Documented Information – General

ISO 9001:2015 – Section 7.5.1

This sub-clause specifies that documented information must be created and maintained to support the QMS, while also retaining records as evidence of conformity.

Scope of Work

1. Identify documents needed for effective QMS operation.

2. Review existing documentation for compliance gaps.

3. Ensure retention requirements are defined for key records.

4. Align documented information with ISO 9001 clauses and customer requirements.

3. Evidence of Conformity and Effectiveness

  • • Define records that demonstrate performance and compliance.

    • Ensure records are complete, accurate, and traceable.

    • Provide guidance on retention and accessibility of documented evidence.

Deliverables

  • • Document register draft.

    • Gap analysis of existing documentation.

    • Retention schedule template.

    • Draft list of required records per clause.

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 register and retention schedule checklist Starts at $12/hour
Standard Gap analysis + draft register with retention guidance Starts at $12/hour
Premium Customized document and record management plan with stakeholder validation Custom Quote

Optional Add-On Services

Service Coverage Fee
Document Gap Audit Full review of existing documentation Custom Quote
Retention Schedule Setup Build detailed record retention system $12 per document
Integration Support Align document needs with digital systems Custom Quote

Your Compliance Journey Starts Here

  • Book a Documentation Needs Assessment
"Identify, retain, and maintain—the essentials of compliance."

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