ISO 13485 Medical Devices Internal Auditor

Course details

Designed for individuals with quality and regulatory responsibilities; it also provides other professionals such as management, designers and engineers with the requirements for internal auditing of ISO 13485:2016 Medical Devices, quality management requirements for regulatory purposes.

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 19011:2011, “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.

Wales Quality Centre Certificates will be provided for this training.

This training can also be delivered in house contact us for details.

2 days.

Members: £650 + VAT
Non-Members: £795 + VAT



Our courses / events are bookable online. Click the calendar to see the full list and dates.

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