ISO 13485:2016 Medical Device Quality Management Systems Lead Auditor Training Course
Virtual delivery, IRCA Accredited
SGS Academy
Summary
- Exam(s) / assessment(s) is included in price
- Tutor is available to students
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Overview
The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.
Resources
- ISO 13485 Medical Devices Quality Management Systems Lead Auditor -
Description
Upon completion of this course, learners will be able to:
- Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, 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 in accordance with ISO 19011 (and ISO 17021 where appropriate);
- 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.
Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.
Who is this course for?
This course is designed for learners who have prior knowledge of medical device quality management principles, concepts, the requirements of ISO 13485 plus requirements of regulatory authorities.
This course is not designed as a foundation or introductory course.
Requirements
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 (FD 132) course or equivalent.
Medical Device management System Audit
- 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 risk management principles related to the design of a medical device, for example ISO 14971
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