Documented Information

ISO 9001:2015 – Section 7.5

ISO 9001:2015 requires organizations to establish, implement, and maintain documented information to support the QMS and demonstrate conformity to requirements. This overarching clause covers creation, control, and maintenance of documents and records.

Scope of Work

Our services for Clause 7.5 focus on ensuring a compliant documentation framework:

1. Identify required documented information as per ISO 9001:2015.

2. Develop or review policies, SOPs, forms, and records aligned with QMS needs.

3. Establish documentation structure (manual, procedures, records).

4. Provide guidance on digital or paper-based control systems.

7. Audit and Certification Readiness

  • • Prepare documented information for third-party audits and certifications.

    • Provide evidence of document control, record retention, and version management.

    • Support corrective actions for gaps in documentation practices.

Deliverables

  • • Documentation framework outline.

    • Document hierarchy structure (policy → procedure → form → record).

    • Sample templates for core QMS documentation.

    • Recommendations for digital documentation tools (if applicable).

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 of required QMS documents and basic framework guidance Starts at $12/hour
Standard Full documentation framework with sample templates Starts at $12/hour
Premium Custom-built documentation system integrated with risk-based thinking and digital tools Custom Quote

Optional Add-On Services

Service Coverage Fee
Document Library Setup Create ready-to-use template repository $12 per document
Digital Documentation Integration Guidance on electronic QMS platforms Custom Quote
Documentation Audit Support Review of documentation control for certification audits Custom Quote

Your Compliance Journey Starts Here

  • Book a Documentation Framework Session
"Strong systems need strong documentation—let’s build yours right."

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