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