ISO9001 Toolkit Version 3
AREA
DOC REF
DOCUMENT
All
All
All
00. Implementation Resources
None None None None None QMS-DOC-00-1 QMS-DOC-00-2 QMS-DOC-00-3 QMS-DOC-00-4 QMS-FORM-00-1 QMS-FORM-00-2 QMS-FORM-00-3 QMS-FORM-00-4
CERTIKIT Completion Instructions CERTIKIT ISO9001 Toolkit v3 Implementation Guide CERTIKIT ISO9001 Toolkit v3 Index CERTIKIT ISO9001 Toolkit v3 Release Notes CERTIKIT Standard Licence Terms Quality Management System PID ISO9001 QMS Presentation ISO9001 Project Plan ISO9001 Project Plan Project Kick-off Meeting Agenda ISO9001 Assessment Evidence ISO9001 Progress Report ISO9001 Gap Assessment Tool
01-03. Scope, Normative References, Terms and Definitions
None
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04. Context of the Organization
QMS-DOC-04-1
QMS Context, Requirements and Scope
05. Leadership
None QMS-DOC-05-1 QMS-DOC-05-2 QMS-DOC-05-3 QMS-DOC-05-4 QMS-DOC-05-5 QMS-DOC-05-6 QMS-DOC-05-7 QMS-FORM-05-1
EXAMPLE Statutory and Regulatory Requirements Quality Policy Quality Manual QMS Roles Responsibilities and Authorities Top Management Communication Program Executive Support Letter Statutory and Regulatory Requirements Procedure Statutory and Regulatory Requirements Meeting Minutes Template
06. Planning
None QMS-DOC-06-1 QMS-DOC-06-2 QMS-DOC-06-3 QMS-DOC-06-4 QMS-FORM-06-1
EXAMPLE Risk and Opportunity Assessment Tool Quality Management Plan Risk and Opportunity Assessment Process Risk and Opportunity Assessment Report Risk and Opportunity Action Plan Risk and Opportunity Assessment Tool
07. Support
None None None QMS-DOC-07-1 QMS-DOC-07-2 QMS-DOC-07-3 QMS-DOC-07-4 QMS-DOC-07-5 QMS-DOC-07-6 QMS-DOC-07-7 QMS-DOC-07-8 QMS-FORM-07-1 QMS-FORM-07-2
EXAMPLE Asset Maintenance Register and Schedule EXAMPLE Competence Development Questionnaire ISO9001 Quality Poster Procedure for the Control of Documented Information QMS Documentation Log Competence Development Procedure Competence Development Report Quality Management Awareness Presentation Quality Communication Plan Organizational Knowledge Management Policy Procedure for the Maintenance of Assets Competence Development Questionnaire Asset Maintenance Register and Schedule
08. Operation
QMS-DOC-08-1 QMS-DOC-08-2 QMS-DOC-08-3 QMS-DOC-08-4 QMS-DOC-08-5
Requirements Process Design and Development Process External Provider Management Process Production and Service Provision Process Standard Operating Procedure
09. Performance Evaluation
None None QMS-DOC-09-1 QMS-DOC-09-2 QMS-DOC-09-3 QMS-DOC-09-4 QMS-DOC-09-5 QMS-FORM-09-1 QMS-FORM-09-2 QMS-FORM-09-3 QMS-FORM-09-4 QMS-FORM-09-5
EXAMPLE Customer Satisfaction Questionnaire EXAMPLE Internal Audit Action Plan Process for Monitoring Measurement Analysis and Evaluation Procedure for Internal Audits Internal Audit Plan Procedure for Management Reviews Internal Audit Report Internal Audit Schedule Internal Audit Action Plan Management Review Meeting Agenda Internal Audit Checklist Customer Satisfaction Questionnaire
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10. Improvement
None QMS-DOC-10-1 QMS-FORM-10-1
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EXAMPLE Nonconformity and Corrective Action Log Procedure for the Management of Nonconformity Nonconformity and Corrective Action Log