Organizational Knowledge

ISO 9001:2015 – Section 7.1.6

ISO 9001:2015 requires organizations to determine, maintain, and make available the knowledge necessary to ensure conformity of products and services. This includes knowledge gained internally (experience, lessons learned) and externally (standards, academic resources, industry best practices).

Scope of Work

Our services for Clause 7.1.6 focus on establishing a structured knowledge management framework:

1. Knowledge Identification

  • • Identify organizational knowledge critical for operations and QMS performance.

    • Map internal expertise, technical skills, and best practices.

2. Knowledge Capture and Documentation

  • • Develop processes to capture institutional knowledge from employees and external sources.

    • Create templates for documenting lessons learned, training guides, and reference materials.

3. Knowledge Maintenance and Accessibility

  • • Implement systems for updating and sharing knowledge (databases, document libraries).

    • Ensure critical information is easily accessible to relevant personnel.

4. Risk Management and Knowledge Gaps

  • • Assess risks associated with knowledge loss.

    • Create a plan to address gaps (cross-training, external resources).

Deliverables

  • • Organizational knowledge inventory and risk assessment report.

    • Knowledge management procedures and templates.

    • Knowledge retention and sharing strategy.

    • Recommendations for knowledge-based training programs.

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 Fee
Starter Knowledge gap checklist and basic inventory Starts at $12/hour
Standard Full knowledge management procedure setup and template creation Starts at $12/hour
Premium Fully customized knowledge management program with risk mitigation plans Custom Quote

Optional Add-On Services

Service Coverage Fee
Knowledge Capture Workshop Facilitation session with key personnel to capture undocumented expertise Starts at $12/hour
Knowledge Templates Package Templates for skills matrices, lessons learned logs, and knowledge sharing records $12 per document
Knowledge Management Audit Review of systems for knowledge accessibility and retention Custom Quote

Your Compliance Journey Starts Here

  • Book a Knowledge Management Review
"Knowledge is your organization’s backbone—let us help secure and grow it."

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