Developing an ISO 13485-Certified Quality Management System : An Implementation Guide for the Medical-Device Industry

Chapter 1: About this bookChapter 2: IntroductionChapter 3: What to know before getting startedChapter 4: Getting startedChapter 5: Writing the quality manualChapter 6: Writing the Standard Operating ProceduresChapter 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 SOPsChapter 20: Writing templates, forms, records, and registriesChapter 21: Writing meeting agendas and minutesChapter 22: QMS software validationChapter 23: The launchChapter 24: TrainingChapter 25: Document reviewChapter 26: AuditsChapter 27: Management reviewChapter 28: CertificationChapter 29: Business as usualChapter 30: What to know when you are up and runningChapter 31: Conclusion

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Year of publication:	2022
Authors:	Juuso, Ilkka
Publisher:	New York : Routledge
Subject:	Qualitätsmanagement \| Quality management \| Standardisierung \| Standardization \| Medizinprodukt \| Medical device \| Einführung \| Implementation \| Software

Extent:	1 online resource (352 pages)
Type of publication:	Book / Working Paper
Language:	English
ISBN:	978-1-003-20286-8 ; 1-003-20286-1 ; 978-1-000-55068-9 ; 1-000-55068-0 ; 978-1-000-55066-5 ; 1-000-55066-4 ; 978-1-032-06574-8 ; 978-1-032-06573-1
Other identifiers:	10.4324/9781003202868 [DOI]
Source:	ECONIS - Online Catalogue of the ZBW

Persistent link: https://www.econbiz.de/10013460580