Main Attraction

ISO 13485 Lead Auditor training Course offered by TNV enables you to develop the required expertise to perform an efficient Medical Devices-Quality Management System (MD-QMS) audit using recognized audit principles, procedures, and techniques. Core Reference Standards: ISO 13485-2016, ISO 19011, ISO 17021-1.

Who Should Attend ISO 13485 Lead Auditors Training ?

*) Anyone willing to be Auditors or seek to perform and lead Medical Devices-Quality Management System (MD-QMS) certification audits (commonly called MD-QMS Audit for the Auditing Agencies). *) Managers or consultants seeking to learn/practice an Medical Devices-Quality Management audit process *) Individuals responsible for maintaining conformance with ISO 13485 requirements *) Expert/Professional in Medical Devices-Quality Management System

Why ISO 13485 Lead Auditor Training ?

This 40 Hours of training course enables you to acquire the knowledge and skills necessary to plan and carry out internal or external audits as per ISO 19011, ISO 17021-1 and Accreditation Requirements for the Certification process. Although, Auditing have different roles and this course enables you to participate in the ISO 13485 Audit in the capacity of Lead Auditor, Auditor, Audit Team member, which is, of course, based on your practical experience. As a qualified Lead auditor, you will grasp audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution like identification, raising, reviewing, closure of the findings, which is usually called Non-Conformities.

Training Objective

*) Understand the operations of a Medical Devices-Quality Management System (MD-QMS)based on ISO 13485 *) Recognize the correlation between ISO 13485 and other standards and regulatory frameworks. *) Understand an auditor’s role required for planning, leading and audit team, Preparation of the Report, Raising findings, and follow-up on a management system audit in accordance with ISO 19011, which is based on the requirement of ISO 13485. *) Learn how to lead an audit and audit team which is developed based on ISO 19011 and ISO 17021-1

Pre-requisite for the MD-QMS Lead auditor Training

All delegates should have reasonably good understanding and knowledge on Medical devices-quality management principles & concepts and basic requirements of ISO 13485:2016 (MD-QMS) audit process. TNV recommends students to read the applicable standards like ISO 13485:2016 as well as ISO 19011-2018 for a basic understanding of auditing techniques prior to attending this course. Knowledge of English and use of the online training tool like use of video telephony is essential

Content of Training Material

a. Reading Material PPT b. Slides Show c. Audio Clip d. Video Training e. Workshop f. Exercise g. Case Study h. Mock test

Reference Material

a. ISO 19011 b. ISO 17021-1 c. ISO 13485:2016 Standard d. Recorded Webinar

Exam Preparation Guide

An exam would be conducted on the following competencies: Competencies Criteria Auditing Skill: Planning the Audit, Conducting the audit Team Leadership Skill: Closing the Audit, Team Leadership, Managing their audit program ISO 13485 Standards: Fundamental, Principal, Concept, System Once you acquire the requisite expertise to perform this audit as defined in the curriculum of the TNV, you need to appear in the exam. You must obtain 70% marks to apply for an “Exemplar Global One year Graduate” or “Certified ISO 13485 Lead Auditor”. Once you acquire a Qualified Lead Auditor Certificate approved by Exemplar Global, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices. • Audit planning • Audit interview • Managing an audit program • Drafting audit reports • Drafting non-conformity reports • Drafting audit working documents • Documentation review • On-site Audit • Follow-up on non-conformities • Leading an audit team

Personal Certification

If you are participating in Certified Training Program under TPECS, you will get a Lead auditor Certification which Exemplar Global approves, and if you are applying under the RTP programme, you shall get a Certificate of Training in addition to this, you will be eligible to An Exemplar Global Graduate Certificate without any additional charge, whereas if you are applying for TPECS, you need to pay additional fees as applicable to Exemplar Global while registering under the graduate program. Every participant who successfully attends the training and passes the exam shall have access to the Alumni page of the TNV and shall have access to the study material as developed from time to time.

E-Learning – Online Learning

Due to Covid 19, working and education methods are drastically transformed, and now virtual working and training is considered a safe working method. Therefore, TNV offers an E-Learning option to the participants, which is audio-visual learning and provides flexible learning for the participants. Exemplar Global has approved our course after reviewing content to meet their competencies units for the personal certification. This course offers requisite reading and study material that comply with the requirement of ISO 17024 for online learning.

Global Recognition

Training offered by the TNV is certified by Exemplar Global. Exemplar Global is a Globally Recognized Certification body offer Personal Certification and Certification of Training Provider. Courses offered by TNV approved by Exemplar Global under TPECS / RTP). Every participant who attend the training and pass the exam get a Training Certification from the TNV with an Exemplar Global mark. Any candidates who pass the Lead Auditor Course as developed by TNV are eligible to be enrolled as Lead Auditor with any Certification body subject to fulfilment of other requirements like Educational Certificate and Experience. Core requirement is to attain a Lead Auditor Certificate from any training agencies duly approved by any recognized agencies and TNV fulfilling that requirement.

How will I benefit by the training?

• Identify the aims and benefits of an ISO 13485:2016 audit • Interpret ISO 13485:2016 requirements for audit application • Plan, conduct and follow-up auditing activities that add real value • Grasp the application of risk-based thinking, leadership and process management • Access the latest auditor techniques and identify appropriate use • Build stakeholder confidence by managing processes in line with the latest requirements

Training Duration

5 Days – 40 hours

Course Agenda

a. Agenda-01: Introduction to the Medical Devices-Quality Management System ISO/IEC 13485 b. Agenda -02: Audit principles, preparation, and initiation of an audit c. Agenda -03: On-site audit activities d. Agenda -04: Closing the audit e. Agenda -05: Certification Exam