Frequently Asked Questions About ISO 9000
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Q: What Software is Available to help with ISO 9000
A: No software package, regardless of how sophisticated it is, can do
the work of designing, creating and maintaining an ISO 9001 conformant quality
management system. None-the less, several
software packages are now available that can help automate some aspects of your
management system. Here is an annotated list (That is still under construction!).
ISO9 provides a fully automated
web based solution for organizations implementing ISO 9001. Contact them at 1433
Webster Street, Oakland, CA 94612. Phone 1.866.321.4769, Fax 509.357.8673.
QMS/9000+ is an integrated suite of 23 computer software Modules which execute
procedural, record keeping and reporting tasks needed to address ISO/QS-9000
QMS/9000+ is available from John A. Keane &
Associates, Inc., 273 Jefferson Road, Princeton, NJ 08540 609-924-7904
fax:609-924-1078 E-mail: email@example.com
The ISO 9000 Quality System
Checklist contains the materials that are needed to establish and maintain an ISO 9000
auditing program. It is formatted as a 3 ring binder/218 pages plus 2 diskettes for use
with Microsoft Word 6.0 for Windows and Microsoft Excel 4.0a for Windows or later versions
of Microsoft products.
The ASSESSOR for ISO 9000
The Assessor for ISO 9000 is a Windows based software tool that can help develop your own
ISO 9000 road map. Determine if you really need ISO 9000, or to what classification you
should be certified. The Assessor will educate you and provide a customized approach.
Global QA has released a package called the ISO 9000 USA.COM program. It is
an ISO 9001:2000 Combined, Software, Consulting and Training package for the development
and implementation of an ISO 9001:2000 Quality System.
iSO-Pro For Windows -- A Toolkit for
ISO 9000 Certification. Using iSO-Pro, a company can learn about ISO 9000, compare their
current quality position to the standard, track important project milestone dates and
develop materials to support ISO compliance.
IBS offers enterprise-wide shop floor
control and quality management software for ISO-9000/14000, ISO/TS-16949:2002
and FDA 21 CFR Part 11standards. IBS is an ISO-9001 registered company.
Inc. -- Workflow management, provides workflow management and
To The Point Consulting
provides companies with software that complies with the new ISO 9001: 2000
ISO 9000:2000 Quality
Manual System, from Bizmanuals.com.
A program called QUALIMETRIX is available from ALD USA, 320 W. 37th Street, #12A New
York, NY 10018 Phone 212-594-6600
QMS/CIM is an ISO/QS-9000 compliant Virtual Factory which models a real factory with
ISO/QS-9000 certification. Using the latest simulation technology, QMS/CIM enables
students to interactively manage an ISO/QS-9000 compliant plant at the desktop. Planners
can "test drive" different quality systems before committing real dollars. Three
versions are available
A free version of CIM Quality can be downloaded from John A. Keane & Associates, Inc., 595 Ewing St.
Princeton, NJ 08540 609-924-7904 fax:609-924-1078 E-mail: firstname.lastname@example.org
Documented quality management system
Process documents are typically written using popular word processing programs that are
generally available. Some specialized systems are also available.
- Zavanta is knowledgebase software that helps subject experts capture and
communicate processes, procedures, work instructions and organizational
policies and distribute them electronically via the web or intranet. Zavanta
and its predecessor ProcedureWRITE has helped hundreds of organizations
capture, manage, and standardize the documentation required for ISO 9000
registration in half the time it would normally take using tools with a word
processing front end. A free demo is available from
- Procedure Design makes the task of documenting
procedures efficient and effective through its front end flowcharting and on-line
documenting capability. It comes with an integrated database which stores linkages between
all elements of a flowchart, with its associated descriptive text. MS Word documents are
produced automatically through templates, which are customizable. With the stored and
reusable data, the user is building up a 'living' Corporate Database.
Organizations may with to analyze their processes using process mapping
before writing or revising process documentation. Process mapping software
It is helpful to include flowcharts in the process documents. Flowcharting software
- ISOlutioner is a business process
mapping tool. Pre-developed templates simplify process map creation for
documenting the Quality Management System.
- iGrafx® FlowCharter from iGrafix, inc.
