Lead Auditor Training 13485:2016

Gain the knowledge and skills you need to perform internal and external audits with our online and in-person Lead Auditor 13485:2016 training.
Comprehensive Approach
Two essential modules in integrated training.
Experienced Instructors
Recognized experts in international regulatory compliance.
Innovative Methodology
Dynamic and effective learning with practical integration.
Ongoing Support
Guaranteed post-training support for effective application.

Participate in Our Training and Be Prepared for Excellence in Quality.

In today's competitive business scenario, the search for excellence in quality is fundamental to the success and reputation of any organization. With Vesta Academy's ISO 14971:2020 training, you will be fully prepared to stand out as a professional capable of driving quality and efficiency in your company.

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Deep understanding of ISO 13485:2016

This includes the principles, requirements, terminologies, and intent of the standard.

Audit Planning

How to develop an effective audit plan, including defining audit objectives, scope, and criteria.

Conducting Audits

Includes techniques for conducting interviews, collecting and verifying information, making observations, and assessing compliance.

Audit Report

They learn to prepare clear, concise and relevant reports, indicating compliance and non-compliance with the standard.

Audit Follow-up

How to carry out follow-up activities, including evaluating the corrective actions implemented.

Management of an Audit Program

This includes managing resources, coordinating audit teams, and monitoring audit programs.

Communication skills

Effective communication is essential for auditing. This includes active listening skills, questioning and facilitating effective discussions.

Understanding the Regulatory Context

Understanding of regulations and regulatory requirements specific to the medical device industry.

Next modules after this training:

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VESTA ACADEMY is an Exemplar Global (formerly RABQSA) certified training provider. Participants who successfully complete this course receive an internationally recognized Certificate for completion of each Global Exemplary Knowledge Competency Unit. Are they:

01
QM

QM – Interpretation of ISO 13485:2016 - Quality Management System for medical and in vitro diagnostic devices.

02
AU

AU - Internal Auditor of Quality Management Systems for Medical Devices

03
TL

TL - Management Systems Lead Auditor

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