Competence

ISO 9001:2015 – Section 7.2

ISO 9001:2015 requires organizations to ensure that employees are competent based on education, training, and experience. This clause emphasizes determining competency requirements, addressing gaps, and maintaining appropriate records.

Scope of Work

Our services for Clause 7.2 focus on ensuring your workforce meets QMS competency needs:

1. Competency Requirements Identification

  • • Define roles and responsibilities for all QMS-related activities.

    • Establish required qualifications, training, and experience per role.

2. Competency Evaluation

  • • Assess current employee qualifications and experience against role requirements.

    • Identify skill and knowledge gaps.

3. Competency Development

  • • Recommend training programs, mentoring, or cross-training initiatives.

    • Create a competency development plan to address identified gaps.

4. Competency Records Management

  • • Develop forms and templates to document competency evidence.

    • Maintain training logs, certifications, and evaluation records.

Deliverables

  • • Competency matrix mapping roles to requirements.

    • Skills gap analysis report.

    • Competency development plan.

    • Training and evaluation record templates.

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 Competency checklist review and basic matrix Starts at $12/hour
Standard Full competency analysis, role-based evaluations, and gap identification Starts at $12/hour
Premium Full customization with training plans, audit preparation, and system setup Custom Quote

Optional Add-On Services

Service Coverage Fee
Training Plan Design Tailored plan for employee training and skills development Starts at $12/hour
Competency Record Templates Forms and templates for recording training and qualifications $12 per document
Competency Verification Audit Detailed review of employee qualifications for audit readiness Custom Quote

Your Compliance Journey Starts Here

  • Book a Competency Gap Assessment
"Empower your team—competence drives quality."

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