ISO 13485 Introduction Course ([Duration] Day)

Introduction to the implementation of Medical Devices Quality Management System based on ISO 13485

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Summary

This one-day training enables the participants to be familiar with the basic concepts of the implementation and management of Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. The participant will learn the different components of MDQMS, including the MDQMS manual, required procedures, measuring performance, management’s commitment, internal audit, management review and maintaining effectiveness.

Who should attend?

  • Professionals from the medical device industry wanting to gain a comprehensive knowledge of the main processes of Medical Devices Quality Management System (MDQMS)
  • Staff involved in the implementation of the ISO 13485 standard
  • Expert advisors in Quality Management for the medical device industry
  • Managers responsible for implementing MDQMS
  • Auditors

Learning objectives

  • To understand the fundamentals of Quality Management and Medical Devices
  • To know the interrelationships between ISO 13485 and other related standards
  • To know the key components of Medical Devices Quality Management System (MDQMS) in accordance with ISO 13485
  • To introduce the concepts, approaches, standards, methods and techniques allowing to effectively manage MDQMS
  • To understand the relationship between Medical Devices Quality Management System and compliance with customer and regulatory requirements
  • To understand the stages of the ISO 13485 certification process

Course Agenda

  • Introduction to ISO 13485, related standards and framework related to Quality
  • Introduction to management systems and the process approach
  • General requirements: presentation of the clauses 4 to 8 of ISO 13485
  • Implementation phases of the ISO 13485 framework
  • Improvement of Quality
  • Conducting an ISO 13485 certification audit

Prerequisites

None

Examination and Certification

None

General Information

  • A student manual containing over 100 pages of information and practical examples will be distributed to participants
  • Participation certificate of 7 CPD (Continuing Professional Development) will be issued to participants
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