Standard requirements of EN ISO 13485

Objectives: Presentation of the requirements of the new ISO 13485: 2016 - changes and transition, standard used in the implementation, evaluation and certification of the quality management system in the medical industry. The course will provide the necessary elements to identify the requirements for the content and implementation of an appropriate quality management system.

Target audience: Addresses staff from different organizations participating in the implementation, maintenance and certification of a quality management system in the medical industry. Personnel from manufacturing or service companies involved in the development, control or management of processes - engineers in the quality department, process, production, department heads, etc.

Duration: 2 days

Agenda:

• Introduction (participant presentation, lecturer, Effective Flux)
• Introduction to quality management
• Management responsibility
• Resources management
• Planning
• Acquisitions
• Provision of services
• Measurement, analysis and improvement
• Comparison between different versions and correspondence with other standards
• Discussions. Examination. Close course

Trainer:
Trainer with over 15 years of experience in industry and consultancy with expertise in the use of course and training tools.

For more information, please contact us.