Management Review – General

ISO 9001:2015 – Section 9.3.1

Our consultancy approach supports organizations in establishing structured management reviews to ensure the continuing suitability, adequacy, effectiveness, and alignment of the Quality Management System (QMS) with strategic direction.

Scope of Work

1. Establishing Review Framework

  • • Define management review objectives in line with ISO 9001:2015.

    • Ensure reviews cover overall QMS performance and continual improvement opportunities.

    • Align review activities with the organization’s business strategy.

2. Integration into Business Processes

  • • Incorporate management review into regular business planning cycles.

    • Ensure leadership accountability and active participation.

    • Document evidence of review to demonstrate compliance.

3. Continual Improvement Focus

  • • Identify areas of improvement and corrective action needs.

    • Promote risk-based thinking in decision-making.

    • Align review outcomes with customer satisfaction and organizational goals.

Deliverables

  • • Management review framework and procedures.

    • Documented evidence templates for review sessions.

    • Reporting format for outcomes and follow-up actions.

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

Additional Compliance Support Options

Service Description Fee
Management Review Framework Setup Tailored review structures aligned with ISO requirements. $1,400/system
Leadership Engagement Workshop Facilitation for leadership teams to strengthen review practices. $1,100/session
Performance Monitoring Dashboard Real-time tracking tool for QMS performance and review inputs. Starting at $99/month

  • • Context Analysis Workshop – $1,500/session

    Facilitate an interactive session to identify internal/external issues and stakeholder expectations.

    • Interested Parties Mapping & Register Setup – $1,200/project

    Create a structured register of interested parties, their requirements, and review protocols.

    • Risk & Opportunity Assessment Package – $2,800/system

    Comprehensive risk-based thinking integration aligned with ISO 9001 clauses 4.1 & 6.1.

    • Management Review Toolkit – $950

    Includes templates, KPIs, and guidance for effective leadership reviews.

    • Digital Compliance Templates Bundle – Starting at $99/month

    Ready-to-use ISO 9001 documentation templates with version control.

Your Compliance Journey Starts Here

  • Book a Free Consultation and Review Framework Readiness Check
"Effective reviews drive effective systems—let’s strengthen leadership oversight in your QMS."

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