ISO 13485:2016

Released on by Itay Abuhav
preview-18

  • ISO 13485:2016 Book Detail

  • Author : Itay Abuhav
  • Release Date : 2018-05-11
  • Publisher : CRC Press
  • Genre : Medical
  • Pages : 735
  • ISBN 13 : 1351000772
  • File Size : 98,98 MB
DOWNLOAD BOOK

ISO 13485:2016 by Itay Abuhav PDF Summary

Book Description: Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.

Disclaimer: www.yourbookbest.com does not own ISO 13485:2016 books pdf, neither created or scanned. We just provide the link that is already available on the internet, public domain and in Google Drive. If any way it violates the law or has any issues, then kindly mail us via contact us page to request the removal of the link.

ISO 13485:2016

ISO 13485:2016

File Size : 99,99 MB
Total View : 1183 Views
DOWNLOAD

Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more

ISO 9001

ISO 9001

File Size : 13,13 MB
Total View : 1745 Views
DOWNLOAD

This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of in

ISO 13485

ISO 13485

File Size : 75,75 MB
Total View : 1109 Views
DOWNLOAD

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Gu

ISO 13485

ISO 13485

File Size : 52,52 MB
Total View : 7610 Views
DOWNLOAD

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Gu

ISO 9001

ISO 9001

File Size : 1,1 MB
Total View : 4653 Views
DOWNLOAD

What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects?