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ISO 13485 Lead Auditor Self-Study Training Course

A training of SGS Academy

About the Course

The ISO 13485 Lead Auditor self-study training course is certificated by PECB and meets the requirements of the PECB Examination and Certification Program (ECP). This training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques. Based on practical exercises, learners will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution

International Certifications

What Will You Gain from This Course?

Fundamental Principles of MDQMS
Introduction to the Medical Devices Quality Management System (MDQMS). Key principles and concepts for ensuring quality in medical devices.
Audit Fundamentals
Understanding the fundamental concepts and principles of auditing. Essential guidelines for conducting effective audits.
ISO 13485 Audit Process
How to prepare, conduct, and close an ISO 13485 audit. Step-by-step guidance for each phase of the audit process.
Managing an ISO 13485 Audit Program
Best practices for managing and overseeing an ISO 13485 audit program .Strategies to ensure continuous improvement and compliance.

Precio Normal

$997.000COP

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    What's Included?

    Online
    Spanish Audio
    Spanish, English
    Level: Advanced
    Limited Access
    16 Hours

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