Quality Objectives and Planning to Achieve Them

ISO 9001:2015 – Section 6.2

ISO 9001:2015 requires organizations to establish measurable quality objectives at relevant functions, levels, and processes. Objectives must be consistent with the quality policy and planned to drive continual improvement.

Scope of Work

Our services for Clause 6.2 ensure quality objectives are clear, measurable, and actionable:

1. Objective Setting and Alignment

  • • Identify key quality objectives aligned with customer needs, strategic goals, and compliance requirements.

    • Ensure objectives are measurable and consistent with the quality policy.

2. Planning to Achieve Objectives

  • • Define responsible personnel, timelines, and required resources for each objective.

    • Establish metrics and performance indicators for monitoring progress.

3. Documentation and Integration

  • • Create a formal Quality Objectives Register.

    • Link objectives to processes, risks, and opportunities (Clause 6.1).

4. Monitoring and Review Process

  • • Set review intervals and reporting requirements.

    • Provide recommendations for continual improvement based on performance data.

Deliverables

  • • Documented Quality Objectives Register.

    • Plans for achieving each quality objective (resources, roles, and metrics).

    • Templates for periodic review and updates.

    • Recommendations for integration into management reviews 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 Review of existing objectives and basic documentation support Starts at $12/hour
Standard Full development of objectives, metrics, and planning tools Starts at $12/hour
Premium Comprehensive integration with risk, process, and audit planning Custom Quote

Optional Add-On Services

Service Coverage Fee
Objective-Setting Workshop Facilitated session with leadership to define measurable objectives Starts at $12/hour
KPI Dashboard Template Simple visual tracking tool for objective performance $12 per document
Performance Analysis Support Guidance for analyzing and improving performance trends Starts at $12/hour

Your Compliance Journey Starts Here

  • Book a Free Consultation to Build Measurable Quality Objectives
"Clear objectives drive improvement, compliance, and customer satisfaction."

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