|
|
|
|
|
 ISO 13485 FDA QSR (21 CFR 820) Quality Manual Templates
By: Jack Kanholm
10 Digit ISBN
iso13485fda
13 Digit ISBN :
iso13485fda
ISO 13485 FDA QSR 21 CFR 820: Quality Manual, 34 Operational Procedures and 25 Forms - 3rd Edition
Since 1996 thousands of companies have successfully achieved registration and compliance using Mr. Kanholm's ISO 13485 template documents. This edition covers both ISO 13485 2003 and FDA QSR ( 21 CFR Part 820 ) requirements, and thus fully complies with both the international and US FDA regulations. It defines a quality system that is simple, intuitive, and free from excessive paperwork, making it easy to operate and maintain.
- 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.
Originally published in 1996, this was the first template quality system documentation for the medical device industry. Now in its third edition, and with over 3,000 copies sold, it has helped thousands of companies to achieve ISO 13485 registration and/or FDA QSR compliance.
SOFTWARE FEATURES
ISO Manager
The software is built around a special file browser and server, the ISO Manager, for managing your ISO 9001 documents and records. With the ISO Manager you can:
- Develop, organize and distribute your ISO 9001 documentation,
- Create and maintain records, and
- Control all your documents.
You can use this software to create a network-based, paperless quality management system, or to manage the master files for your paper-based documentation.
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 manage any system of documents (quality system, environmental system, engineering project, etc.).
Document Formats
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.
Tutorial
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.
SAMPLES
DEMO DOWNLOAD
ISO 13485 Documentation ISO13485DocDemo.zip (5.3 MB) Please Note: This product is only available as a download (MS Word File)
Download InstructionsSelect DOWNLOAD for shipping option
when ordering this item as no shipping charges apply. Download
instructions are normally emailed to you within one to two hours, during normal
USA business days. To expedite, please call 1-800-648-9510 after
completing order.
Buy the Complete ISO 13485 System Package and Save!
The ISO 13485 FDA QSR (21 CFR 820) Quality Manual Templates is part of the Complete ISO 13485 System Package
which is bundled together to save you money over buying components
individually. Get all five ISO 13485 products bundled into a complete,
integrated system and save $427!
|
| Product Title: |
ISO 13485 FDA QSR (21 CFR 820) Quality Manual Templates |
| 10 Digit ISBN/Part Number: |
iso13485fda |
| 13 Digit ISBN: |
iso13485fda |
| Author: |
Jack Kanholm |
| Publisher: |
AQA Press, ISOXpress |
| Publication Date: |
2004 |
| Media: |
Software |
| Usually ships
within: |
1 |
| Retail Price: |
US$890.00 |
| Your Price: |
US$890.00 |
| You Save: |
US$0.00 |
|
|
Ask a question about this product
Add this product to your wish list
Keywords: iso 13485 fda qsr, 21 cfr 820, quality manual templates, us fda regulations, quality sytem management, qms, iso 13485 compliance, iso 13485 certification, fda qsr compliance, quality systems regulation, case fatality ratio, iso 13485 quality manual
|
|
Please review these other products:
|
Customers who bought this item also bought
|
5S Red Tags With Wire Ties Attached
The Red Tag system is a method used to identify items that are found in the work area, but their use and need are unknown. The tags come with 12" 26-gauge wire ties already attached. Sold in packages of 100. |
Our Price: US$15.99
click to see more
|
|
Breakthrough Kaizen Events DVD
Part of the Shingo Prize winning Manufacturing Insights Video Series, this program shows an actual kaizen event at the Lantech Corp. where a total of more than 100 improvements were completed. Length: 20 minutes. |
Our Price: US$108.00
click to see more
|
|
|
|
|
5860:iso 13485 fda qsr, 21 cfr 820, quality manual templates, us fda regulations, quality sytem management, qms, iso 13485 compliance, iso 13485 certification, fda qsr compliance, quality systems regulation, case fatality ratio, iso 13485 quality manual
|
| |
