Course Title: ISO 13485-Medical Devices-Quality
Management System ISO 13485-医疗设备质量管理体 系
Internal Auditor Training
内部审核员培训
CEU:
2.0
Prerequisites: None
Course Time Period:
You can take training at your own pace. You can logon
and logout as many times as needed. You can re-take the
exam as many times as necessary until you pass the exam
and an online certificate is issued.
Introduction简介
What are the general requirements for the ISO 13485
standard?
ISO 13485 标准有哪些基本要求?
What are the requirements for a ISO 13485 process
approach?
ISO 13485 过程方法的要求是什么?
How does ISO 13485 relate to other standards?
ISO 13485 与其他的标准有什么联系呢?
How is ISO 13485 compatible with other management
systems?
ISO 13485 同其他的管理体系怎样兼容呢?
ISO
13485
Auditing and Implementation in Chinese Final Exam
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Key Session Topics:
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ISO 13485 Internal Auditor
Training
Course Content:
-
Overview of the
ISO 13485 requirements
-
Auditing techniques and
methods
-
Records
-
Auditing/Implementations
Questions
-
Review Material based on
official standards
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Exams
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Certificate upon
completion of course
with passing scores
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