ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel [Paperback]

Jack Kanholm (Author)

Book Description

Publication Date: July 1, 1998

This workbook contains a general orientation course on ISO 13485 (EN46000) quality systems. It is intended for training personnel in companies that either operate an ISO 13485 quality system or are implementing it and preparing for certification. The course explains what the standards are, how the quality systems works, and how everyone should prepare themselves and their work areas for the certification audit. The workbook is intended for distribution to all personnel for self–study or group training, and it includes a short multiple-choice test and a certificate of completion. This course satisfies ISO 13485 (EN 46000) requirements for training personnel in understanding and operating the quality management system. Table of contents is provided in the Book Information menu on the left side of this page.

Editorial Reviews

From the Publisher

This ISO 13485 (EN 46000) series is the latest addition to our publications on quality management standards. In 1992 we published Jack Kanholm's ISO 9000 series and in 1995 his QS-9000 series. Both established themselves as the reference of choice for understanding, interpreting and implementing these standards - selling over 90,000 copies. The ISO 13485 (EN 46000) series is very similar in its structure and approach. Based on the success of his previous books, we also published recently Jack Kanholm's ISO 14000 series on environmental management standards.

From the Author

Encouraged by the success of my ISO 9000 and QS-900 books, I decided to write a similar series for the EN 46000 and ISO 13485 standards. For this project I teamed with Lynette Howard, who brought to these books her insight and experience with the medical device industry and the regulatory issues. I wrote these books as much for myself and my colleagues, as for the quality managers that are on the receiving side of the audit. As a professional auditor I have to be perfectly clear and certain what the requirements of the standard are, and there is no better way to clear one's mind and consolidate the experience then writing a book. With my previous books I learned that people implementing quality management standards in their companies need authoritative and technical texts that will enable them to fully understand where the bottom line is for each and every requirement of the standard; and that they appreciate the directness, focus, clarity and simplicity of the writing. This is a proven, winning formula, and we certainly applied it again writing these ISO 13485 (EN 46000) books.

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Product Details

• Paperback: 32 pages
• Publisher: A Q a Co; 1st edition (July 1, 1998)
• Language: English
• ISBN-10: 1882711173
• ISBN-13: 978-1882711178
• Product Dimensions: 9.5 x 6.7 x 0.1 inches
• Shipping Weight: 2.4 ounces
• Average Customer Review: 5.0 out of 5 stars  See all reviews (2 customer reviews)
• Amazon Best Sellers Rank: #1,818,299 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

1 of 1 people found the following review helpful:

5.0 out of 5 stars ISO 13485 hand book, June 29, 2009

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Danna A. Mancini (Worcester, MA) - See all my reviews
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This review is from: ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (Paperback)

This is a very good product for training employees with respect to ISO 13485 registration, as well as the general ISO 9000 standard. The handbook comes with a mini exam also, making it a good document for training records.

1 of 1 people found the following review helpful:

5.0 out of 5 stars An easy, effective way to get basic training in, February 25, 2008

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E. de Feo - See all my reviews
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This review is from: ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (Paperback)

This training program is 100% worth it. It is a non-resource intensive way to get everyone trained on ISO basics - required for certification. Also, it introduced the language of ISO and the way that ISO thinks about process. We will continue to use this for all new hires and I would use it again for any new implementation.