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Now upgraded to ISO 9001:2000 edition, this
template documentation package helped thousands of companies to
achieve ISO 9001 registration. No. 1 since 1992.
- Fully developed generic documentation with
everything you need for ISO 9001 certification, including quality
manual, procedures and forms. (list of documents)
- Complete Internal Audit Checklist (for process approach) incl. specific questions and auditing
techniques for each QMS process and ISO 9001 requirement (PDF sample).
- A quality system that is simple, intuitive, and free from excessive paperwork; and thus
easy to operate and maintain.
- Unparalleled record of successfully passed certification audits reported by
40,000 satisfied customers (all systems).
- MS Word formatted
documents, forms and templates. (You can use any other document
format as well.)
- Tutorial
to help you edit and implement the documents to fit your company.
- ISO Organizer softwarefor organizing
the quality system documentation and records.
Now in its fourth edition, and with 12,000
copies sold, this is by far the most popular package on the market.
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You can also purchase this
documentation bundled with
the XISOX ISO Manager -- a Web-based or Intranet software for
managing document distribution, document control, corrective
and preventive actions, internal audits, management reviews,
training, and nonconforming products -- and receive a $200 discount.
(link to XISOX.com site) |
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| DEMO
DOWNLOAD (top
of page) |
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If your connection drops during download, try again. Possibly at a different time. If you cannot download
at all, please e-mail your address and we will send you the CD ROM by mail (US and Canada only).
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| FEATURES
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| ISO
Organizer |
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The software is built around a special file
browser that displays files under configurable tabs. With ISO Organizer
you can:
- Organize and distribute your ISO 9001 documentation
- Organize and maintain records
The software is very simple and flexible.
You can learn how to use it in minutes (there are only nine menu
items), and you can use it to organize any system of documents (quality
system, environmental system, engineering project, etc.).
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| Document Formats
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The generic quality manual, operational procedures, and forms loaded
into the software are MS Word documents. However, the software can
handle any other type of documents, such as excel, power point,
drawing, acrobat (pdf), etc.
All generic documents are based on professional looking templates
including:
- Headers with company logo and document title boxes,
- Footers with signature boxes,
- Automatic page numbering, and
- Preset paragraph styles for headings, clauses and bullets.
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| Tutorial
(top of page) |
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The implementation tutorial consists of extensive tips,
notes and comments (in blue italic font) inserted directly
in the documents to which they pertain. The purpose of these comments
is to:
- Identify and explain the requirements which are being addressed
in the particular section of the manual or operational procedure,
- Alert you to sections and clauses 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 anticipating your questions and
helping you in real time as you work with a particular document.
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| LIST OF DOCUMENTS (top of page)
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| 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 |
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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 |
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| Quality System Forms
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| 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) |
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| Related Products: |
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| Organizer Screenshot: |

Click to enlarge |
| Brochures & Samples: |
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