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
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Medical Device Regulatory Framework
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Classification of Medical Devices and Background of SS GDPMDS
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GDPMDS Requirements vs ISO 9001 Requirements: Clauses 1 to 14
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Workshop
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Plan and conduct an audit
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Report the audit
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Undertake audit follow-up activities