Preservation

ISO 9001:2015 – Section 8.5.4

Our consultancy supports organizations in establishing effective preservation methods for products and services throughout production and delivery. Preservation ensures that conformity is maintained from initial processing to final delivery, safeguarding product integrity, customer satisfaction, and compliance with ISO 9001:2015.

Scope of Work

1. Preservation Requirements

  • • Identify preservation needs based on product characteristics and customer requirements.

    • Define methods for handling, packaging, storage, and delivery.

    • Establish environmental controls (temperature, humidity, protection from contamination).

2. Handling and Packaging Controls

  • • Develop standardized handling procedures to prevent damage or deterioration.

    • Define packaging specifications aligned with product sensitivity and transport requirements.

    • Apply labeling for identification, traceability, and special handling instructions.

3. Storage and Protection Measures

  • • Implement storage protocols ensuring safe, controlled environments.

    • Introduce inventory management systems to prevent obsolescence or misuse.

    • Define segregation requirements for different materials or conditions.

4. Preservation During Service Provision

  • • Apply measures to maintain service quality during execution and delivery.

    • Monitor conditions that could impact service delivery or customer satisfaction.

    • Document preservation activities as part of operational records.

Deliverables

  • • Preservation and handling procedures.

    • Packaging and labeling specifications.

    • Storage control checklist and logs.

    • Environmental monitoring records.

    • Evidence of preservation throughout service provision.

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

Additional Compliance Support Options

Service Description Fee
Preservation & Handling Toolkit Includes preservation SOPs, checklists, and monitoring forms. $1,400/project
Controlled Storage Setup Design and implementation of storage control measures with monitoring. $2,200/system
Packaging Standards Development Customized packaging and labeling requirements aligned with ISO 9001. $1,600/project
Digital Preservation Monitoring Cloud-based tools for tracking preservation activities and environmental data. Starting at $120/month

  • • Context Analysis Workshop – $1,500/session

    Facilitate an interactive session to identify internal/external issues and stakeholder expectations.

    • Interested Parties Mapping & Register Setup – $1,200/project

    Create a structured register of interested parties, their requirements, and review protocols.

    • Risk & Opportunity Assessment Package – $2,800/system

    Comprehensive risk-based thinking integration aligned with ISO 9001 clauses 4.1 & 6.1.

    • Management Review Toolkit – $950

    Includes templates, KPIs, and guidance for effective leadership reviews.

    • Digital Compliance Templates Bundle – Starting at $99/month

    Ready-to-use ISO 9001 documentation templates with version control.

Your Compliance Journey Starts Here

  • Book a Free Consultation and Preservation Review
"Preservation safeguards quality—ensuring products and services arrive exactly as intended."

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