ISO 13485 Lead Implementer Course

This five-day intensive course enables participants to develop the necessary expertise to support an organization in implementing and managing Medical Devices Quality Management System (MDQMS) based on ISO 13485:2016. 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).

Who should attend?

• Project managers or consultants wanting to prepare and support an organization in the implementation of Medical Devices Quality Management System (MDQMS)
• Quality executives
• ISO 13485 auditors
• Persons responsible for the quality or conformity in an organization
• Members of a quality team
• Expert advisors in Quality Management Systems
• Technical experts in QMS project management function in the medical devices industry

Learning objectives

• To understand the implementation of Medical Devices 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 Medical Devices 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 MDQMS 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 Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 and initiation of MDQMS
• Introduction to management systems and the process approach
• Normative frameworks and methodologies related to Quality and Medical Devices
• Understanding the requirements of ISO 13485:2016
• Fundamental principles of Quality and Medical Devices
• Initiating the MDQMS implementation

Day 2:

• Planning the implementation of MDQMS based on ISO 13485
• Writing a business case and a project plan for the implementation of MDQMS
• Definition of the scope of the MDQMS
• Development of MDQMS policy

Day 3:

• Implementing MDQMS 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 MDQMS

Day 4:

• Controlling, monitoring and measuring MDQMS and the certification audit of MDQMS in accordance with ISO 13485
• Controlling and monitoring MDQMS
• ISO 13485 Internal Audit
• Management review of MDQMS
• 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

Examination and Certification

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: Medical Devices Quality Management System Best Practice based on ISO 13485
• Domain 3: Planning MDQMS based on ISO 13485
• Domain 4: Implementing MDQMS based on ISO 13485
• Domain 5: Performance evaluation, monitoring and measurement of MDQMS based on ISO 13485
• Domain 6: Maintaining the effectiveness of MDQMS based on ISO 13485
• Domain 7: Preparing for MDQMS certification audit

Career Path

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