Actions to Address Risks and Opportunities

ISO 9001:2015 – Section 6.1

ISO 9001:2015 requires organizations to determine, plan, and implement actions to address risks and opportunities that can affect the QMS’s ability to achieve its intended results, enhance desirable effects, and prevent undesired outcomes.

Scope of Work

Our services for Clause 6.1 focus on building a structured risk and opportunity management process:

1. Risk and Opportunity Identification

  • • Review internal and external factors (from Clause 4.1 context analysis) to identify potential risks and opportunities.

    • Evaluate process-level risks linked to quality objectives, compliance, and customer satisfaction.

2. Risk Assessment and Prioritization

  • • Develop criteria for risk rating (likelihood, severity, detection).

    • Create a risk register with assigned owners and review timelines.

3. Planning of Actions

  • • Recommend mitigation and enhancement strategies.

    • Link risk and opportunity actions to strategic objectives and operational processes.

4. Integration with QMS

  • • Align risk-based thinking with decision-making processes.

    • Define controls and monitoring procedures for risk-based actions.

5. Review and Improvement

  • • Provide guidance for periodic review and updates of risk and opportunity plans.

Deliverables

  • • Comprehensive risk and opportunity register.

    • Risk assessment methodology with criteria and scoring system.

    • Action plan template linking risks/opportunities to QMS objectives.

    • Recommendations for integration into processes and audits.

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 risk checklist and simple action plan Starts at $12/hour
Standard Full risk register, prioritization, and integration guidance Starts at $12/hour
Premium Complete risk management framework, facilitation workshop, custom scoring system Custom Quote

Optional Add-On Services

Service Coverage Fee
Risk Management Workshop Facilitated session to identify, assess, and plan actions Starts at $12/hour
Risk Register Template Structured tool for risk/opportunity management $12 per document
Integration Support Assistance in embedding risk-based thinking across QMS Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Risk & Opportunity Planning Session
"Proactive risk-based thinking ensures your QMS is resilient, effective, and ISO 9001:2015 compliant.""

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