For a comprehensive Quality Management System for medical devices, the ISO 13485:2016 Auditor Course offers training and certification to help users become Certified ISO 13485 Internal Auditors. This ISO 13485 internal auditor training online course covers everything needed to understand the Quality Management System and fulfill requirements as an ISO 13485:2016 QMS auditor. It guides both management and employees of organizations involved in manufacturing, supply, or distribution of medical devices or components to become ‘Certified internal auditors’ for Quality Management System based on the ISO 13485:2016 standard. The online ISO 13485 auditor training imparts knowledge on how to conduct internal audits within such organizations. Successful completion of this ISO 13485 auditor training qualifies participants as certified internal auditors with an ISO 13485 Internal Auditor certificate.
TOPICS COVERED UNDER ONLINE ISO 13485:2016 AUDITOR COURSE
This ISO 13485 auditor training online course is divided into four sections:
- Lectures: The course consists of 8 lecture sessions, presented as slideshows with explanatory audio, covering topics such as Overview of ISO 13485:2016, ISO 13485 Principles, ISO 13485:2016 Requirements, Control of Documents and Records, ISO 13485:2016 Quality Management System Internal Audit, ISO 13485:2016 Internal Audit Records, Risk Management, and Steps for ISO 13485:2016 QMS Installation & Certification.
- Handouts: Handouts for all eight topics, totaling over 160 pages in PDF format, can be downloaded and saved for offline reading. They provide detailed knowledge of the covered topics.
- Exam: The course includes a total of 7 session exams and one final exam. Upon passing these exams, participants can download and print their ISO 13485:2016 Certified Internal Auditor training certificate.
- Audit Checklist: A complete set of more than 200 audit questions, categorized by ISO 13485:2016 clauses and departments, is provided as a tool for performing internal audits. This ISO 13485:2016 audit checklist helps participants prepare for the final audit and can be downloaded for future reference during the audit process.
COURSE OBJECTIVES
Upon completing the Online ISO 13485 auditor training course, participants will be able to:
- Familiarize themselves with ISO 13485:2016 quality management system requirements clauses and sub-clauses
- Gain an overview of ISO 13485:2016 quality management system (QMS) and its benefits
- Understand the high-level structure and framework of QMS
- Comprehend general and structural requirements of ISO 13485:2016 standard
- Know resource and process requirements for QMS
- Understand management system requirements
- Comprehend documentation and list of procedures and records to be maintained as an internal auditor
- Acquire knowledge of internal auditing and use of audit checklist
- Understand the processes involved in auditing
- Learn about types of auditing and questioning techniques
- Understand how to prepare and maintain internal audit records
- Access a ready-to-use internal audit checklist with clause-wise questions for effective audits
- Understand new concepts of risk management and evaluation techniques, and the process approach
- Form a team of internal auditors to establish a quick and effective system for ISO 13485:2016 accreditations
WHO SHOULD ATTEND ISO 13485 ONLINE AUDITOR TRAINING COURSE?
This course is developed by Finesse Consults Ltd, an ISO/IEC 17024 accredited training provider company, for working professionals, college students, and individuals seeking to enhance their careers. It is also suitable for graduates, undergraduates, management students, entrepreneurs, quality managers, technical managers, and more.
AUTHORS & INSTRUCTORS
For details about the authors, trainers, and instructors’ experience and background, please visit our trainers page. They possess extensive experience in the subject.
STUDY MATERIALS
This e-Learning course is provided with study materials that can be accessed after logging in or downloaded in PDF format. 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.
