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ISO 13485 Medical Devices Internal Auditor Training

Medical Devices internal auditor

SGS Academy


£2,208 inc VAT
Study method
Online + live classes
2 days · Full-time
No formal qualification
  • Certificate of Completion - Free
Additional info
  • Exam(s) / assessment(s) is included in price
  • Tutor is available to students

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This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan.

Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.


Certificate of Completion

Digital certificate - Included


  • ISO 13485 Medical Devices Quality Management Systems Internal Auditor Course Synopsis -


The objective of this course is to provide delegates with the skills required to conduct internal audits as required by ISO 13485.

Upon completion of this course delegates will be able to :

Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC

  • 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 & sampling
  • Write factual reports on the compliance of the management system against the audit standards
  • Participate in the corrective action process

Who is this course for?

This course is designed to familiarise quality and regulatory professionals, engineers, designers and management with the requirements for internal auditing of ISO 13485 quality systems.

To gain the most from this training, delegates will require a copy of ISO 13485 as it will be reviewed and referred to during the training.


Whilst this is an introductory course, delegates are expected to have basic knowledge or awareness of quality management systems, such as one of the previous versions of the ISO 13485 standard. It is advisable to have read the ISO 13485:2016 standard prior to attending the course.

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Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

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An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.