ISO 13485 Certified Auditor Training

The ISO 13485:2016 Certified Internal Auditor Online Training Course is launched for fulfilling the needs of people who want to audit the Quality management system for medical devices. Anyone who wants to gain knowledge about ISO 13485 audit and get ISO 13485:2016 Auditor Certificate and become a certified ISO 13485:2016 Auditor can enroll in this course.

DESCRIPTION

For Quality management system of medical devices, the ISO 13485:2016 Auditor course provides training and certification that helps users to become Certified ISO 13485 Internal Auditor. In this ISO 13485 internal auditor training online course, you will learn everything you need to know about the Quality management system and fulfill all the requirements as an ISO 13485:2016 QMS auditor. This course will guide Management as well as employees of any organization in the field of manufacturing, supply or distribution of a medical device or its components, to qualify as ‘Certified internal auditor’ for Quality management system based on ISO 13485:2016 standard. The online ISO 13485 auditor training will acknowledge the participants about how to perform an internal audit in such organizations. Once this ISO 13485 auditor training is successfully completed online, participant will be qualified as a certified internal auditor with an ISO 13485 internal auditor certificate.

TOPICS COVERED UNDER ONLINE ISO 13485:2016 AUDITOR COURSE

 This ISO 13485 auditor training online course comprises four sections, as given below:

1. Lectures
   There is a total of 8 lecture sessions, which are given to the course participants as a presentation with explanatory audio to understand the subject. The topics discussed in the lecture sessions are listed below:
   • Session 1: Overview of ISO 13485:2016.
   • Session 2: ISO 13485:2016 Principles.
   • Session 3: ISO 13485:2016 Requirements.
   • Session 4: Control of Documents and Records.
   • Session 5: ISO 13485:2016 Quality Management System Internal Audit.
   • Session 6: ISO 13485:2016 Internal Audit Records.
   • Session 7: Risk Management.
   • Session 8: Steps for ISO 13485:2016 QMS Installation & Certification.
2. Handouts
   For all the above eight topics, the handouts are given in more than a total 160 pages in pdf format. The participant of this online ISO 13485 training can download and save the handouts in their computer and print them or read them offline to get detailed knowledge of all the eight topics mentioned above.
3. Exam
   In this online ISO 13485 auditor course, total 7 session exams and one final exam are given. After passing these session exams, the participants can download and print their ISO 13485:2016 Certified Internal Auditor training certificate.
4. Audit Checklist
   A complete set of more than 200 audit questions, both ISO 13485:2016 clause-wise as well as department-wise, is given as a ready tool to perform an internal audit. This ISO 13485:2016 audit checklist also helps participants to prepare for the final audit. The participants can download it for future reference and use it during the audit process of the organization.

COURSE OBJECTIVES

After completion of this Online ISO 13485 auditor training course, you will be able to:

• Familiarize yourself with ISO 13485:2016 quality management system requirements clauses and sub-clauses.
• Get an overview of ISO 13485:2016 quality management system (QMS) and the benefits to implement it.
• Familiarize yourself with the high-level structure and the framework of QMS.
• Understand general and structural requirements of ISO 13485:2016 standard.
• Know about the resource requirements and process requirements for QMS.
• Know about the management system requirements.
• Understand documentation and list of procedures and records to be maintained and to check them as an internal auditor.
• Get the knowledge of internal auditing and use of audit checklist.
• Understand the processes involved in auditing.
• Know about the types of auditing and questioning techniques.
• Understand how to prepare and maintain internal audit records.
• Get the ready-to-use internal audit checklist with clause-wise questions to perform an effective audit.
• Understand the new concepts of risk management and risk evaluation techniques, and process approach.
• Make a team of internal auditors to establish a quick and effective system for 13485:2016 accreditations.

WHO SHOULD ATTEND ISO 13485 ONLINE AUDITOR TRAINING COURSE?

This course is developed and brought to you by an ISO/IEC 17024 accredited training provider company, which offers various e-learning as well as classroom training courses for working professionals, college students, and other individuals for enhancing their career to new heights. Our e-learning courses help them to succeed in today’s competitive environment, to renew licenses, and to update, strengthen and add quality to their existing knowledge and skills. Our courses are also useful for those who want to get a certification, or start a new profession.

A team of our consultants having experience of more than 25 years in ISO and management consultancy in more than 35 countries across the world as well as expertise in designing and conducting various e-learning courses and training programs in convenient and cost-effective ways, has created this ISO 13485 online auditor training course.

STUDY MATERIALS

This e-Learning course is provided with study materials and you can read it after your log in or download (PDF format). Use the study materials to reinforce key points and to keep a reminder of what you already learned as well as you can save it in your computer for future reference. The access of this study material is removed after exam is cleared and on line certificate is prepared for the student.

EXAMINATION AND COURSE CERTIFICATE

This training program includes the Course Certificate that is issued upon course completion and passing the session exam as well as final exam given in the course with minimum 60% marks. The option to reappear in the exam is also given to student to get this course certificate

END OF COURSE INSTRUCTION

After completing the session and passing each session examination the student can appear for final exam. Once the final exam is cleared then it is considered a end of course. The training certificate is ready on our LMS and student can print it or save the training certificate. It is also available for verification by entering the name and certificate number.