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ISO 13485 Lead Auditor

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ISO 13485 Lead Auditor Certification

This certification provides an in-depth understanding of ISO 13485, covering the requirements for establishing and maintaining a quality management system for medical devices. It explores essential areas such as quality management system structure, audit processes, corrective and preventive actions, and risk management. Delegates will gain practical knowledge to apply these standards effectively in the medical device industry through various exercises and real-world examples.


What You Will Learn?

ISO 13485 Lead Auditor Certification offers several benefits, including enhanced career opportunities in the medical device industry by demonstrating expertise in quality management systems. Certified auditors are equipped to conduct thorough assessments, ensure compliance, and drive continuous improvement within organizations. The certification also provides a competitive edge, boosting credibility and recognition as a skilled professional in regulatory and quality management processes.

Introduction to ISO 13485:2016

Conducting an ISO 13485 Certification Audit

ISO 13485 and Quality Management Systems

Lead Auditor Responsibilities

Medical Devices, Quality, and Auditing Terminology

Planning, Preparation, and Management of Audits

Preventative Action


Enhance Your Expertise

Gain in-depth knowledge and globally recognized credentials to advance your career.

Stay Competitive

Keep up with industry trends and best practices across various professional domains.

Flexible Learning Options

Choose from online, self-paced, or instructor-led training tailored to your needs.

Globally Recognized Certifications

Earn certifications accredited by leading industry bodies for career growth.

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Frequently Asked Questions

Yes, this training course has been accredited by Global Certification Board, and it also includes an exam which is conducted at the end of the training program.

Yes, we have subject matter experts who will work according to your company requirements.

A certification from a Global Certification Board enhances credibility, validates expertise, and increases career opportunities. It demonstrates commitment to professional growth, improves job prospects, and boosts confidence in applying industry best practices.

Yes, you will receive the e-certificate after passing the exam.