ISOXpress ISO 9001 Document Control and Quality Management Software: Template Documentation

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ISO 9001:2008 TEMPLATE DOCUMENTATION
Quality Manual, 26 Operational Procedures and 23 Forms

Free Sample Documents

This template documentation consists of an 8-section Quality Manual, 26 Operational Procedures, 18 electronic forms, and 5 manual forms (list of documents). Here are a few sample documents (in the ISOXpress software all documents are available in editable MS Word files):

	Quality Manual QM-00 Index		Operational Procedure QOP-56-01 Management Review
	Quality Manual QM-01 Scope		Operational Procedure QOP-82-02 Internal Quality Audits
	Quality Manual QM-06 Resource Management

To see how this documentation is managed and controlled in the ISOXpress system watch the Quick Tour slide show or download the 30-day Free Trial.

Thousands of Certified Companies

Originally published in 1992, this documentation was the first commercial template for ISO 9001 in the USA. 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 (list of documents) that fully complies with ISO 9001:2008. Several sample documents are included in the MS Word files above. To view more documents and to see how they can be integrated into the ISOXpress software, download the free trial of the software.

Implementation Tutorial

The implementation tutorial (illustrated in the picture below) 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.
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

Manual Forms (printable, manual forms)
QF-73-01-1	Design Project Plan and Schedule
QF-73-01-2	Design Review Report
QF-73-01-3	Engineering Change Notice
QF-75-01-1	Production Work Order
QF-82-02-1	Internal Audit Checklist

Electronic Forms (data entry forms in ISOXpress software)
ER-42-01-1	Document Control Record (ISOXpress Document Control module)
ER-56-01-1	Management Review Record (ISOXpress Management Review module)
ER-56-01-2	Quality Objective/Target Record (ISOXpress Management Review module)
ER-62-01-1	Training Program Record (ISOXpress Training module)
ER-62-01-2	Training Event Record (ISOXpress Training module)
ER-62-01-3	Competency Certification Program Record (ISOXpress Training module)
ER-62-01-4	Competency Certification Record (ISOXpress Training module)
ER-62-01-5	Personnel Training/Competency Record (ISOXpress Training module)
ER-74-01-1	Supplier Control Record (ISOXpress Supplier Control module)
ER-74-01-2	Supplier Nonconformity Record (ISOXpress Supplier Control module)
ER-74-01-3	Supplier Corrective Action Request Record (ISOXpress Supplier Control module)
ER-76-01-1	Measuring Equipment Record (ISOXpress Measuring Equipment module)
ER-82-02-1	Internal Audit Record (ISOXpress Internal Audit module)
ER-82-02-2	Internal Audit Plan Record (ISOXpress Internal Audit module)
ER-82-02-3	Internal Audit Finding Record (ISOXpress Internal Audit module)
ER-83-01-1	Nonconforming (NC) Product Record (ISOXpress Nonconforming Product module)
ER-85-02-1	Customer Complaint Record (ISOXpress Customer Complaints module)
ER-85-03-1	Corrective/Preventive Action Record (ISOXpress Corrective Action module)

Related products


	ISO 9001 Complete Starter Package ISOXpress Software Template Documentation Internal Audit Checklist Employee Training ISO 9001 Compliance Guide

	ISOXpress ISO 9001 System Software Document Control and ISO System Management

	ISOXpress Combined ISO 9001+14001 System Software

Quick FAQs

When I purchase the Complete Starter Package, will this documentation be already pre-loaded into the ISOXpress software?
Yes, all the documents will already be pre-loaded in to the ISOXpress Document Control module.
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.


Products	Support	Customer Support		Other Systems
ISOXpress Software	Online Store	Customer Feedback	Purchase Orders	ISO 9001
Starter Package	Downloads	Return Guarantee	International Orders	ISO 14001
Template Documentation	Support Center	Support Policy	About AQA Co.	ISO 9001+14001
Internal Audit Checklist	Support Policy	Privacy Policy	Contact AQA Co.	ISO 13485
Employee Training		Satisfied Customers		ISO 14971
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