Awareness builds ownership; equip your team to uphold quality."

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