ISO 13485 Lead Implementer Training

ISO 13485 lead implementer training from Sync Resource will enable you to develop all the expertise to create, implement, maintain and manage a medical devices quality management system (MDQMS) based on ISO 13485 standard.

This training will also help you gain an in-depth understanding of the best practices of medical devices quality management systems, which will allow you to improve the overall performance, customer satisfaction and effectiveness of a medical devices quality management system, for any organization.

Learning Objectives

  • To understand the implementation of ISO 13485 for medical devices quality management
  • To support and prepare an organization for an ISO 13485 certification audit
  • To gain an in-depth understanding of the tools and techniques required for the effective medical devices quality management in accordance with ISO 13485 standard
  • To understand the relationship of ISO 13485 based medical devices quality management system with other ISO standards
  • To understand how ISO 13485:2015 works hand in hand with other ISO standards, to develop an integrated management system
  • To develop skills and gain the knowledge to help you identifying the risks and opportunities associated with an organization effectively, according to ISO 13485 standard
  • To understand the correlation between the components of ISO 13485 based medical devices quality management system and the compliance with the requirements of stakeholders of an organization
  • To acquire the necessary expertise to support an organization in creating, implementing, managing and maintaining a medical devices quality management system as specified in ISO 13485
  • To acquire the necessary expertise to lead a team of ISO 13485 implementers
  • To gain the knowledge and develop the skills required to advise an organization on best practices for the management of quality
  • To improve the capacity for analysis and decision making in the context of medical devices quality management

Who Should Attend?

  • Project managers, or consultants responsible for the implementation and maintenance of a medical devices quality management system, based on ISO 13485 standard principles, for an organization.
  • Medical Devices Quality auditors who want to fully understand the implementation process of ISO 13485 standard
  • Medical Devices Quality managers or team members responsible for the quality or conformity in an organization
  • Technical experts who want to prepare for a quality function or for a MDQMS project management function

ISO 13485 Lead Implementer Training

Course Agenda

Duration: 5 Days

Day 1: Introduction to ISO 13485 and initiation of a Medical Devices Quality Management System

  • Course objective and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Initiating the MDQMS implementation
  • Understanding the organization and clarifying the medical devices quality objectives

Day 2: Plan the implementation of the Medical Devices Quality Management System

  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Policies for quality management
  • Risk assessment
  • Planning of product and service provision
  • Definition of organizational structure of the MDQMS
  • Definition of the document management process

Day 3: Deploying the Medical Devices Quality Management System

  • Operations Management
  • Training and awareness plan
  • Communication plan
  • Product and service requirements, design, and purchasing process
  • Product and service realization and control

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

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

Day 5: Certification Exam

ISO 13485 Lead Implementer Training

Examination

The Sync Resource ISO 13485 lead implementer training fully meets the requirements of the PECB Examination and Certification Programme (ECP).

The “PECB 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

The exam covers the following competency domains:

Domain 1: Fundamental Principles and Concepts in Quality Management

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and illustrate the main Quality Management concepts related to a Medical Devices Quality Management System (MDQMS)

Domain 2: Quality Management best Practice based on ISO 13485

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and provide guidance on how to implement and manage the Quality Management requirements based on best practices of ISO 13485

Domain 3: Planning a MDQMS based on ISO 13485

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can plan the implementation of a MDQMS in preparation for an ISO 13485 certification

Domain 4: Implementing a MDQMS based on ISO 13485

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can implement the processes of a MDQMS required for an ISO 13485 certification

Domain 5: Performance Evaluation, Monitoring and Measurement of a MDQMS based on ISO 13485

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can evaluate, monitor and measure the performance of a MDQMS in the context of an ISO 13485 certification

Domain 6: Continual Improvement of a MDQMS based on ISO 13485

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can provide guidance on the continual improvement of a MDQMS in the context of ISO 13485

Domain 7: Preparing for a MDQMS Certification Audit

Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can prepare and assist an organization for the certification of a MDQMS against the ISO 13485 standard

ISO 13485 Lead Implementer Training

Certification

After successfully passing the exam, you can apply for the credentials shown on the table below. Certification will be provided once you comply with all the requirements related to the selected credential.

The requirements for PECB Implementer Certifications are: 

Credential Exam Professional Experience MDQMS Implementation Experience Other Requirements
PECB Certified ISO 13485 Provisional Implementer PECB Certified ISO 13485 Lead Implementer Exam None None Signing the PECB
code of ethics
PECB Certified ISO 13485 Implementer PECB Certified ISO 13485 Lead Implementer Exam Two years; One year of MDQMS related work experience Medical Devices Quality Management System activities totaling 200 hours Signing the PECB code of ethics
PECB Certified ISO 13485 Lead Implementer PECB Certified ISO 13485 Lead Implementer Exam Five years; Two years of MDQMS related work experience Medical Devices Quality Management System activities totaling 300 hours Signing the PECB code of ethics
PECB Certified ISO 13485 Senior Lead Implementer PECB Certified ISO 13485 Lead Implementer Exam Ten years; Seven years of MDQMS related work experience Medical Devices Quality Management System activities totaling 1000 hours Signing the PECB code of ethics

ISO 9001 Lead Implementer Training

General Information

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued
  • In case of exam failure, you can retake the exam within 12 months for free