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.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
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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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