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This book 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.
This book 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.
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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).
Inhaltsangabe
1: About this book 2: Introduction 3: What to know before getting started 4: Getting started 5: Writing the quality manual 6: Writing the Standard Operating Procedures 7: QMS documentation (SOP 1) 8: CAPA, monitoring & improvement (SOP 2) 9: Infrastructure (SOP 3) 10: Human resources (SOP 4) 11: Suppliers & distributors (SOP 5) 12: Auditing (SOP 6) 13: Communication, marketing & sales (SOP 7) 14: Risk management (SOP 8) 15: Clinical evidence (SOP 9) 16: Product realization (SOP 10) 17: Regulatory affairs (SOP 11) 18: Post market surveillance (SOP 12) 19: Finalizing all the SOPs 20: Writing templates, forms, records, and registries 21: Writing meeting agendas and minutes 22: QMS software validation 23: The launch 24: Training 25: Document review 26: Audits 27: Management review 28: Certification 29: Business as usual 30: What to know when you are up and running 31: Conclusion
1: About this book 2: Introduction 3: What to know before getting started 4: Getting started 5: Writing the quality manual 6: Writing the Standard Operating Procedures 7: QMS documentation (SOP-1) 8: CAPA, monitoring & improvement (SOP-2) 9: Infrastructure (SOP-3) 10: Human resources (SOP-4) 11: Suppliers & distributors (SOP-5) 12: Auditing (SOP-6) 13: Communication, marketing & sales (SOP-7) 14: Risk management (SOP-8) 15: Clinical evidence (SOP-9) 16: Product realization (SOP-10) 17: Regulatory affairs (SOP-11) 18: Post-market surveillance (SOP-12) 19: Finalizing all the SOPs 20: Writing templates, forms, records, and registries 21: Writing meeting agendas and minutes 22: QMS software validation 23: The launch 24: Training 25: Document review 26: Audits 27: Management review 28: Certification 29: Business as usual 30: What to know when you are up and running 31: Conclusion
1: About this book 2: Introduction 3: What to know before getting started 4: Getting started 5: Writing the quality manual 6: Writing the Standard Operating Procedures 7: QMS documentation (SOP 1) 8: CAPA, monitoring & improvement (SOP 2) 9: Infrastructure (SOP 3) 10: Human resources (SOP 4) 11: Suppliers & distributors (SOP 5) 12: Auditing (SOP 6) 13: Communication, marketing & sales (SOP 7) 14: Risk management (SOP 8) 15: Clinical evidence (SOP 9) 16: Product realization (SOP 10) 17: Regulatory affairs (SOP 11) 18: Post market surveillance (SOP 12) 19: Finalizing all the SOPs 20: Writing templates, forms, records, and registries 21: Writing meeting agendas and minutes 22: QMS software validation 23: The launch 24: Training 25: Document review 26: Audits 27: Management review 28: Certification 29: Business as usual 30: What to know when you are up and running 31: Conclusion
1: About this book 2: Introduction 3: What to know before getting started 4: Getting started 5: Writing the quality manual 6: Writing the Standard Operating Procedures 7: QMS documentation (SOP-1) 8: CAPA, monitoring & improvement (SOP-2) 9: Infrastructure (SOP-3) 10: Human resources (SOP-4) 11: Suppliers & distributors (SOP-5) 12: Auditing (SOP-6) 13: Communication, marketing & sales (SOP-7) 14: Risk management (SOP-8) 15: Clinical evidence (SOP-9) 16: Product realization (SOP-10) 17: Regulatory affairs (SOP-11) 18: Post-market surveillance (SOP-12) 19: Finalizing all the SOPs 20: Writing templates, forms, records, and registries 21: Writing meeting agendas and minutes 22: QMS software validation 23: The launch 24: Training 25: Document review 26: Audits 27: Management review 28: Certification 29: Business as usual 30: What to know when you are up and running 31: Conclusion
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