ISO 13485:2016

OBJECTIVES:

  • Application of quality management principles in the medical device industry
  • Familiarizing students with the terminology used in quality management standards for medical devices
  • Understanding the additional requirements for a quality management system implemented in medical device manufacturing organizations
  • Understanding of risk management requirements
  • Acquiring skills in identifying and establishing processes and their indicators
  • Preparing the participants to update the QMS with the additional requirements in their own organizations

WHO SHOULD ATTEND

  • Top management
  • Quality managers
  • Managerilor de nivel operaţional
  • Anyone interested in knowing the standards related to the quality management system for medical devices

PREREQUISITE KNOWLEDGE

  • Knowledge of ISO 9001

COURSE AGENDA

  • Identification of customers and products/services provided by student organizations
  • Presentation of terms and definitions (ISO 13485)
  • Comparative presentation of requirements for SMC (ISO 9001 + ISO 13485)
  • Theoretical presentations are alternated with practical examples of how to fulfill the requirements
  • It is exemplified with ways of approaching risk management
  • Conclusions and feedback

Module 7. Support

Module 8. Operation

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Lectures: 144

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