Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry

The book "Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry" is a practical guide to building or improving an existing QMS. It takes a hands-on approach, teaching the top 25 lessons to know before starting the development process and walking you through writing the quality manual and standard operating procedures, training staff, organizing an internal audit, executing a management review, and passing external audits. It includes real-world experience and checklists to ensure key documents and processes are fit for use. The book is intended to serve both experts and novices audiences, providing special insight into the most crucial and effective aspects of QMS.

Format: Hardback
Length: 346 pages
Publication date: 21 March 2022
Publisher: Taylor & Francis Ltd

The book "Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry" provides valuable insights and practical guidance for organizations seeking to implement an ISO 13485:2016 Quality Management System (QMS) in the medical device industry. It offers a comprehensive approach to building a QMS from scratch and achieving certification.

The book begins by covering the top 25 lessons to know before embarking on the QMS development journey. It then guides readers step-by-step through the process, including writing the quality manual and standard operating procedures, training staff, conducting internal audits, executing management reviews, and passing external audits.

One of the key strengths of the book is its hands-on approach, which enables readers to apply the knowledge gained to their specific situations. It provides detailed explanations and examples to help readers understand the requirements of ISO 13485 and how to effectively implement them within their organizations.

The book also emphasizes the importance of a Lean QMS, which focuses on continuous improvement and waste reduction. It offers practical tips and techniques for optimizing processes and reducing non-value-added activities, ensuring that resources are used efficiently and effectively.

In addition to its practical guidance, the book includes a wealth of real-world experience from the author's personal dive into quality management and from the experiences of other companies in the field. It provides handy checklists for ensuring key documents and processes are fit for use, helping organizations to avoid common mistakes and ensure compliance with the standard.

The book is designed to be accessible to a wide range of readers, including quality professionals, engineers, and managers. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section and reorganize its contents into a practical workflow for developing, maintaining, and improving a QMS.

Overall, "Developing an ISO 13485-Certified Quality Management System" is a valuable resource for organizations in the medical device industry seeking to improve their quality management systems and achieve certification. Its practical approach, real-world examples, and emphasis on continuous improvement make it an essential guide for anyone involved in quality management.

Dimension: 254 x 178 (mm)
ISBN-13: 9781032065748