ISO 13485 Lead Implementer (5 days)

Mastering the implementation and management of a Quality Management System (QMS) based on ISO 13485

This five-day intensive course enables participants to develop the necessary expertise to support an organization in implementing and managing a Quality Management System (QMS) based on ISO 13485:2003. Participants will also gain a thorough understanding of best practices used to implement quality processes based on requirements from ISO 13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems – Guidelines for Quality Management in Projects). This training is fully compatible with ISO 14969 guidance's (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485:2003).

Who should attend?

  • Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality Management System (QMS)
  • Quality executives
  • ISO 13485 auditors who wish to fully understand the Quality Management System implementation process
  • Persons responsible for the quality or conformity in an organization
  • Members of a quality team
  • Expert advisors in Quality Management Systems
  • Regulatory affairs managers
  • Technical experts wanting to prepare for a quality function or for a QMS project management function in the medical device industry

Learning objectives

  • To understand the implementation of a Quality Management System in accordance with ISO 13485
  • To gain a comprehensive understanding of the concepts, approaches, standards, methods and techniques required for the effective management of a Quality Management System
  • To understand the relationship between the components of a Quality Management System and the compliance with customer and regulatory requirements
  • To acquire necessary expertise to support an organization in implementing, managing and maintaining a QSM as specified in ISO 13485
  • To acquire necessary expertise to manage a team implementing ISO 13485
  • To develop knowledge and skills required to advise organization on best practices in the management of quality
  • To improve the capacity for analysis and decision making in the context of quality management
  • To prepare an organization for an ISO 13485 audit

Course Agenda

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

  • Introduction to management systems and the process approach
  • Normative frameworks and methodologies related to Quality and Medical Devices
  • Understanding the requirements of ISO 13485:2003
  • Quality Management System
  • Management responsibility
  • Resource management
  • Product realization
  • Measurements, analysis and improvement
  • Fundamental principles of Quality and Medical Devices
  • Initiating the QMS implementation

Day 2: Planning the implementation of a QMS based on ISO 13485

  • Writing a business case and a project plan for the implementation of a QMS
  • Definition of the scope of the QMS
  • Development of a QMS policy

Day 3: Implementing a QMS based on ISO 13485

  • Implementation of a document management framework
  • Design of controls and writing of procedures
  • Development of a training and awareness program and communicating about the quality
  • Product realization processes
  • Operations management of a QMS

Day 4: Controlling, monitoring and measuring a QMS and the certification audit of a QMS in accordance with ISO 13485

  • Controlling and monitoring a QMS
  • ISO 13485 Internal Audit
  • Management review of a QMS
  • Implementation of an improvement program
  • Preparing for an ISO 13485 certification audit

Day 5: Certification Exam

Prerequisites

ISO 13485 Foundation Certification or a basic knowledge of ISO 13485 is recommended

Educational approach

  • This training is based on both theory and practice:
  • Sessions of lectures illustrated with examples based on real cases
  • Practical exercises based on a full case study including role playing and oral presentations
  • Review exercises to assist the exam preparation
  • Practice test similar to the certification exam
  • Benefit from the practical exercises, the number of training participants is limited

Exam

  • The "Certified ISO 13485 Lead Implementer" 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 and medical devices
    • Domain 2: Quality Management System Best Practice based on ISO 13485
    • Domain 3: Planning a QMS based on ISO 13485
    • Domain 4: Implementing a QMS based on ISO 13485
    • Domain 5: Performance evaluation, monitoring and measurement of a QMS based on ISO 13485
    • Domain 6: Maintaining the effectiveness of a QMS based on ISO 13485
    • Domain 7: Preparing for a QMS certification audit
  • The "Certified ISO 13485 Lead Implementer" exam is available in different languages (the complete list of languages can be found in the examination application form)
  • Duration: 3 hours
  • For more information about the exam, refer to PECB section on ISO 13485 Lead Implementer Exam

Certification

  • 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 ISO 13485 certifications and PECB certification process, refer to PECB section on ISO 13485 Lead Implementer Certification

    General Information

    • Exam and certification fees are included in the training price
    • A student manual containing over 450 pages of information and practical examples will be distributed to participants
    • A participation certificate of 31 CPD (Continual Professional Development) credits will be issued to participants
    • In case of failure of the exam, participants are allowed to retake the exam for free under certain conditions

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