Monitoring, Measurement, Analysis and Evaluation

ISO 9001:2015 – Section 9.1

Our consultancy guides organizations in establishing effective monitoring and measurement practices to evaluate performance, ensure compliance with customer and regulatory requirements, and support evidence-based decision-making. This ensures that organizations can continually assess and improve their quality management system (QMS).

Scope of Work

1. Performance Metrics & Indicators

  • • Define key performance indicators (KPIs) linked to quality objectives.

    • Establish methods for measuring customer satisfaction and feedback.

    • Develop monitoring plans aligned with strategic goals.

2. Data Collection & Measurement Systems

  • • Implement systems for collecting accurate and reliable data.

    • Validate measurement tools and methods for consistency.

    • Ensure compliance with calibration and verification requirements.

3. Analysis & Interpretation

  • • Apply statistical and analytical techniques to identify trends.

    • Compare performance against objectives and benchmarks.

    • Highlight areas of risk, inefficiency, and opportunity.

4. Evaluation & Reporting

  • • Generate reports that provide clear insights into QMS performance.

    • Provide evidence of conformity to customer, statutory, and regulatory requirements.

    • Use evaluation outcomes to drive continual improvement initiatives.

Deliverables

  • • Defined set of KPIs and measurement methods.

    • Customer satisfaction and feedback analysis reports.

    • Data collection and monitoring templates.

    • QMS performance dashboards.

    • Periodic evaluation and management reports.

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
KPI & Metrics Framework Structured framework for defining and tracking QMS-related performance indicators. $1,500/system
Customer Feedback Analysis Package Tools and reporting systems for gathering and analyzing customer satisfaction data. $1,200/project
Data & Trend Analysis Toolkit Templates and methods for evaluating performance data and identifying trends. $950/project
Digital QMS Monitoring Dashboard Cloud-based solution for real-time monitoring and reporting. 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 & Measurement Readiness Session
"What gets measured gets improved—let’s build the evidence base for your quality journey."

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