- SmartDraw comes with special templates and shape
libraries for ISO 9000 Flow Charts, Process Flow Diagrams, Engineering Diagrams, Circuit
diagrams, Floor Plans, Organizational Charts, Business Forms, Network Design, Timelines
and much more. Automatic "connector objects" intelligently link shapes into
perfect diagrams, and SmartDraw's "snap to grid" and other alignment features
make neat, crisp drawings literally a "snap." SmartDraw works with MS Office and
other programs, making it easy to transfer your drawings into your other documents. Users
can download a sample copy.
- Corel Flow from Corel Corporation, 1600 Carling
Avenue, Ottawa Canada. Phone 613-728-8200. E-mail email@example.com
- Visio, now from Microsoft.
- TeamFlow from CFM Inc. 60 The Great Road, Bedford, MA
01730. Phone 800-647-1708. A demo version
is available. Or contact them via E-mail at: firstname.lastname@example.org
- Process Charter for Windows from Business Solutions Group, Scitor Corporation, 333 Middlefield Road, Second Floor,
Menlo Park, CA 94025. Phone 800-549-9876 or 415-462-4200. E-mail to email@example.com
- EtQ Maps - Process Map Templates for ISO-9000, from
EtQ Management Consultants,
- TopDown FlowCharter from Kaetron
There are some products available that provide "quick start" templates for
creating quality manuals or process documents. They include:
- ISO'Logic Forms from O'Logic, PO Box 4711,
Englewood Colorado 80155 Phone 1-800-956-4423
- The five-title CD-ROM collection "The ISO 9000 Registration Series". The
series is a comprehensive multimedia training toolkit for Windows PCs. It is designed to
guide an organization through all the steps to registration, and includes electronic tools
for generating a Quality manual and associated SOPs. Each title covers a different phase
of preparing for registration, from the initial executive briefing through documentation
and internal auditing. A free Demo CD-ROM is available for review. Contact Reality Interactive at 11200 West 78th St. Suite 300,
Eden Prairie, MN 55344. Phone (800) 675-7789.
Also see the comments on Document Control, below.
Control of Documents:
Several companies have reported success in using distributed electronic documentation
systems, such as:
Policy & Procedure Manager™ is a tool from
Policy Technologies for helping
organizations stay on top of their policy and procedure process.
- Adobe Systems FrameMaker
and FrameViewer products,
- Microsoft Help, as a framework for managing their
- QualDoc is an automated document control package
which is designed to comply with the requirements of the ISO 9000 series of standards.
- QDMS is a windows based Drawing and Transmittal Managment
System which is available from to QA
- Master Control software for electronic routing and approval from Document Control Systems, 302 W. 5400 South Ste
101, Salt Lake City, UT 84107. Phone (801) 281-8366.
- Document Control System Software by the Warrenton Group
- The Document & Training Management System is a Windows based system that helps
businesses manage documents and then tracks training against those documents. It is
available from: Quality Systems Integrators.
- Trove for Manuals - Trove for
Manuals is a software package designed to reduce the effort and expense of maintaining and
distributing large, structured documents, manuals or procedures.
- QualTrax - QualTrax is an on-line,
Intranet-based, software package that helps firms improve and effectively manage their
internal documents from company-wide phone lists and employee manuals, to operating
procedures and work instructions, to equipment guidelines and safety policies.
- DocBase Direct is a web-based
ISO9001:2000 compliant document management application requiring no
installation of hardware or software. It securely controls and organizes
documents in any software format allowing customizable workflow and electronic
signatures. Phone: 866-354-0300 (US), 570-524-2785 (international), E-mail:
- ProTrack is a supplier quality tracking system available from American Quality Systems, PO Box
618, Howell, MI 48844. Phone 800-776-3090 and fax 800-776-3096.
Control of production and service provision
Unisoft Corporation offers
OneFACTORY, a computer integrated manufacturing (CIM) factory automation
software suite for the electronics manufacturing industry. Contact them at: 116a
Research Dr. Milford, CT 06460 Call: 1-888-486-4246, Fax: 1-888-329-4246. Or
E-mail to: firstname.lastname@example.org
Control of monitoring and measurement devices
- The web based Corrective Action Tracking System (CATS web) from
- Customer Focused Quality is a software
application used to record and track customer complaints and internal corrective action.
- Customer Expressions provides
i-Sight: a web based system to record, manage and learn from complaints
and corrective actions.
Monitoring and measurement
Many software packages to assist in Statistical Process Control (SPC) are available.
Some assist with customer satisfaction measurement, such as the following: