ISO 13485 Foundation Training in Japan

ISO 13485 Foundation Certification Training Course Syllabus in Japan

Introduction to ISO 13485:2016

Importance of ISO 13485 for an organisation

An Overview of ISO 13485:2016 Requirement

General requirements & Documentation requirements

Management responsibility, Resources

Product realisation, Infrastructure, Risk Management

Implementation Phases of the ISO 13485 Frameworks

Stages to implementation, Gap Analysis, Process mapping

Conducting an ISO 13485 Certification Audit

The relationship between ISO 13485 and ISO 9001

How to Pass ISO 13485 Certification Examination in Japan

The duration of the ISO 13485 Foundation Training Course in Japan is carried out for one day.
After completing the training course, participants will:
  • • Gain a grasp over the functioning of Medical Devices Quality Management Systems
  • • Be able to establish a relation between ISO 13485 and other standards and frameworks
  • • Be able to align the recent methodologies and techniques that are followed to manage MDQMS.
There is no eligibility criterion to be met for taking up this course.
Holders of ISO 13485 foundation training course can pursue

ISO 13485 Lead Auditor Training in Japan and ISO 13485 Lead Implementer Training in Japan

or pursue jobs that advance their career.
The study material for ISO 13485 Training Course includes material that highlights the key areas of ISO standard, case studies and mock tests to assist participants to pass the exam in their first attempt.

Register for a free session with our trainer