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: Paperback / softback
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" delves into the lessons learned from a real-world project focused on building an ISO 13485:2016 Quality Management System (QMS) from scratch and subsequently obtaining official certification. It serves as a practical guide for individuals seeking to establish or enhance their existing QMS through proven solutions.

The book adopts a hands-on approach, beginning with an introduction to the top 25 lessons essential for understanding the development process. It then guides readers step-by-step through the creation of the quality manual and standard operating procedures, staff training, internal audit organization, management review execution, and the successful completion of external audits to achieve certification.

By providing a clear roadmap for progress, the book assists readers in efficiently transitioning from one task to the next, offering comprehensive guidance and essential information to accomplish each task swiftly and effectively. It does not aim to replicate the standard but rather delves deep into its core, reorganizing its contents into a practical workflow for developing, maintaining, and improving a Lean QMS.

The book incorporates a wealth of real-world experience from the author's personal journey in quality management, as well as insights from other companies in the field. It includes handy checklists to ensure key documents and processes are fit for use, with a strong emphasis on considering all relevant aspects. Furthermore, the book is designed to address common misunderstandings regarding QMS, offering valuable insights into its principles and requirements.

Rather than serving as a mere review of the standard with lengthy commentary, the book aims to provide a clear and concise understanding of ISO 13485:2016. It offers practical guidance and actionable tips to help organizations implement and maintain a robust QMS, ensuring the safety and effectiveness of medical devices and contributing to overall quality assurance in the medical-device industry.

Weight: 680g
Dimension: 254 x 178 (mm)
ISBN-13: 9781032065731