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.
Table of Contents
Chapter 1: About this book
Chapter 2: Introduction
Chapter 3: What to know before getting started
Chapter 4: Getting started
Chapter 5: Writing the quality manual
Chapter 6: Writing the Standard Operating Procedures
Chapter 7: QMS documentation (SOP-1)
Chapter 8: CAPA, monitoring & improvement (SOP-2)
Chapter 9: Infrastructure (SOP-3)
Chapter 10: Human resources (SOP-4)
Chapter 11: Suppliers & distributors (SOP-5)
Chapter 12: Auditing (SOP-6)
Chapter 13: Communication, marketing & sales (SOP-7)
Chapter 14: Risk management (SOP-8)
Chapter 15: Clinical evidence (SOP-9)
Chapter 16: Product realization (SOP-10)
Chapter 17: Regulatory affairs (SOP-11)
Chapter 18: Post-market surveillance (SOP-12)
Chapter 19: Finalizing all the SOPs
Chapter 20: Writing templates, forms, records, and registries
Chapter 21: Writing meeting agendas and minutes
Chapter 22: QMS software validation
Chapter 23: The launch
Chapter 24: Training
Chapter 25: Document review
Chapter 26: Audits
Chapter 27: Management review
Chapter 28: Certification
Chapter 29: Business as usual
Chapter 30: What to know when you are up and running
Chapter 31: Conclusion
Dr. Ilkka Juuso, DSc, has a doctorate in technology from the University of Oulu, Finland, and 20+ years of experience working on multidisciplinary R&D projects in both industry and academia. He is one of the founders of the medical device startup Cerenion Ltd., and its Chief Operations Officer, Quality Manager and long-time board member. He is also a Senior Advisor with the medical device quality consultancy Kasve Oy, a post-doctoral researcher with the University of Oulu, and one of the founders of MetaVisual Ltd. specializing in online publishing using its own versatile content management platform.
Ilkka’s main interests are international regulatory affairs (incl. EU MDD/MDR and US FDA), ISO 13485 quality management and medical-grade software development. Marketing and business strategy are also always close to his heart. At Cerenion, Ilkka has led the development of an ISO 13485, ISO 14971, and IEC 62304 compliant Quality Management System (QMS) from the ground up, its subsequent day-to-day operation, and certification by a notified body. He has also had a key role in the development and launch of a CE-marked Class IIb medical device under the Medical Device Directive (93/42/EEC) of the European Union using that QMS.
Ilkka has a deep involvement in quality and regulatory affairs, including participation in international standardization activities concerning, for example, quality management, healthcare software, and both lifecycle and agile methods in software development. He is a member of several standardization groups under the national organizations for the International Organization for Standardization (ISO).