Planning of Changes

ISO 9001:2015 – Section 6.3

ISO 9001:2015 requires organizations to plan and manage changes to the QMS systematically. Changes should be evaluated for risks, resources, and potential impacts on product quality and compliance.

Scope of Work

Our services for Clause 6.3 focus on building a structured process for managing QMS changes:

1. Change Identification and Documentation

  • • Establish a process to log all proposed changes to the QMS.

    • Define change types (process, resource, documentation, etc.).

2. Risk and Impact Assessment

  • • Assess risks, potential effects, and dependencies of proposed changes.

    • Evaluate required resources and roles for implementing changes.

3. Planning and Approval Process

  • • Develop workflows for planning, reviewing, and approving changes.

    • Create change request forms and approval templates.

4. Implementation Support

  • • Provide guidance on implementing approved changes with minimal disruption.

    • Ensure necessary training, communication, and documentation updates.

5. Review and Continuous Improvement

  • • Define monitoring requirements and review intervals for effectiveness of changes.

    • Support root-cause analysis for major change-related issues.

Deliverables

  • • Documented change management procedure.

    • Change request and approval templates.

    • Risk and impact analysis tools for changes.

    • Recommendations for integrating change planning with strategic decisions.

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 change log and simple approval workflow Starts at $12/hour
Standard Full change management procedure and risk-based planning Starts at $12/hour
Premium Customized setup, with comprehensive system integration and workflow automation Custom Quote

Optional Add-On Services

Service Coverage Fee
Change Management Workshop Facilitated session to design a robust change process Starts at $12/hour
Change Log Template Digital-ready template for tracking and approvals $12 per document
Implementation Support Guidance on major QMS changes, training, and audits Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Change Planning Consultation
"Planned changes minimize risks and ensure QMS stability while supporting growth."

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