Documented Information – Creating and Updating

ISO 9001:2015 – Section 7.5.2

This sub-clause requires proper formatting, review, and approval of documents before release, and updates when necessary.

Scope of Work

1. Develop procedures for creating, reviewing, and approving documents.

2. Establish formatting rules (titles, codes, revision levels).

3. Define approval authorities for controlled documents.

4. Provide templates for document approval and change logs.

3. Revision and Update Management

  • • Define procedures for revising documents as processes evolve.

    • Apply change control measures to prevent unauthorized or outdated versions.

    • Communicate updates to all relevant personnel in a timely manner.

Deliverables

  • • Document creation and approval SOP.

    • Standard formatting guidelines.

    • Approval and change control forms.

    • Document revision log template.

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 Document approval workflow checklist Starts at $12/hour
Standard SOP + templates for document creation and change logs Starts at $12/hour
Premium Customized document lifecycle management program Custom Quote

Optional Add-On Services

Service Coverage Fee
Change Management Support Guidance on updating existing documents Starts at $12/hour
Document Formatting Templates Pre-designed word/excel templates $12 per document
Lifecycle Integration Custom workflow mapping for document changes Custom Quote

Your Compliance Journey Starts Here

  • Book a Document Control Setup Session
"Consistency starts with proper creation and approval."

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