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ISO 13485:2016 Medical Device QMS Lead Auditor Training Course (CQI and IRCA Certified)

Gain the knowledge and skills to perform audits against medical devices quality management systems (MD QMS).

This certified course (2428-PR 369) will equip you with the knowledge and skills required to perform audits of MD QMS against ISO 13485:2016, in accordance with ISO 19011 and ISO 17021, as applicable.

SGS is a designated UKCA Approved body, a CE Notified Body and a recognized MDSAP Auditing Organization providing accredited training courses and extensive testing capabilities across all Medical Device categories.

Course Details

On completion of this course, you will be able to:

  • Explain the purpose of a MD QMS, its interaction with appropriate medical device regulatory authority requirements, QMS standards, third-party certification, and the business benefits of the QMS
  • Explain the role and responsibilities of a Lead Auditor in the planning, conduct of, report on and follow-up for a QMS audit in accordance with ISO 19011, and ISO 17021 where appropriate
  • Plan, conduct, report, and follow-up an audit of a MD QMS to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011 and ISO/IEC 17021

In order to adapt to you learning style and needs, this course is available as Classroom Based or Virtual Instructor Led Training (VILT). Depending on the selected method, this course can be delivered over 5 days, 40 hours or in shorter online sessions, and will conclude with an exam.

Course Certification

CQI IRCA Certified Course Logo 450px

To complete this training course you will be required to pass both an examination and continuous assessment before you are issued with a Certificate of Achievement that satisfies the formal training for an individual seeking certification as a CQI/IRCA auditor/lead auditor. The Certificate of Achievement is valid for a period of five years from the date of the exam for the purpose of certification as an auditor with the CQI/IRCA.


Before starting this course, you are expected to have the following prior knowledge:

  • Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent
  • Medical Device Management System Audit, the process approach and the plan-do-check-act (PDCA) cycle:
    • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices
    • Commonly used quality terms and definitions within ISO 13485 and ISO 9000
    • A working knowledge of medical device regulatory processes applicable to countries the learner is located in, including device regulations, regulatory auditing standards and their relationship with ISO 13485
    • A working knowledge of risk-management principles related to the design of a medical device, for example ISO 14971

Note: Examinations may include questions relating to prior knowledge

Trusted ISO 13485 Training from a Leading Course Provider

As a leader in professional training, we draw on years of global experience. Our courses are delivered in multiple languages and locations by approved tutors, specialists in the area who can support you on your professional journey.

Contact us today to enroll on the SGS Academy ISO 13485 Medical Devices Lead Auditor training course.

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