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ISO 9001:2008 TEMPLATE DOCUMENTATION
Quality Manual, 26 Operational Procedures and 18 Forms
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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.
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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.
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List of Documents
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Quality Manual
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SECTION 0 - INDEX AND REVISION STATUS |
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SECTION 1 - SCOPE |
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1.1 |
Quality Policy |
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1.2 |
Introduction |
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1.3 |
Application |
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1.4 |
Exclusions |
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SECTION 2 - REFERENCE DOCUMENTS
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SECTION 3 - TERMS AND DEFINITIONS |
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SECTION 4 - QUALITY MANAGEMENT SYSTEM |
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4.1 |
Quality System Processes
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4.2 |
Documentation and Records |
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SECTION 5 - MANAGEMENT RESPONSIBILITY |
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5.1 |
Management Commitment |
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5.2 |
Customer Focus |
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5.3 |
Quality Policy |
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5.4 |
Quality System Planning |
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5.5 |
Organization and Communication |
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5.6 |
Management Review |
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SECTION 6 - RESOURCE MANAGEMENT |
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6.1 |
Provision of Resources |
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6.2 |
Competence, Awareness and Training |
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6.3 |
Infrastructure |
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6.4 |
Work Environment |
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SECTION 7 - PRODUCT REALIZATION |
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7.1 |
Planning of Product Realization |
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7.2 |
Customer-related Processes |
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7.3 |
Design Control |
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7.4 |
Purchasing |
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7.5 |
Operations |
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7.6 |
Monitoring and Measuring Equipment |
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SECTION 8 - MEASUREMENT, ANALYSIS AND IMPROVEMENT |
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8.1 |
Planning of Monitoring and Measurement |
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8.2 |
Monitoring and Measurement |
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8.3 |
Control of Nonconforming Product |
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8.4 |
Analysis of Data |
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8.5 |
Continual Improvement |
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Operational Procedures |
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QOP-42-01 |
Control of Documents |
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QOP-42-02 |
Control of Records |
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QOP-56-01 |
Management Review |
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QOP-62-01 |
Competence, Awareness and Training |
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QOP-63-01 |
Equipment Maintenance |
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QOP-71-01 |
Planning of Product Realization
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QOP-72-01 |
Order Processing and Review |
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QOP-73-01 |
Design Control |
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QOP-74-01 |
Supplier Evaluation and Monitoring |
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QOP-74-02 |
Purchasing |
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QOP-74-03 |
Verification of Purchased Product |
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QOP-75-01 |
Work Order and Production Records |
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QOP-75-02 |
Validation of Processes
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QOP-75-03 |
Work Instructions |
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QOP-75-04 |
Product Identification and Traceability |
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QOP-75-05 |
Storage, Handling and Preservation |
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QOP-75-06 |
Packaging and Shipping |
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QOP-76-01 |
Measuring and Monitoring Devices |
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QOP-82-01 |
Customer Satisfaction |
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QOP-82-02 |
Internal Quality Audits |
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QOP-82-03 |
In-process Inspections |
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QOP-82-04 |
Final Inspection |
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QOP-83-01 |
Control of Nonconforming Product |
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QOP-85-01 |
Continual Improvement
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QOP-85-02 |
Customer Complaints |
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QOP-85-03 |
Corrective and Preventive Action |
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Forms
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QF-42-01-1 |
Document Control Master List |
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QF-56-01-1 |
Management Review Report |
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QF-62-01-1 |
Personnel Competency Matrix
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QF-62-01-2 |
Training Record |
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QF-62-01-3 |
Personnel Competency Certification |
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QF-73-01-1 |
Design Project Plan and Schedule |
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QF-73-01-2 |
Design Review Report |
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QF-73-01-3 |
Engineering Change Notice (ECN) |
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QF-74-01-1 |
Approved Supplier List |
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QF-74-01-2 |
Supplier Certification |
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QF-75-01-1 |
Production Work Order |
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QF-76-01-1 |
Measuring Device Log |
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QF-82-02-1 |
Internal Audit Plan |
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QF-82-02-2 |
Audit Nonconformity Report |
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QF-82-02-3 |
Internal Audit Checklist |
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QF-83-01-1 |
Product Nonconformity Report (PNR) |
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QF-85-02-1 |
Customer Complaint Report |
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QF-85-03-1 |
Corrective Action Request (CAR) |
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Quick FAQs
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- Is this documentation the same as the
one preloaded into the ISOXpress software and offered in the 'Complete Package'?
The manual and procedures are the same, but the forms are different. In this package
the forms are MS Word and/or Excel files, while in the ISOXpress integrated version most
forms are superseded by ISO Manager modules.
- Is there a discount when I buy this
documentation integrated with the ISOXpress software?
Yes, you save $347 when you purchase the 'Complete System' package, which includes this
documentation, the ISOXpress software, and three other products.
- Can I return the template documentation
and get my money back?
Template Documentation cannot be returned because it consists of MS Word files that
cannot be protected against copying. Before you buy, check out the examples in the PDF files above or, even
better,
download free trial.
- How do I take the Implementation Tutorial
out of the text?
As you are editing the documents, just delete the blue italic paragraphs before
saving the document. There is no automated way to do it.
- Can I get help with customizing this
documentation to fit my company?
Help with editing the documentation requires consulting time, and is not included
in the price of the package. However, if you just have a quick question, please
call us at 626-796-9000 and we should be able to give you a quick answer. The Implementation Tutorial
will give you a lot of help as you go through the documents.
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