Release of Products and Services

ISO 9001:2015 – Section 8.6

Our consultancy ensures that organizations establish structured processes for verifying that all products and services meet defined requirements before release. This clause emphasizes documented evidence of conformity, clear authority for release, and maintaining customer confidence by preventing nonconforming outputs from reaching the market.

Scope of Work

1. Release Criteria Definition

  • • Establish acceptance criteria for products and services prior to delivery.

    • Define checkpoints, inspections, and required approvals.

    • Ensure alignment with customer, statutory, and regulatory requirements.

2. Verification & Validation

  • • Conduct planned inspections, tests, and reviews to confirm conformity.

    • Implement sampling plans and quality assurance protocols.

    • Record objective evidence of verification results.

3. Authorization of Release

  • • Assign responsibility and authority for approving product/service release.

    • Use documented sign-offs or digital approval workflows.

    • Ensure no release occurs without meeting acceptance requirements.

4. Recordkeeping & Traceability

  • • Maintain records of verification, approval, and release authorization.

    • Ensure traceability of released products and services to responsible personnel.

    • Store evidence in accordance with documented information controls.

Deliverables

  • • Release and approval procedures.

    • Inspection and test records.

    • Acceptance criteria checklists.

    • Release authorization forms/sign-off logs.

    • Traceability and verification reports.

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
Release Procedure Development Complete documentation for release controls with checklists and approval records. $1,400/system
Product & Service Verification Toolkit Includes test forms, inspection templates, and acceptance criteria samples. $1,200/project
Authority & Responsibility Mapping Clarifies approval roles for product/service release. $950/session
Digital Release Records Setup Cloud-based verification and approval documentation system. 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 Release Control Readiness Session
"Assurance before delivery—because customer trust begins with verified quality."

GET STARTED NOW
×