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

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ISBN 9781439866115
Cat# K12946



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ISBN 9781439866122
Cat# KE13170



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  • Presents from-the-trenches advice from a quality manager to quality managers and other organizational parties
  • Clarifies and interprets the ISO 13485 Standard requirements in detail
  • Refers to the harmonization of regulatory requirements with the quality management system and the integration of risk management activities throughout the realization processes (with reference to the ISO 14791 standard)
  • Provides a large number of examples of how one can implement the requirements drawn from various sectors and industries
  • Puts words into actions, translating the requirements and objectives into feasible activities and tasks
  • Includes a full and comprehensive reference to the interrelations between the different clauses and sub clauses of the standard.
  • Compares the ISO 13485 requirements alongside the ISO 9001 requirements using tables presenting both of the standards requirements providing a sound understanding of these new procedures



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.

Table of Contents


Normative References

Terms and Definitions Requirements 

Quality Management System
General Requirements
Documentation Requirements

Management Responsibility
Management Commitment Requirements
Customer Focus
Quality Policy
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
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

Author Bio(s)

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.