Improvement – General

ISO 9001:2015 – Section 10.1

Our consultancy approach ensures that organizations establish a structured framework for identifying and implementing improvements. These improvements strengthen the effectiveness of the QMS, enhance customer satisfaction, and ensure that risks and opportunities are continually addressed.

Scope of Work

1. Improvement Identification

  • • Establish mechanisms for capturing opportunities for improvement from audits, customer feedback, performance monitoring, and risk assessments.

    • Evaluate opportunities for strategic, operational, and compliance-driven improvements.

2. Implementation and Integration

  • • Define processes for prioritizing and implementing improvements.

    • Integrate improvement actions into business planning and operational control.

    • Monitor effectiveness through performance indicators and management review.

3. Continual Improvement Culture

  • • Develop awareness programs to embed continual improvement into organizational culture.

    • Provide tools for departments to independently identify and act on improvement needs.

    • Encourage innovation while maintaining compliance with ISO 9001 standards.

Deliverables

  • • Improvement opportunity register.

    • Implementation and tracking framework.

    • Reports and templates for monitoring improvement 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
Improvement Register Setup Comprehensive system for documenting, prioritizing, and tracking improvements. $950/project
Performance & Improvement Monitoring Toolkit Tools for measuring the impact of improvement initiatives. $1,250/system
Continual Improvement Training Workshops to foster proactive identification of improvement opportunities. $1,100/session

  • • 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 Improvement Planning Session
"Continual improvement is not optional—it’s the heartbeat of quality management."

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