Requirements for Products and Services

ISO 9001:2015 – Section 8.2

ISO 9001:2015 requires organizations to establish processes for determining, reviewing, and communicating requirements for products and services. This ensures that customer and regulatory requirements are properly understood, documented, and met.

Scope of Work

Our services for Clause 8.2 focus on ensuring accurate capture and management of customer requirements:

1. Requirements Identification

  • • Collect customer, regulatory, and statutory requirements.

    • Translate requirements into documented specifications.

    • Establish criteria for acceptance and compliance.

2. Requirement Review and Validation

  • • Review requirements for clarity, completeness, and feasibility.

    • Validate requirements against organizational capabilities.

    • Establish change management procedures for requirement updates.

3. Customer and Stakeholder Communication

  • • Implement methods to capture ongoing customer feedback.

    • Establish documented communication channels (email, portals, records).

    • Ensure traceability of requirement changes and acknowledgments.

Deliverables

  • • Requirements capture and validation templates.

    • Customer requirement review procedure.

    • Change request and approval forms.

    • Requirement traceability matrix.

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 for capturing and documenting customer requirements Starts at $12/hour
Standard Requirement review procedure + templates for validation and change requests Starts at $12/hour
Premium Comprehensive requirements management system with traceability matrix and stakeholder validation Custom Quote

Optional Add-On Services

Service Coverage Fee
Requirements Workshop Facilitate session with key stakeholders to define requirements Starts at $12/hour
Requirement Traceability Toolkit Templates for tracking requirements across the process lifecycle $12 per document
Customer Communication Audit Evaluate effectiveness of requirement communication channels Custom Quote

Your Compliance Journey Starts Here

  • Book a Requirements Management Session
"Clear requirements lead to quality results—let’s define them right."

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