Organizational Roles, Responsibilities, and Authorities

ISO 9001:2015 – Section 5.3

ISO 9001:2015 requires the organization to define, communicate, and assign responsibilities and authorities to ensure effective operation of the QMS and achievement of quality objectives.

Scope of Work

Our services for Clause 5.3 focus on clearly defining roles and responsibilities within the QMS:

1. Roles Identification

  • • Review current organizational structure and key positions.

    • Identify all roles required for QMS implementation and maintenance.

2. Responsibilities Assignment

  • • Define specific responsibilities for each role in line with ISO 9001:2015 requirements.

    • Ensure responsibilities cover process ownership, quality objectives, compliance, and continual improvement.

3. Authorities Definition

  • • Assign decision-making authority for QMS activities.

    • Ensure clarity of escalation procedures and reporting lines.

4. Documentation and Communication

  • • Document roles, responsibilities, and authorities in a structured format.

    • Develop communication plan to ensure all personnel understand their roles and authorities.

5. Monitoring and Updates

  • • Recommend mechanisms to review and update roles periodically.

    • Provide tools to track compliance with assigned responsibilities and authorities.

Deliverables

  • • Organizational roles and responsibilities report.

    • Authority matrix linking decisions to responsible roles.

    • Communication plan and acknowledgement templates.

    • Recommendations for ongoing review and updates of roles and authorities.

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 roles/responsibilities checklist and documentation Starts at $12/hour
Standard Full roles/responsibilities mapping, authority assignment, communication guidance Starts at $12/hour
Premium Complete organizational structure review, leadership facilitation, oversight templates Custom Quote

Optional Add-On Services

Service Coverage Fee
Roles & Responsibilities Workshop Interactive session to finalize and communicate roles Starts at $12/hour
Authority Matrix Template Ready-to-use template for documenting responsibilities and authorities $12 per document

Your Compliance Journey Starts Here

  • Book a Free Organizational Roles Alignment Session
"Clear roles, responsibilities, and authorities ensure your QMS operates effectively and meets ISO 9001 standards."

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