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