Internal Auditing for ISO 13485 2016 Medical Devices

Internal Auditing for ISO 13485 2016 Medical Devices

Internal Auditing for ISO 13485:2016 Medical Devices: Level 3 Award in Principles of Effective Auditing and Inspection (RQF accredited course)

ISO 13485:2016 is the Standard for the manufacture of medical devices and Clause 8.2.2 contains the requirement for a system for internal auditing. The organisation shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organisation, and b) is effectively implemented and maintained.

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

This Ofqual-regulated RQF accredited course develops the necessary skills to assess and report on the conformance and implementation of processes based on ISO 15189. You’ll learn how to initiate an audit, prepare and conduct audit activities, compile and distribute audit reports and complete follow-up activities.

What will we learn?

  • The importance of undertaking effective auditing
  • The competencies and characteristics of an effective auditor
  • The importance of a planned approach to conducting effective audits
  • Understand the techniques used during the audit process
  • Understand how to analyse and use evidence collected to inform the audit process
  • Guidelines of management system auditing according to ISO 13485:2016
  • Application of auditing guidelines to ISO 13485:2016
  • Initiating, preparing and conducting audit activities
  • Preparing and distributing the audit report
  • Completing audit and follow-up

How will we benefit?

This course will help you to:

  • Prepare, conduct and follow-up ISO 13485:2016 audit activities
  • Identify the benefits and requirements of an ISO 13485:2016 audit
  • Gain the skills to assess an organisation’s capability to manage its QMS
  • Be able to write factual audit reports and suggest corrective actions


The course concludes with a one-hour examination which consists of 30 multiple choice questions. The examination is an Ofqual regulated qualification and success leads to learners achieving the RQF qualification.


Times 6 classroom learning hours plus two-hour revision and examination session held on one day

Preliminary tasks yes

Fees as arranged with you

Venue Your venue or our Ringwood centre. A comfortable training room is all that is needed

Duration One day with preliminary tasks

Maximum attendees: we prefer no more than 12 (there is no minimum number for the course)

Available from: this is a new qualification on the RQF framework, launched in November 2017

This course is part of the range of ISO Internal Auditing Courses from Aaron Scott and Black