ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry - Rilegato

Abuhav, Itay

9781439866115: ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry

Rilegato

ISBN 10: 1439866112 ISBN 13: 9781439866115

Casa editrice: CRC Press, 2011

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.

Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

L'autore:

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.

Contenuti:

Scope
General
Application

Normative References

Terms and Definitions Requirements

Quality Management System
General Requirements
Documentation Requirements

Management Responsibility
Management Commitment Requirements
Customer Focus
Quality Policy
Planning
Responsibility, Authority, and Communication
Management Review

Resource Management
Provision of Resources
Human Resource Requirements
Infrastructure Requirements
Work Environment Requirements

Product Realization
Planning of Product Realization
Customer-Related Processes
Design and Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring Device Requirements

Measurement, Analysis, and Improvement
Measurement, Analysis, and Improvement—General Requirements
Monitoring and Measurement
Control of Nonconforming Products
Analysis of Data
Improvement