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Since 1996 thousands of companies have successfully
achieved registration and compliance using Mr. Kanholm’s ISO
13485 template documents. This new edition combines ISO 13485:2003
and FDA QSR (21 CFR Part 820) inot one integrated quality system.
- Fully developed generic documentation with
everything you need for ISO 13485 certification, including quality
manual, procedures and forms. (list of documents)
- While organized into an ISO
13485:2003 system, the documentation also specifically covers
FDA QSR (21 CFR Part 820) requirements, and thus complies
with both the international and US FDA regulations. Also
instructions how to take out the QSR-related sections if
you only need to comply with ISO 13485.
- 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 and MS Excel formatted
documents, forms and templates. (You can choose MS Word or MS Excel forms.)
- 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 third edition, and with 3,000
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 13485 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
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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 - QUALITY POLICY |
| 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 |
pRroduction Control |
| 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 |
Device Master Record |
| QOP-42-03 |
Control of Records |
| QOP-54-01 |
Quality Objectives |
| QOP-56-01 |
Management Review |
| QOP-62-01 |
Competence, Awareness and Training |
| QOP-63-01 |
Equipment Maintenance |
| QOP-64-01 |
Production and Work Environment |
| QOP-71-01 |
Production Planning and Risk Management |
| QOP-72-01 |
Order Processing for Catalog Products |
| QOP-72-02 |
Order Processing for Custom Products |
| QOP-73-01 |
Design Control |
| QOP-73-02 |
Control of Design and Process Changes |
| QOP-74-01 |
Supplier Evaluation and Monitoring |
| QOP-74-02 |
Purchasing |
| QOP-74-03 |
Verification of Purchased Product |
| QOP-75-01 |
Production Work Order and History Record |
| QOP-75-02 |
Cleanliness and Contamination of Product |
| QOP-75-03 |
Validation of Processes and Software |
| QOP-75-04 |
Installation and Servicing |
| QOP-75-05 |
Product Identification and Traceability |
| QOP-75-06 |
Storage, Labeling and Packaging |
| QOP-75-07 |
Storage and Distribution |
| QOP-76-01 |
Measuring and Monitoring Equipment |
| QOP-82-01 |
Feedback and Customer Satisfaction |
| QOP-82-02 |
Internal Quality Audits |
| QOP-82-03 |
In-process Inspections |
| QOP-82-04 |
Final Acceptance Inspection |
| QOP-83-01 |
Control of Nonconforming Product |
| QOP-84-01 |
Analysis of Data |
| QOP-85-01 |
Continual Improvement |
| QOP-85-02 |
Device Recall and Advisory Notices |
| QOP-85-03 |
Customer Complaints |
| QOP-85-04 |
Corrective and Preventive Action |
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| Quality
System Forms |
| QF-42-01-1 |
Document Control Master List |
| QF-42-02-1 |
Device Master Record Index |
| QF-54-01-1 |
Quality Objectives Record |
| QF-73-01-1 |
Design Project Plan and Schedule |
| QF-73-02-1 |
Engineering Change Request (ECR) |
| QF-75-01-1 |
Production Work Order |
| QF-75-04-1 |
Service Report |
| QF-82-02-1 |
Internal Audit Plan |
| QF-82-02-2 |
Audit Nonconformity Report |
| QF-83-01-1 |
Product Nonconformity Report (PNR) |
| QF-85-04-1 |
Corrective Action Request (CAR) |
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| Related Products: |
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| Organizer Screenshot: |
Click to enlarge |
| Samples: |
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