TRAINING CENTER

ICMC (International Certification Management Center Co., Ltd.)

GMP/ ISO 13485 Internal Auditor Training

GMP / ISO 13485 Internal Auditor Training (Quality management system basics / practical training)


Training Program Introduction

This course is to strengthen the ability to prepare for GMP and ISO 13485 certification and respond to internal/external audits through the theory and practice courses of GMP and ISO 13485 standards required for certification preparation.
Not only internal auditors, but also the latest industry trends and professional knowledge of related standards to foster experts in related quality management systems.




Training Program Purpose

1
Understand the latest industry trends and regulatory standards
2
Acquire GMP and ISO 13485 knowledge to prepare for certification audit
3
Learning internal and external audit response techniques
4
training talented individuals with expertise in quality management systems



Recommended To Whom

1
Those in the medical device field who are preparing for ISO 13485 (GMP) audit
2
Those who wish to work as a consultant specializing in quality management systems
3
Quality managers and internal practitioners (R&D, quality control, QA, RA, etc.) engaged in the relevant standard-related field
4
Those who wish to receive ISO practical and professional training
5
Those who want to be qualified as an internal auditor of a company
6
College students who want to become ISO 13485 auditors



Curriculum

Curriculum

※ Please note that the above curriculum is subject to change due to circumstances.




Education related matters

  • Completion criteria: 90 points for class attendance, 70 points for observation, 70 points or more for exams
    ※ Behavior that disturbs other trainees may be subject to sanctions, and if the severity is severe, you may be expelled.
  • Auditor registration: An auditor qualification certificate and card are issued and you can act as an auditor
  • Inquiries : 02-6226-9775