ISO 13485:2016 Medical Device - Quality Management Systems Internal Audit

Description

*** SGS also provide e-certificate and e-document (e-document will be provided for In-house training only). This enables leaners to be free from certificate loss, to reduce storage space, and ultimately to be environmental-friendly to which SGS’s current policy is attached.***

The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of to ISO 13485:2016 and to contribute to their continual improvement. This intensive training aims to provide delegates with the skills required to conduct internal audits, using interactive training by medical device lead auditors experienced in ISO 13485 and Notified Body audits.

Objectives

• Understand the requirements of ISO 13485:2016
• Know how to conduct internal quality system audits
• Understand the role of internal audit in the maintenance and improvement of management systems
• Plan and prepare for an internal audit
• Learn to gather evidence by observation, questioning and sampling
• Write factual reports on the compliance of the management system against the audit standards
• Participate in the corrective action process

Audience

Recommended for anyone who involved in medical device manufacturing