ISO 9001:2008 TEMPLATE DOCUMENTATION
Quality Manual, 26 Operational Procedures and 18 Forms
5th Edition — 52 MS Word files
Purchase  $290
Thousands of Certified Companies Since 1992
Originally published in 1992, this was the first commercial template documentation for ISO 9001. Now in its fifth edition, and with 18,000 copies sold, it has helped thousands of companies to achieve ISO 9001 registration. It is by far the most popular and proven package on the market.
This documentation defines a quality system that is simple, intuitive, and free from excessive paperwork, making it easy to operate and maintain. Although simple and streamlined, it is a complete quality system that fully complies with ISO 9001:2008. Several sample documents are included in the PDF files in the sidebar. To view more documents and how they can be integrated into the ISOXpress software, download free trial.
Implementation Tutorial
The implementation tutorial helps you edit and customize the documentation to fit your company. It comes in the form of extensive notes and tips inserted directly into the documents. These notes:
  • Identify and explain the requirements which are being addressed in the particular section of the document,
  • Alert you to sections where you may need to make changes, and
  • Discuss alternative approaches and solutions that may be more suitable for particular industries or types of companies.
It is like having a consultant by your side, anticipating your questions and helping you in real time as you customize the documentation.
List of Documents
Quality Manual
SECTION 0 - INDEX AND REVISION STATUS
SECTION 1 - SCOPE
1.1   Quality Policy
1.2   Introduction
1.3   Application
1.4   Exclusions
SECTION 2 - REFERENCE DOCUMENTS
SECTION 3 - TERMS AND DEFINITIONS
SECTION 4 - QUALITY MANAGEMENT SYSTEM
4.1   Quality System Processes
4.2   Documentation and Records
SECTION 5 - MANAGEMENT RESPONSIBILITY
5.1   Management Commitment
5.2   Customer Focus
5.3   Quality Policy
5.4   Quality System Planning
5.5   Organization and Communication
5.6   Management Review
SECTION 6 - RESOURCE MANAGEMENT
6.1   Provision of Resources
6.2   Competence, Awareness and Training
6.3   Infrastructure
6.4   Work Environment
SECTION 7 - PRODUCT REALIZATION
7.1   Planning of Product Realization
7.2   Customer-related Processes
7.3   Design Control
7.4   Purchasing
7.5   Operations
7.6   Monitoring and Measuring Equipment
SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1   Planning of Monitoring and Measurement
8.2   Monitoring and Measurement
8.3   Control of Nonconforming Product
8.4   Analysis of Data
8.5   Continual Improvement
   
Operational Procedures
QOP-42-01   Control of Documents
QOP-42-02   Control of Records
QOP-56-01   Management Review
QOP-62-01   Competence, Awareness and Training
QOP-63-01   Equipment Maintenance
QOP-71-01   Planning of Product Realization
QOP-72-01   Order Processing and Review
QOP-73-01   Design Control
QOP-74-01   Supplier Evaluation and Monitoring
QOP-74-02   Purchasing
QOP-74-03   Verification of Purchased Product
QOP-75-01   Work Order and Production Records
QOP-75-02   Validation of Processes
QOP-75-03   Work Instructions
QOP-75-04   Product Identification and Traceability
QOP-75-05   Storage, Handling and Preservation
QOP-75-06   Packaging and Shipping
QOP-76-01   Measuring and Monitoring Devices
QOP-82-01   Customer Satisfaction
QOP-82-02   Internal Quality Audits
QOP-82-03   In-process Inspections
QOP-82-04   Final Inspection
QOP-83-01   Control of Nonconforming Product
QOP-85-01   Continual Improvement
QOP-85-02   Customer Complaints
QOP-85-03   Corrective and Preventive Action
   
Forms
QF-42-01-1   Document Control Master List
QF-56-01-1   Management Review Report
QF-62-01-1   Personnel Competency Matrix
QF-62-01-2   Training Record
QF-62-01-3   Personnel Competency Certification
QF-73-01-1   Design Project Plan and Schedule
QF-73-01-2   Design Review Report
QF-73-01-3   Engineering Change Notice (ECN)
QF-74-01-1   Approved Supplier List
QF-74-01-2   Supplier Certification
QF-75-01-1   Production Work Order
QF-76-01-1   Measuring Device Log
QF-82-02-1   Internal Audit Plan
QF-82-02-2   Audit Nonconformity Report
QF-82-02-3   Internal Audit Checklist
QF-83-01-1   Product Nonconformity Report (PNR)
QF-85-02-1   Customer Complaint Report
QF-85-03-1   Corrective Action Request (CAR)
 
Sample pages Quality Manual
Sample Procedures
To view more documents and how they can be integrated into the ISOXpress software, download free trial.
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