Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions.

The book takes a hands-on approach–first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. It helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. It does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS.

The book includes a wealth of real-world experience both from the author's personal dive into quality management, and from the experiences of other companies in the field and provides handy checklists for ensuring key documents and processes are fit for use–the emphasis here is to help ensure you have considered all relevant aspects.

In addition, the book is not intended as a “cheat sheet” for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences–it provides special insight on the most crucial and effective aspects of QMS.

chapter Chapter 1|5 pages

About This Book

chapter Chapter 2|4 pages


chapter Chapter 3|49 pages

What to Know Before Getting Started

chapter Chapter 4|38 pages

Getting Started

chapter Chapter 5|29 pages

Writing the Quality Manual

chapter Chapter 6|9 pages

Writing the Standard Operating Procedures

chapter Chapter 7|11 pages

QMS Documentation (SOP-1)

chapter Chapter 8|9 pages

CAPA, Monitoring, and Improvement (SOP-2)

chapter Chapter 9|6 pages

Infrastructure (SOP-3)

chapter Chapter 10|6 pages

Human Resources (SOP-4)

chapter Chapter 11|7 pages

Suppliers and Distributors (SOP-5)

chapter Chapter 12|6 pages

Auditing (SOP-6)

chapter Chapter 13|10 pages

Communication, Marketing, and Sales (SOP-7)

chapter Chapter 14|7 pages

Risk Management (SOP-8)

chapter Chapter 15|3 pages

Clinical Evidence (SOP-9)

chapter Chapter 16|17 pages

Product Realization (SOP-10)

chapter Chapter 17|10 pages

Regulatory Affairs (SOP-11)

chapter Chapter 18|4 pages

Post-Market Surveillance (SOP-12)

chapter Chapter 19|4 pages

Finalizing All the SOPs

chapter Chapter 20|11 pages

Writing Templates, Forms, Records, and Registries

chapter Chapter 21|4 pages

Writing Meeting Agendas and Minutes

chapter Chapter 22|4 pages

QMS Software Validation

chapter Chapter 23|6 pages

The Launch

chapter Chapter 24|4 pages


chapter Chapter 25|4 pages

Document Review

chapter Chapter 26|21 pages


chapter Chapter 27|4 pages

Management Review

chapter Chapter 28|6 pages


chapter Chapter 29|5 pages

Business as Usual

chapter Chapter 30|8 pages

What to Know When You Are Up and Running

chapter Chapter 31|2 pages