To fulfill all the requirements of a Quality Management System for medical devices, Finesse Consults Ltd offers an Online ISO 13485 Lead Auditor Training Course that provides training and certification. This course is particularly useful for users aiming to become a ‘Certified ISO 13485 Lead Auditor’. The ISO 13485 lead auditor training online equips participants with a comprehensive understanding of QMS and ISO 13485:2016 requirements, preparing them to function as ISO 13485 lead auditors. This online ISO 13485 lead auditor training course is designed to guide employees of any organization while enhancing their understanding of various activities related to Audit Techniques, Audit Processes, and Requirements. Upon successful completion of this online lead auditor training course, participants will be awarded an ISO 13485 Lead Auditor certificate.
TOPICS COVERED UNDER ISO 13485 LEAD AUDITOR TRAINING COURSE
This ISO 13485 lead auditor training online course is divided into 9 interactive online sessions. It incorporates lectures with audio-visual presentations, hand-outs, videos, and online exams to ensure a thorough understanding of the subject matter:
- Session 1: Overview of Course and Standard
- Session 2: ISO 13485 Principles
- Session 3: ISO 13485:2016 Requirements
- Session 4: Control of Documents and Records
- Session 5: Risk Management
- Session 6: ISO 13485:2016 Internal Audit Process
- Session 7: Audit Terms and Definitions and Roles and Responsibilities
- Session 8: Performing an Audit
- Session 9: Nonconformity and Corrective Action
Lectures:
The course consists of a total of 9 lecture sessions, each presented as a slideshow with explanatory audio and visuals to enhance understanding.
Hand-outs:
For all 9 sessions, hand-outs totaling 200 pages in PDF format are provided. Participants can download, save, print, or read these hand-outs offline to gain comprehensive knowledge of the 9 topics.
Manual:
Session 8 includes a practical example of a real-life quality management system manual for medical devices. This example aids participants in performing document reviews and understanding adequacy audit findings, contributing to better auditing skills.
Audit Checklist:
The ISO 13485 Audit checklist comprises over 400 audit questions organized according to ISO 13485:2016 standard requirements and departments. These checklists assist participants in preparing for the final audit.
Videos:
Actual videos demonstrating an audit with real-life audit questions and answers are included. These videos illustrate how to conduct an audit in an organization, including managing opening and closing meetings with management employees.
Exams:
The ISO 13485 lead auditor training course includes session exams and a final exam. Participants must pass all exams to receive an auto-generated ISO 13485:2016 Lead Auditor Training Certificate, which can be downloaded and printed.
COURSE OBJECTIVES
Upon completing the ISO 13485 lead auditor training course, participants will be able to:
- Familiarize themselves with ISO 13485:2016 requirements in detail
- Understand resource and process requirements
- Comprehend documentation required by ISO 13485:2016
- Understand documentation and list of procedures to be maintained and checked as a lead auditor
- Acquire knowledge of internal auditing and use of audit checklists
- Learn about types of auditing and questioning techniques
- Familiarize themselves with principles and implementation of ISO 13485:2016 lead audit programs
- Access a ready-to-use audit checklist with clause-wise questions for effective audits
WHO SHOULD ATTEND THIS COURSE?
This ISO 13485 Lead Auditor Training course is designed for working professionals, management students, and individuals looking to enhance their careers. It is also beneficial for graduates, undergraduates, management students, entrepreneurs, quality managers, technical managers, and others.
PREREQUISITES
Participants should have knowledge of Quality Management Systems and understand the Plan-Do-Check-Act (PDCA) cycle. Familiarity with quality management system principles and concepts such as assigning responsibility for quality, incorporating management commitment and stakeholder interests, enhancing societal values, and using risk assessments for controls is essential.
AUTHORS & INSTRUCTORS
For details about the authors, trainers, and instructors, including their experience and background, please visit our trainers page. They possess extensive experience in the subject.
STUDY MATERIALS
This e-Learning course provides study materials that can be accessed after logging in or downloaded in PDF format. These study materials reinforce key points and serve as reminders of learned concepts. Access to study materials is revoked after successfully clearing the exam and preparing the online certificate for the student.
EXAMINATION AND COURSE CERTIFICATE
All paid E-learning courses include a Course Certificate issued upon course completion and passing the session exams and final exam with a minimum score of 60%. Students who do not pass an exam have the option to retake it.
END OF COURSE INSTRUCTION
After completing the sessions and passing each session’s examination, students can proceed to the final exam. Successful completion of the final exam marks the end of the course. The training certificate is available on our LMS for printing or saving, and it can be verified using the name and certificate number.
