Provision of People

ISO 9001:2015 – Section 7.1.2

ISO 9001:2015 requires organizations to ensure that enough personnel with the necessary competence are available to implement, maintain, and continually improve the Quality Management System (QMS) and achieve product and service conformity.

Scope of Work

Our services for Clause 7.1.2 focus on ensuring your organization has the right people in the right roles to support QMS success:

1. Workforce Needs Assessment

  • • Identify personnel requirements based on QMS processes and objectives.

    • Review current staffing levels, roles, and competencies.

2. Role Definition and Allocation

  • • Define responsibilities for each position tied to QMS processes.

    • Establish clear accountability and reporting structures.

3. Competency Alignment

  • • Evaluate current personnel competencies against requirements.

    • Identify training or upskilling needs to close gaps.

4. Workforce Planning

  • • Create a plan for workforce adequacy to meet future organizational growth and QMS needs.

    • Establish periodic reviews of staffing effectiveness.

Deliverables

  • • Workforce requirements matrix.

    • Role descriptions with QMS-linked responsibilities.

    • Personnel competency evaluation reports.

    • Training or upskilling plan recommendations.

    • Workforce planning templates for ongoing 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 Basic review of workforce needs and personnel roles Starts at $12/hour
Standard Workforce competency evaluation and planning support Starts at $12/hour
Premium Comprehensive workforce development strategy and integration into QMS Custom Quote

Optional Add-On Services

Service Coverage Fee
Workforce Planning Workshop Facilitated session to align staffing needs with QMS objectives Starts at $12/hour
Competency Assessment Templates Templates for evaluating and recording personnel competency $12 per document
Resource Allocation Guidance Support for optimizing workforce allocation to QMS processes Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Workforce Needs Consultation
"Ensure your team has the people and skills to support QMS effectiveness and continual improvement."

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