ISO 13485 Training
ISO 13485 Certified Lead Implementer Training
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 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 identify the risks and opportunities associated with an organization effectively, according to the 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 devises Quality auditors who want to fully understand the implementation process of ISO 13485 standard
- Medical devises 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 an 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
Day 2: Plan the implementation of the Medical Devices Quality Management System
Day 3: Deploying the Medical Devices Quality Management System
Day 4: MDQMS measurement, continuous improvement and preparation for certification audit
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 an 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 an MDQMS based on ISO 13485
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can evaluate, monitor, and measure the performance of an 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 an 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 QMS 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 QMS 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 QMS related work experience | Medical Devices Quality Management System activities totaling 1000 hours | Signing the PECB code of ethics |
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