ATP Number: 01199876
ISO 13485:2016-Medical Devices-Quality Management System Lead Auditor Training Course
PR369 ISO 13485:2016 Lead Auditor (Course Code 2424)
Course Duration: 5 Day/ 40 hours
Course Description:
Successful completion of the course fulfils the formal training requirement for individuals seeking Third Party Assessments.
By the end of this course, you are expected to be able to get the:
Knowledge:
● 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
● 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 and ISO/IEC 17021.
Skills:
● 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.
Who Should Attend?
● A Third-Party Assessor or Lead Assessor of ISO 13485:2016
● Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
● Responsible for implementing internal audits and audit programs as per ISO 13485:2016
● Responsible for implementing the ISO 13485 series of standards
Eligibility Criteria:
Before starting this course, students are expected to have the following prior knowledge:
Management Systems:
● 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 Audit:
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 CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g., MD-QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner – PT219)
● A working knowledge of risk-management principles related to the design of a medical device, for example ISO 14971
How To Apply?
To apply for this course, please send us an email at trainings@alvinintegrated.com. Course confirmation will be given after receiving the advance payments from the interested participants. To learn more about our cancellation and refund policy, please visit the following link: cancellation-and-refund-policy/.
