Documented Information – Control of Documented Information

ISO 9001:2015 – Section 7.5.3

This sub-clause requires that documented information is protected, available, and properly controlled to prevent unauthorized access or use.

Scope of Work

1. Develop procedures for document distribution, storage, and retrieval.

2. Establish controls for access, confidentiality, and security.

3. Define methods for archiving obsolete documents.

4. Train staff on document control responsibilities.

3. Retention and Disposition Management

  • • Define retention times based on statutory, regulatory, and organizational needs.

    • Establish proper procedures for secure archiving.

    • Implement safe disposal methods for obsolete or redundant information.

Deliverables

  • • Document control procedure.

    • Access control matrix.

    • Obsolete document archiving process.

    • Training materials for document custodians.

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 document access and retention control Starts at $12/hour
Standard Document control SOP + archiving system Starts at $12/hour
Premium Custom digital document control solution with security protocols Custom Quote

Optional Add-On Services

Service Coverage Fee
Access Control Register Role-based permissions documentation $12 per document
Archiving Toolkit Templates for managing obsolete documentation $12 per document
Digital Control Integration Setup of document control in e-QMS software Custom Quote

Your Compliance Journey Starts Here

  • Book a Document Control Implementation Session
"Control ensures reliability—manage your documents the right way."

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