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ISO 13485 MD QMS Lead Implementer Self-Study Training Course (PECB)

16 hours Online English Identifier: 154508371
ISO 13485 MD QMS Lead Implementer Self-Study Training Course (PECB)

Course Overview

What you'll learn

Upon completion of this course, learners will be able to: 

  • 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

Course Agenda

  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
  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
  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
  4. MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
    • Monitoring, measurement, analysis and evaluation
    • Management review
    • Treatment of problems and non-conformities
    • Improvement
    • Preparing for the certification audit
    • Competence and evaluation of implementers
    • Closing the training

Who This Course Is For

This course is designed for:

  • 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

The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

  • Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2: Medical Devices Quality Management System (MDQMS)
  • 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

About this course

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.

Certification

After successfully passing the exam, you can apply for one of the following credentials shown. You will receive a certificate once you comply with all the requirements related to the selected credential. 

  • PECB Certified ISO 13485 Provisional Implementer
  • PECB Certified ISO 13485 Implementer
  • PECB Certified ISO 13485 Lead Implementer
  • PECB Certified ISO 13485 Senior Lead Implementer

Enrolment information

By enrolling on this course you agree to your personal information being passed to PECB.

Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.

If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.com

General information

  • PECB will provide over 500 pages of instructional materials containing explanations, guidance, and practical examples.  
  • Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.
  • In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

The fee for this course covers:

  • Course Materials (for lifetime, please note that updated course materials are not included) 
  • First Exam
  • One resit exam (if required)
  • PECB Certification Fee
  • First Year PECB Annual Maintenance Fee (AMF)

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