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
Year of publication: |
2022
|
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Authors: | Juuso, Ilkka |
Publisher: |
New York : Routledge |
Subject: | Qualitätsmanagement | Quality management | Standardisierung | Standardization | Medizinprodukt | Medical device | Einführung | Implementation | Software |
Saved in:
Online Resource
Extent: | 1 online resource (352 pages) |
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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
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