ISO 13485:2016 Medical Device Quality Management Systems Lead Auditor Training Course

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)

Course Criteria - Objectives

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.

Prior knowledge 

Before starting this course, learners are expected to have the following 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 (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 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 MRD) Practitioner - PT 219)
  • A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971