ISO 13485:2016 : a complete guide to quality management in the medical device industry /

"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality managemen...

Description complète

Détails bibliographiques
Cote:Libro Electrónico
Auteur principal: Abuhav, Itay (Auteur)
Format: Électronique eBook
Langue:Inglés
Publié: Boca Raton : CRC Press, Taylor & Francis, [2018]
Édition:Second edition.
Sujets:
Medical instruments and apparatus industry > Standards.
Quality control.
Quality control > Handbooks, manuals, etc.
Quality Control
Qualité > Contrôle > Guides, manuels, etc.
Médecine > Appareils et instruments > Industrie > Normes.
Qualité > Contrôle.
quality control.
BUSINESS & ECONOMICS > Industries > General.
Handbooks and manuals.
Accès en ligne:Texto completo
Table des matières:
  • Scope
  • Normative references
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement.

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