Operational Planning and Control

ISO 9001:2015 – Section 8.1

ISO 9001:2015 requires organizations to plan, implement, and control processes needed to meet product and service requirements. This includes establishing criteria, resources, monitoring, and continual improvement practices to ensure conformity and customer satisfaction.

Scope of Work

Our services for Clause 8.1 focus on establishing structured operational control aligned with quality objectives:

1. Process Planning and Documentation

  • • Identify and define core operational processes.

    • Establish acceptance criteria for products and services.

    • Develop operational SOPs and work instructions.

2. Resource Allocation and Monitoring

  • • Determine required resources for operations.

    • Implement monitoring systems for process performance.

    • Define metrics and KPIs to evaluate operational effectiveness.

3. Control and Improvement

  • • Create methods for process validation and verification.

    • Establish corrective action triggers for operational deviations.

    • Support integration of continual improvement into operational workflows.

Deliverables

  • • Documented operational process maps.

    • Operational SOPs and acceptance criteria.

    • Monitoring and KPI tracking templates.

    • Corrective action response framework.

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 Investment
Starter Checklist of operational planning requirements + process mapping guidance Starts at $12/hour
Standard SOPs, acceptance criteria, and monitoring templates for selected processes Starts at $12/hour
Premium Full operational control system with KPIs, validation methods, and continual improvement integration Custom Quote

Optional Add-On Services

Service Coverage Fee
Process Mapping Workshop Interactive session to define and streamline processes Starts at $12/hour
KPI Development Toolkit Templates for monitoring and reporting process performance $12 per document
Operational Audit Support Review of operational planning and control effectiveness Custom Quote

Your Compliance Journey Starts Here

  • Book an Operational Planning Session
"Strong operations lead to consistent results—let’s structure your processes for success."

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