The course is aimed at learners wishing to expand their existing management system knowledge and audit skills to include ISO 13485 and applicable international regulatory standards audits in accordance with ISO 19011, ISO/IEC 17021 requirements as applicable.
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.
1. Explain the purpose of a medical device single audit program (MDSAP) medical device quality management system audit process in the context of ISO 13485 and regulatory compliance.
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 17021, regulatory body requirements and the MDSAP audit criteria.
3. Plan for and conduct an audit of a medical device quality management system, report, and grade non-conformities to establish compliance with ISO 13485 and regulatory requirements using MDSAP methodology.
Recommended 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 (FD132) training course or equivalent.
Management systems audit
- Knowledge of management systems audit through satisfactory completion of a CQI and IRCA Certified Lead Auditor Training course (or acceptable alternative) in another discipline.
Learners who have not satisfactorily completed a CQI and IRCA certificated Lead Auditor training course (or acceptable alternative) in another discipline that they are unlikely to successfully complete this 24-hour course and will find the 40-hour CQI and IRCA Certified MD-QMS ISO 13485 Lead Auditor (PR369) course more appropriate.
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.
- A good working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including medical device regulations and regulatory auditing standards.
- 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.