Determining the Requirements for Products and Services

ISO 9001:2015 – Section 8.2.2

Our consultancy approach ensures organizations establish robust processes to determine and review requirements for products and services. This prevents misunderstandings, strengthens customer confidence, and guarantees that delivered outputs meet expectations, legal obligations, and industry standards.

Scope of Work

1. Requirement Identification

  • • Identify stated customer requirements, including product/service specifications, delivery terms, and quality expectations.

    • Capture implied needs not explicitly stated but necessary for intended use.

    • Integrate statutory and regulatory requirements into the requirement framework.

2. Feasibility and Capability Analysis

  • • Assess organizational ability to meet customer and regulatory requirements.

    • Conduct resource and capacity planning before committing to supply.

    • Provide documented feasibility evaluations with risk considerations.

3. Requirements Documentation and Review

  • • Develop standardized forms and checklists for requirement capture.

    • Review requirements for completeness, clarity, and consistency before acceptance.

    • Ensure alignment between customer requirements and organizational objectives.

4. Changes to Requirements

  • • Establish a documented process for handling changes to requirements.

    • Ensure all revisions are communicated, reviewed, and approved before implementation.

    • Maintain records of requirement changes and their impact assessments.

Deliverables

  • • Requirement determination procedure and documented process flow.

    • Requirement capture templates and feasibility checklists.

    • Records of requirement reviews and approvals.

    • Change management log for requirement modifications.

    • Compliance mapping against customer, statutory, and regulatory needs.

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 Capture Toolkit Templates and guidance for gathering complete customer, legal, and regulatory requirements. $1,400/project
Feasibility Assessment Package Structured evaluation of capability, capacity, and resource sufficiency. $1,650/system
Requirements Change Control Framework Documented procedures and tools for managing requirement modifications. $1,200/project
Regulatory & Standards Alignment Support Updates and integration of evolving statutory/industry requirements. Starting at $99/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 Determination Workshop
"Clear requirements lead to consistent outcomes—let’s align your processes to ensure customer and regulatory confidence."

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