
Description
The course aims to impart the skills and knowledge in conducting internal audits against GDPMDS and the relevant guidance documents.
Objectives
This 2-Day course is designed primarily to provide participants with the knowledge and skills required to perform internal audits of the SS GDPMDS standard, in accordance with ISO 19011.
The delegates will understand the key changes in SS 620: 2016 and reference to relevant guidance documents.
Course Content
Medical Device Regulatory Framework
Classification of Medical Devices and Background of SS GDPMDS
GDPMDS Requirements vs ISO 9001 Requirements: Clauses 1 to 14
Workshop
Plan and conduct an audit
Report the audit
Undertake audit follow-up activities
Audience
Managers / executives / personnel who are involved in organizing and conducting internal audits for GDPMDS
Personnel who are involved in the implementation and maintenance of SS GDPMDS or those who wish to know more about the specification and its requirements.
