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