>
Recognizing the need
>
Decision to implement
>
Quality System Assessment-Gap Analysis
>
Executive Overview
| •
ISO
concepts and requirements • Definition of Quality Management System • Structure of the standards • Documentation requirements/control • Implementation/registration overview • Review status of current system to standards • Commitment to certification process • Establish steering committee • Select management representative • Draft Quality Policy and Objective |
>
Strategic Planning
| •
Determine scope of Quality Management System • Establish implementation schedule • Assignment of resources/responsibilities • Select implementation team • Select Internal Audit team |
>
Define Quality Management System
| • Process Mapping |
>
Training
| •
ISO employee orientation • ISO concepts and requirements • Production Managers & Supervisors • Frontline Personnel • Implementation Team |
>
Quality Management System Documentation Development
| •
Quality Policy • Quality Manual • System Procedures • System Instructions, Forms • Records • Master List |
>
Internal Audit Training & Program
| •
Program development/requirements • Audit objectives, planning/criteria • ISO concepts • Checklist development • Conducting Internal Audits • Post-audit surveillance |
>
Begin Implementation
| •
Test written procedures/instructions • Stabilization period • Conduct Internal Audits • Facilitate management reviews |
>
Select Registrar
| •
Implement Corrective & Preventive Action • Conduct Internal Audits |
>
Certification Preparation
| •
Readiness audit of system • Management review |
>
Certification Audit
| • Recommendation for certification |
