Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for the management and active teams, internal auditors and persons of interests in ISO 13485. This course will also provide understanding to first, second and third party auditors learn the ISO 13485:2016 auditing process.

Are you an existing auditor with knowledge of ISO 13485:2003 wishing to update your audit program in line with ISO 13485:2016? This course will refresh your auditing techniques and help you prepare to audit against the new requirements!

What will you be covering?

• An overview of the ISO 13485 requirements

• Comprehend implications of an increased focus on regulatory and statutory requirements

• Explain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.

• Understanding Internal audit planning process and execution

• Conduct an effective audit based on process identification, sampling and questioning

• Apply the process approach and Plan-Do-Check-Act (PDCA) methodology

• Those responsible for planning and scheduling an internal audit program for ISO 13485:2016 and those who must perform audits to ISO 13485:2013, medical device personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.