Day 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485

Introduction to ISO 13485, other related standards and other framework related to Quality

Introduction to management systems and the process approach

Fundamental principles of Quality Management and Medical Devices

General requirements: presentation of the clauses 4 to 8 of ISO 13485

Day 2: Implementing requirements from ISO 13485:2003 and Certification Exam

Implementation phases of the ISO 13485 framework

Improvement of Quality

Conducting an ISO 13485 certification audit

Certification Exam

Taken from PECB <https://pecb.com

Members of a quality team

Professionals from the medical device industry wanting to gain a comprehensive knowledge of the main processes of a Quality Management System (QMS)

Staff involved in the implementation of ISO 13485 standard

Staff involved in operations related to a QMS

Auditors

To understand the implementation of a Quality Management System in accordance with ISO 13485

To understand the relationship between a Quality Management System and compliance with customer and regulatory requirements

To know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Quality Management System as specified in ISO 13485

To acquire the necessary knowledge to contribute in implementing a Quality Management System as specified in ISO 13485

شهادة معتمدة من البورد البريطاني للتقييم المهني ( PECB( Professional Evaluation And Certification Board والمعتمد من معهد المعايير الوطنية الامريكية ANSI

Certified ISO 13485 Foundation