This course aims to provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
Reference to existing CQI units/courses:
- MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner (PT219)
- MD-QMS ISO 13485:2016 Lead Auditor (PR369)
Who is it for?
This course is for those intending to acquire the competence to audit an organisation's entire MD-QMS against the European Union’s Medical Device Regulation (EU 2017/745), either as a third or second-party auditor.
1. Explain the background and purpose of a medical device quality management system (MD-QMS) in the context of EU MDR 2017/745 and confirm links with ISO 13485.
2. Explain the role and responsibilities of an auditor to plan, conduct, and report nonconformities for a quality management system audit in accordance with ISO 19011/ISO 17021 that uses the EU MDR 2017/745 requirements as the audit criteria.
3. Plan for and conduct an audit of a medical device quality management system to establish compliance with the EU MDR 2017/745 in accordance with ISO 19011/ISO 17021 as applicable and report on any nonconformities.
Recommended prior knowledge
- A good understanding of the EU MDR (2017/745) requirements and their application. This may be gained by successfully completing CQI and IRCA Certified MD-QMS Comprehensive EU-MDR 2017/745 Practitioner (PT219) course or alternatively a pre-course test may be required due to the complexity of the standard.
Successfully completion of a CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor (PR369) course.
Learners who have not successfully completed a CQI and IRCA Certified ISO 13485:2016 Lead Auditor training course (or acceptable alternative) that they are unlikely to successfully complete this 24-hour course.
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
- A working knowledge of risk-management principles related to the design of a medical device, through 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 1hr 40min 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 recommend acquiring it before booking on to a course.