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

by Ilkka Juuso

Developing an ISO 13485-Certified Quality Management 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.

346 pages, Hardcover

Published April 5, 2022

Reviews

[Darshan Shetty · Rating 4 out of 5]

I could not even believe, there was an actual book on ISO 13485 QMS published post-2020. To my pleasant surprise, there was one, fresh of the printers from 2022. I did have to jump through some hoops to acquire this book, but finally, I was able to get it, surf through it, and decide that I wanted to read it fully and take extensive notes.

The book is basically Dr. Juuso, the author’s experience in building the ISO 13485 QMS system from scratch for his company and passing the Certification Audit. It walks you through the minimum amount of processes and procedures you would need to create an ISO 13485 QMS, for small to mid-size Medical Device companies.

Personally, I have spent 7 years in the medical device industry in and around QMS, so I would say I was quite aware of all the topics covered in this book but the best thing this book did for me, is give me a sort of an out of body experience and self-awareness about my job.

There are a lot of movie references in the book which I did not see coming, especially Christopher Nolan movies, which I can tell the author is a huge fan of.

The Author did mention that he had to stay as generic as possible in this book so that it is applicable across the board for all medical device companies. I have taken tons of notes from this book as it applied to me which does not make sense to discuss here in the review since it's very industry specific.

But, reading this book made me realize what I would be interested in reading next as a consumer and a medical device QMS professional if Dr. Juuso is looking for another book idea, lol.

- More Personal Anecdotes and Case Studies on ISO 13485:2016 QMS
- Some sort of high-level benchmarking of various medical devices QMS processes
- A Collection of Common Mistakes you could do while creating an ISO 13485 QMS System

I did reach out to Dr. Juuso on Linkedin to express my thanks for writing this book but I will repeat it again here, Thank you for writing this book. It's very hard to find a consolidated narrative on this topic. All you can find are fragments on random forums. So as a medical device professional, it's a great pleasure to read through a well-crafted 300 pages of writing on ISO 13485 QMS.

[Štěpán · Rating 5 out of 5]

I wish I had read this book sooner. It is an excellent overview of the standard ISO 13485, and the commentary helps in understanding and clarifying some processes which the standard simply says but does not explain further. I was thrown into the world of standardization without much training or help from a senior. I think that had I had this book, I would have been able to orient myself faster, understand processes better, and improve the quality of my work. People starting with the standard will benefit tremendously from this book and experienced quality managers can see maybe a different, more down-to-earth approach to their work and systems.

As I devoured the standard, I multiple times had a moment where I realized how stupid I was and that some things could have been tweaked and made better by just not rushing or slightly thinking out of the box. The standard is pretty heartless, but Juuso`s writing is not, making it an engaging read and quite a joy to return to this book every day.

The best way to explain how the book felt to me is that it feels like you are having a beer with a colleague and listening to their experiences and knowledge. You won`t get an exact step-by-step. But you will understand how the requirements are built and what is expected from you. Here and there, you will share a laugh, and most importantly you will know you are not alone in thinking about these issues.

PS. one thing bothered me very much, next time, please, Mr. Juuso, use a block alignment next time :D

[Harry Harman]

Dr. Ilkka Juuso, DSc, has a doctorate in technology from the University of Oulu, Finland

ISO 13485 is the standard for medical devices.

the international Medical Device Single Audit Program (MDSAP)

IEC 62304 for software development, IEC 62366 for usability, ISO 14155 for clinical research, and ISO 14971 for risk management.

All the standards are available to buy from the local standardization organizations and the International Standardization Organization (ISO) itself.

Share the Knowledge but Not the Pain

My secret objective in sharing knowledge has also been to make myself redundant.

But the trick in striving for redundancy is, of course, that you are not delegating your own work to others; you are just making sure the system would cope without you, should it need to.

Another key concept to be aware of is the plan-do-check-act (PDCA) model, which is often used to describe work according to the standard.