Quality Management System and Its Processes

ISO 9001:2015 – Section 4.4

ISO 9001:2015 Clause 4.4 requires organizations to establish, implement, maintain, and continually improve a Quality Management System (QMS) including its processes. This ensures effective operations, compliance, and continual improvement across all organizational activities.

Scope of Work

Our services under Clause 4.4 focus on defining, mapping, and documenting your QMS processes:

1. Process Identification and Mapping

  • • Identify all core and supporting processes within the QMS.

    • Define inputs, outputs, responsibilities, and interactions between processes.

2. Process Documentation

  • • Draft or customize Standard Operating Procedures (SOPs), work instructions, and process maps.

    • Ensure process documentation aligns with ISO 9001:2015 requirements.

3. Performance Metrics & Monitoring

  • • Establish key performance indicators (KPIs) for each process.

    • Define monitoring methods and data collection for process effectiveness.

4. Integration & Control

  • • Implement procedures for process ownership, responsibilities, and authority.

    • Develop methods to integrate processes into the broader QMS framework.

5. Continuous Improvement & Risk Integration

  • • Link process performance to risk and opportunity management (Clause 6.1).

    • Provide recommendations for continual improvement and audit readiness.

Deliverables

  • • Process mapping documentation.

    • SOPs, work instructions, and templates for QMS processes.

    • Defined KPIs and monitoring methods for process effectiveness.

    • Integration guidance to align processes within the QMS framework.

    • Recommendations for continual improvement initiatives.

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 Package • Review and mapping of key processes.
• Basic SOP templates. 		Starts at $12 per hour
Standard Package • Full process mapping and documentation.
• Work instructions and process templates.
• KPIs for selected processes. 		Starts at $12 per hour
Premium Package • Comprehensive process-based QMS setup.
• Integration of all QMS processes with risk and performance monitoring.
• Leadership workshop for process validation.
• Full audit-ready documentation. 		Custom Quote

Optional Add-On Services

Service Coverage Fee
Process Mapping Workshop Interactive session to validate and optimize QMS processes. Starts at $12 per hour
Full SOP Development Drafting or customizing all process SOPs and work instructions. Custom Quote
Annual Process Review Scheduled review to ensure ongoing effectiveness and compliance. Starts at $12 per hour

Your Compliance Journey Starts Here

  • Book a Free Process Mapping and QMS Alignment Session
"Effective processes drive quality—let us help you build a QMS that works for your organization and auditors alike."

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