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Document Reference |
Tittle |
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00. Implementation Resources |
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DOWNLOADABLE LIST OF DOCUMENTS IN THE TOOLKIT |
2 pages |
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A Guide to Implementing the ISO9001 Standard |
30 pages |
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ISO9001 Toolkit Completion Instructions |
5 pages |
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QMS-DOC-00-1 |
Quality Management System PID |
19 pages |
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QMS-DOC-00-2 |
ISO9001 QMS Presentation |
8 slides |
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QMS-DOC-00-3 |
ISO9001 Project Plan (Microsoft Project format) |
1 plan |
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QMS-DOC-00-4 |
ISO9001 Project Plan (Microsoft Excel format) |
1 tab |
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QMS-FORM-00-1 |
Project Kickoff Meeting Agenda |
2 pages |
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QMS-FORM-00-2 |
ISO9001 Assessment Evidence |
1 tab |
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QMS-FORM-00-3 |
ISO9001 Progress Report |
2 pages |
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QMS-FORM-00-4 |
ISO9001 Gap Assessment Tool |
10 tabs |
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01-03. Scope, Normative References, Terms and Definitions |
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No documents are required by the standard in these sections |
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04. Context of the Organization |
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QMS-DOC-04-1 |
QMS Context, Requirements and Scope |
20 pages |
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05. Leadership |
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QMS-DOC-05-1 |
Quality Policy |
12 pages |
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QMS-DOC-05-2 |
Quality Manual |
11 pages |
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QMS-DOC-05-3 |
QMS Roles Responsibilities and Authorities |
16 pages |
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QMS-DOC-05-4 |
Top Management Communication Program |
9 pages |
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QMS-DOC-05-5 |
Executive Support Letter |
5 pages |
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QMS-DOC-05-6 |
Statutory and Regulatory Requirements Procedure |
12 pages |
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QMS-DOC-05-7 |
Statutory and Regulatory Requirements |
1 tab |
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QMS-FORM-05-1 |
Meeting Minutes Template |
1 page |
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EXAMPLE Statutory and Regulatory Requirements |
1 tab |
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Statutory and Regulatory Requirements Procedure (Visio) |
1 chart |
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06. Planning |
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QMS-DOC-06-1 |
Quality Management Plan |
16 pages |
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QMS-DOC-06-2 |
Risk and Opportunity Assessment Process |
21 pages |
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QMS-DOC-06-3 |
Risk and Opportunity Assessment Report |
14 pages |
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QMS-DOC-06-4 |
Risk and Opportunity Action Plan |
11 pages |
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QMS-FORM-06-1 |
Risk and Opportunity Assessment Tool |
7 tabs |
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Risk and Opportunity Assessment Process (Visio) |
1 chart |
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Risk and Opportunity Classification Matrix (Visio) |
1 chart |
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07. Support |
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QMS-DOC-07-1 |
Procedure for the Control of Documented Information |
16 pages |
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QMS-DOC-07-2 |
QMS Documentation Log |
1 tab |
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QMS-DOC-07-3 |
Competence Development Procedure |
15 pages |
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QMS-DOC-07-4 |
Competence Development Report |
13 pages |
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QMS-DOC-07-5 |
Quality Management Awareness Presentation |
12 slides |
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QMS-DOC-07-6 |
Quality Communication Plan |
10 pages |
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QMS-FORM-07-1 |
Competence Development Questionnaire |
2 tabs |
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EXAMPLE Competence Development Questionnaire |
2 tabs |
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Document Control Process Diagram (Visio) |
1 chart |
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08. Operation |
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QMS-DOC-08-1 |
Requirements Process |
17 pages |
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QMS-DOC-08-2 |
Design and Development Process |
16 pages |
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QMS-DOC-08-3 |
External Provider Management Process |
16 pages |
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QMS-DOC-08-4 |
Production and Service Provision Process |
17 pages |
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Design and Development Process (Visio) |
1 chart |
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External Provider Management Process (Visio) |
1 chart |
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Production and Service Provision Process (Visio) |
1 chart |
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Requirements Process (Visio) |
1 chart |
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09. Performance Evaluation |
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QMS-DOC-09-1 |
Process for Monitoring Measurement Analysis and Evaluation |
13 pages |
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QMS-DOC-09-2 |
Procedure for Internal Audits |
10 pages |
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QMS-DOC-09-3 |
Internal Audit Plan |
10 pages |
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QMS-DOC-09-4 |
Procedure for Management Reviews |
13 pages |
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QMS-DOC-09-5 |
Internal Audit Report |
15 pages |
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QMS-FORM-09-1 |
Internal Audit Schedule |
2 pages |
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QMS-FORM-09-2 |
Internal Audit Action Plan |
1 page |
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QMS-FORM-09-3 |
Management Review Meeting Agenda |
6 pages |
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QMS-FORM-09-4 |
Internal Audit Checklist |
16 pages |
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Process for Monitoring Measurement Analysis and Evaluation (Visio) |
1 chart |
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10. Improvement |
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QMS-DOC-10-1 |
Procedure for the Management of Nonconformity |
11 pages |
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QMS-FORM-10-1 |
Nonconformity and Corrective Action Log |
3 tabs |
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EXAMPLE Nonconformity and Corrective Action Log |
3 tabs |
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Nonconformity Management Process (Visio) |
1 chart |