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MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System)

Course code

Minimum of 40 hours


This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

Reference to existing CQI units/courses:

  • MD-QMS ISO 13485:2016 Foundation (FD132)

Who is it for?

This course is for those intending to acquire the competence to audit an organisation's entire MD-QMS to meet the requirements of ISO 13485, either as a third or second-party auditor. 

Learning outcomes


1. Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.

2. Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011, ISO/IEC 17021.


1. Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

Recommended prior knowledge

ISO 13485

  • Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) course or equivalent.

Medical device management systems

Knowledge of the following quality management principles and concepts:

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.
  • The process approach used in MD-QMS.
  • A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.  This knowledge may be gained by successfully completing a course relating to individual regulatory authority standards for example a CQI and IRCA Certified MD-QMS EU-MDR 2017/745 Auditor (PR371).
  • A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971.


Learners must demonstrate acceptable levels of performance in the three learning objectives to complete the course successfully. Learners will be assessed through practical tasks and activities. Learners must also pass a 2-hour written examination.

Assessment questions may relate to prior knowledge that will not be covered in this course. Learners who lack the prior knowledge are strongly recommended to acquire it before booking on to a course.

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