Review of Requirements for Products and Services

ISO 9001:2015 – Section 8.2.3

Our consultancy ensures organizations implement a structured process to review customer, statutory, and regulatory requirements prior to acceptance. This helps prevent misunderstandings, ensures feasibility, and guarantees alignment with organizational capabilities and customer expectations.

Scope of Work

1. Pre-Contract Review

  • • Verify that all customer requirements (stated and implied) are clearly defined.

    • Ensure statutory and regulatory requirements are identified and addressed.

    • Confirm the organization has the capability and resources to meet commitments.

2. Feasibility and Risk Assessment

  • • Evaluate risks associated with meeting requirements (delivery, compliance, quality).

    • Conduct cross-functional reviews involving operations, quality, and management.

    • Provide documented risk assessments with mitigation actions.

3. Formal Review and Approval

  • • Establish standardized review checklists and forms.

    • Require documented evidence of review before contract acceptance.

    • Ensure top management approval for high-risk or high-value contracts.

4. Communication of Results

  • • Communicate review outcomes internally to all relevant personnel.

    • Confirm requirements with customers before proceeding with order execution.

    • Maintain traceable records of review decisions and approvals.

5. Handling Changes Post-Review

  • • Implement procedures for re-review in case of requirement modifications.

    • Ensure that changes are communicated to all affected functions.

    • Maintain updated records of requirement reviews, revisions, and approvals.

Deliverables

  • • Requirement review procedure and documented workflow.

    • Pre-contract review checklists and approval templates.

    • Feasibility and risk assessment reports.

    • Records of requirement reviews, decisions, and communications.

    • Change management log linked to requirement reviews.

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

Additional Compliance Support Options

Service Description Fee
Requirements Review Toolkit Checklists, forms, and process flows for systematic reviews. $1,350/project
Feasibility & Risk Assessment Package Comprehensive risk-based feasibility evaluation for contracts and orders. $1,850/system
Requirements Review Training Staff training to strengthen requirement verification and approval processes. $950/session
Change Control Integration Support Ongoing support for managing post-review changes in requirements. Starting at $120/month

  • • Context Analysis Workshop – $1,500/session

    Facilitate an interactive session to identify internal/external issues and stakeholder expectations.

    • Interested Parties Mapping & Register Setup – $1,200/project

    Create a structured register of interested parties, their requirements, and review protocols.

    • Risk & Opportunity Assessment Package – $2,800/system

    Comprehensive risk-based thinking integration aligned with ISO 9001 clauses 4.1 & 6.1.

    • Management Review Toolkit – $950

    Includes templates, KPIs, and guidance for effective leadership reviews.

    • Digital Compliance Templates Bundle – Starting at $99/month

    Ready-to-use ISO 9001 documentation templates with version control.

Your Compliance Journey Starts Here

  • Book a Free Consultation and Requirements Review Session
"Thorough reviews safeguard trust—let’s build a process that ensures clarity before commitment."

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