ISO 13485 Medical Devices Internal Auditor course


2 Day(s)


Medical Devices ISO 13485

What You Will Gain

The course provides the principles and practices of effective internal audits in accordance with the ISO 13485:2016 and refers to ISO 19011:2018, “Guidelines for Quality and Environmental Management Systems Auditing.” Delegates gain auditing skills through a balance of formal classroom tutorials, practical group workshops, and open discussions.

Day 2 of the course will concentrate on auditing practice using a case study specifically developed for medical device approvals.
• Understand the requirements of ISO 13485:2016
• Internal, external and third party auditing
• The essential steps and techniques required for Quality Management System auditing, from planning through audit and follow up.
• Write factual reports on the compliance of the management system against the management standard and function immediately as a member of a Management Systems audit team
• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
• Assist in the effective management of risk
• Where appropriate, improve processes and efficiencies.

Who Should Attend?

• Those with regulatory responsibilities for medical devices
• Individuals conducting, managing or participating in first-party and second-party internal audits

• Quality Assurance Professionals, Engineers and ISO Coordinators and Laboratory Quality Professionals.

For organisations that already have or intend to achieve UKAS accredited registration to ISO 13485:2016 this course meets the training requirements as a Quality Management System Internal Auditor for Medical Devices ISO 13485:2016. UKAS accredited registration bodies will accept this training as appropriate.

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