ISO 13485 - Foundation


Summary

This course enables participants to learn about the best practices for implementing and managing Medical Devices Quality Management System (MDQMS) as specified in ISO 13485:2016. The participant will learn the different components of a MDQMS such as quality manual, required procedures, records, measuring performance, management commitment, internal audit, management review and maintaining effectiveness.

 

Who should attend?

  • Members of a medical devices quality team
  • Professionals from the medical device industry wanting to gain a comprehensive knowledge of the main processes of a Quality
  • Management System (QMS) for Medical Devices
  • Staff involved in the implementation of ISO 13485 standard
  • Staff involved in operations related to a Quality Management System for Medical Devices
    Auditors

 

Learning Objectives

  • To understand the implementation of Medical Devices Quality Management System in accordance with ISO 13485
  • To understand the relationship between Medical Devices Quality Management System and compliance with customer and regulatory requirements
  • To know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Medical Devices Quality Management System.
  • To acquire the necessary knowledge to contribute in the implementation Medical Devices Quality Management System as specified in ISO 13485

 

Course Agenda

Day 1: Introduction to Medical Devices Quality Management System 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 13485:2016 and Certification Exam
Implementation phases of the ISO 13485 framework
Improvement of Quality
Conducting an ISO 13485 certification audit
Certification Exam

 

Prerequisites

None

 

Educational Approach

This training is based on both theory and practice:
Sessions of lectures illustrated with examples based on real cases
Review exercises to assist the exam preparation
Practice test similar to the certification exam
To benefit from the practical exercises, the number of training participants is limited
Examination and Certification
The “Certified ISO 13485 Foundation” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:
Domain 1: Fundamental principles and concepts of Quality Management and Medical Devices
Domain 2: Quality Management System for Medical Devices (MDQMS)

The “Certified ISO 13485 Foundation” exam is available in different languages (the complete list of languages can be found in the examination application form)
Duration: 1 hour
For more information about the exam, refer to PECB section on ISO 13485 Foundation Exam
A certificate of Certified ISO 13485 Foundation will be issued to participants who successfully pass the exam and comply with all the other requirements related to this credential
For more information about ISO 13485 certifications and PECB certification process, refer to PECB section on ISO 13485 Foundation Certification
General Information
Exam and certification fees are included in the training price
A student manual containing over 200 pages of information and practical examples will be distributed to participants
A participation certificate of 14 CPD (Continuing Professional Development) will be issued to participants
In case of failure of the exam, participants are allowed to retake the exam for free under certain certifications