The QMS Book
Welcome to the source for quality management in medical devices
Welcome
ISO 13485 Quality Management, explained humanely
ISO 13485 is the standard when it comes to quality management in the context of medical devices. It is the present day in Europe and Canada, the next state-of-the-art in the United States, and the tomorrow in the rest of the global market. Through the Medical Device Single Audit Program (MDSAP), too, it applies from Brazil to Australia and Japan to the US. Knowing about the standard is required. Learning how to turn it into a business advantage is a must.
Getting to grips with the standard may seem daunting, we know. Don't worry. The standard makes a lot of sense if you learn it right. The book "Developing an ISO 13485-Certified Quality Management System - An Implementation Guide for the Medical-Device Industry" (Routledge 2022) by Dr. Ilkka Juuso is written to ease you into using the standard, and help you make the most of it.
The 350-page book is broken down into lessons you should know when diving into quality management, and the essentials of what goes into the Quality Manual and the Standard Operating Procedures you'll need to obtain compliance with the standard. The book is based on real-world examples and experience you can benefit from, right from the start or when you keep improving your QMS.
Over time we hope to build on this site so that you can read more about the book, access additional materials, reach out to us, and a lot more here. The book itself is widely available as E-BOOK, a PAPERBACK, and a HARDBACK version, from all major booksellers around the world, and on this site we provide a few of those links.
Other books
ISO 13485 is perhaps the biggest and brightest medical-device standard out there, but it is not the only one you should care about. Check out the following related books also.
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Medical-grade software
The sequel to the QMS book looks at software development for medical devices. This is the first book of its kind to negotiate together requirements from IEC 62304 and ISO 13485 which both place requirements on how software development takes place in the context of medical devices, whether that is software as a medical device or software in a medical device.
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Medical-device usability
The third book in the trilogy takes a practical walkthrough usability engineering. Here we approach usability engineering from the viewpoint of safety but also bring in lessons from the field of general usability engineering as is useful to a discussion of medical devices. We show how usability connects to the overall quality management and risk management activities of the organization, and how usability can actually inform the whole path from an initial product concept to a finished device and beyond. Our message is that usability engineering is not just something you have to do, it’s something you should want to do because of how it can add to your knowledge of your user, use environment, and the use of your device – and bring benefits to all of these.