ISO 13485 QMS Lead Implementer (ISO13485-LI)

Master the implementation and management of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485

Course Description

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a"PECB Certified ISO 13485 Lead Implementer" credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Audience

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

Delivery and duration

  • Self-Training: Learn at your own speed, on your own schedule and on your favorite device. Click here for details

Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

General Information

  • Exam and certification fees are included in the training price
  • Participant manual contains over 450 pages of information and practical examples
  • A certificate of attendance will be issued to the participants
  • In case of failure of the exam, participants are allowed to retake it for free under certain conditions

Course Agenda

Day 1: Introduction to ISO 13485 and initiation of a MDQMS

  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation

Day 2: Plan the implementation of the MDQMS

  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Quality Policy
  • Definition of the organizational structure

Day 3: Implementation of a MDQMS

  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product realization
  • Operations Management

Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • Closing the training

Day 5: Certification Exam

  • Duration: 3 hours

Examination and Certification

The "Certified ISO 13485 Lead Implementer" exam fully meets the requirements of the Examination and Certification Program (ECP). The exam covers the following competence domains:

  • Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2: Medical Devices Quality Management System
  • Domain 3: Planning a MDQMS implementation based on ISO 13485
  • Domain 4: Implementing a MDQMS based on ISO 13485
  • Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
  • Domain 6: Continual improvement of a MDQMS based on ISO 13485
  • Domain 7: Preparing for a MDQMS certification audit

The "Certified ISO 13485 Lead Implementer" exam is available in different languages including English, French, Spanish and Portuguese.

For more information about the exam, refer to PECB Exam Preparation Guide

After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Implementer, Certified ISO 13485 Implementer or Certified ISO 13485 Lead Implementer, depending on their level of experience.

A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential.

For more information about the certification process, refer to PECB section on ISO 13485 Lead Implementer

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Caribbean Self-Training Caribbean Self-Training Caribbean English 2014-08-01 to 2019-12-31 N/A 897.00 USD add to cart
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Africa Self-Training Africa Self-Training Africa English 2018-08-20 to 2019-12-31 N/A 897.00 USD add to cart
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