ISO 13485 Lead Auditor Training (Medical Devices Quality Management System)

This five-day program will empower you to develop necessary expertise for auditing a Quality Management System (QMS) for Medical Devices with Medical Devices Quality Management System (MDQMS) manufacturers. By learning a wide variety of auditing principles and technique, you will be able to manage a team of auditors. 

You will learn to perform internal and external auditing in compliance with ISO 17021-1 and ISO 19011. You will also learn to manage MDQMS audit team on account of the new skills you wil learn in this program. Finally, you will be able to relate Medical Devices Quality Management System and compliance with customer and regulatory requirements

Outline:

Day 1: Introduction to Medical Devices Quality Management System (QMS) concepts as required by ISO 13485

Day 2: Planning and Initiating an ISO 13485 audit

Day 3: Conducting an ISO 13485 audit

Day 4: Concluding and ensuring the follow-up of an ISO 13485 audit

Day 5: Certification Exam

Features:

- Training is both theory and practice-based

- Real cases will be discussed during the training

- Practice test is included to familiarize you with exam

- Review exercises included

- Student manual will be provided with information and practical examples for you

- Under certain conditions, the students are allowed to re-take the exam in case of failure.

Certificate:

1. A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion.

2. Once the exam is passed and you comply with all requirements for this credential, another certificate will be provided to you.

Note: Certification and exam fee included in the price. (Pricing are subject to change without any prior notice)

Credentials:

Depending on your level, you can apply for the following credentials after completing the exam;

- Certified ISO 13485 Provisional Auditor

- Certified ISO 13485 Lead Auditor

- Certified ISO 13485 Auditor