ISO 13485 PDF ePub eBook

Books Info:

ISO 13485 free pdf 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 Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and sub clause through quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records. The book is organized like the standard itself -- the table of contents is identical to the ISO 13485 Standard's table of contents -- making it user friendly, familiar, and unintimidating. You can use the book as a consulting session -- read it, explore it ,extract ideas -- and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.

About Itay Abuhav

Eng. Itay Abuhav, based in Switzerland, served for many years as a quality manager and consultant for international companies in various fields and industries among them the medical device industry. He has certified and provided consultation to a number of medical device factories in quality management for the ISO 13485 standard.

Details Book

Author : Itay Abuhav
Publisher : CRC Press Inc
Data Published : 18 October 2011
ISBN : 1439866112
EAN : 9781439866115
Format Book : PDF, Epub, DOCx, TXT
Number of Pages : 374 pages
Age + : 18 years
Language : English
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