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 ISO 13485 FDA QSR (21 CFR 820) Quality Manual Templates
By: Jack Kanholm
10 Digit ISBN
iso13485fda
13 Digit ISBN :
iso13485fda
Jack Kanholm's ISO 13485 template documents covers both ISO 13485:2003
and FDA QSR ( 21 CFR Part 820 ) requirements in one integrated quality
system, fully compliant with both international and US FDA regulations.ISO 13485 FDA QSR 21 CFR 820: Quality Manual, 34 Operational Procedures and 26 FormsThis documentation 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 ( list of documents). Several sample documents are included in the MS Word files above. To view more documents and to see how they are integrated into the ISOXpress software, download the free trial of the ISOXpress ISO 13485 System Software. - 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 one of the first template quality system documentations 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. FREE SAMPLE DOCUMENTSThis template documentation consists of an 8-section Quality Manual, 34 Operational Procedures, 18 electronic forms, and 8 manual forms (list of documents). Here are a few sample documents (in the ISOXpress software all documents are available in editable MS Word files): 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.
LIST OF DOCUMENTS
ISO 13485 & 21 CFR 820 TEMPLATE DOCUMENTATION List of Documents
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! Please Note: This product is only available as a download (MS Word File)
Download InstructionsShipping is free as this is a download. After we review your order, the download instructions are sent via email. The download instructions are normally sent within one hour after ordering during normal USA business hours M-F 8am ET to 6pm ET. To expedite, please call 1-800-648-9510 after completing order.
Download instructions will be sent via email.
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| 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$850.00 |
| Your Price: |
US$850.00 |
| You Save: |
US$0.00 |
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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
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