IMDM 01

Background

ISO 13485 defines the requirements when an organization needs to demonstrate its ability to consistently provide medical devices and associated services in accordance with customer requirements and applicable regulatory requirements. The ISO 13485 training - Mastering the requirements of the standard provides the necessary skills to understand the issues of ISO 13485, master all the requirements and know how to implement them effectively.

Educational objective

• Understand and identify the requirements of the NM ISO 13485 standard.
• Identify the provisions to implement to implement the quality approach according to the NM ISO 13485 standard

Who is concerned

Anyone wishing to understand and know how to implement ISO 13485. Management, quality manager, quality auditor, process drivers.

Content

   1. Reminder of the fundamentals      2- Analysis of the requirements of the NM ISO 13485 standard  - Quality management system • Management responsibility: commitment, responsiveness, policy and objectives; • Responsibilities and authorities; • Internal communication ; • Management review.

• Resource Management: • Human ressources • Infrastructures; • Work environment and control of contamination.

• Product realization: • Customer process • Development and design process • Purchasing • Production and service preparation:   - Mastery of the process;   - Facilities activities;    - Validation of the sterilization process: special requirements. • Measurement, analysis and improvement

3 -Study case