Monitoring, Measurement, Analysis and Evaluation – General

ISO 9001:2015 – Section 9.1.1

Our consultancy approach ensures organizations establish a systematic framework for monitoring, measurement, analysis, and evaluation to provide evidence of conformity, assess QMS effectiveness, and support continual improvement.

Scope of Work

1. Determining What to Monitor and Measure

  • • Identify processes, outputs, and quality objectives requiring monitoring.

    • Define criteria for conformity and performance evaluation.

    • Align monitoring needs with customer and regulatory requirements.

2. Methods and Tools

  • • Select appropriate measurement and analysis methods.

    • Validate tools and ensure accuracy of measurement systems.

    • Integrate digital and manual monitoring techniques.

3. Frequency and Responsibility

  • • Establish monitoring schedules and review intervals.

    • Assign responsibilities for data collection and evaluation.

    • Ensure timely communication of results to decision-makers.

4. Evaluation and Use of Results

  • • Compare performance against planned objectives and benchmarks.

    • Provide data-driven insights for decision-making and improvement.

    • Document results for management reviews and compliance reporting.

Deliverables

  • • Monitoring and measurement plan with defined scope, methods, and frequency.

    • Documented performance evaluation framework.

    • Assigned responsibility matrix for monitoring activities.

    • Reports demonstrating conformity and system effectiveness.

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
Monitoring & Measurement Framework Comprehensive setup of what to measure, how, and when. $1,400/system
Evaluation Reporting Toolkit Templates and guidance for performance evaluation reports. $950/project
Digital Monitoring Dashboard Real-time monitoring and evaluation platform for QMS data. 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 Monitoring Readiness Assessment
"Strong decisions come from strong evidence—let’s build your QMS evaluation framework."

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