QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This course provides the skills and knowledge that auditors need to develop to conduct effective and value-added audits, both internally and externally. The course is conducted over 4½ days.

During the training, participants will learn how to plan and prepare for audits utilizing case studies that simulate supplier and third-party audits. They will actively engage in simulated audit exercises covering planning, preparation, and evaluation of evidence, and practice applying ISO 13485:2016 and MDSAP requirements.

The course consists of four days of interactive instruction and auditing sessions, culminating with a comprehensive written examination on the fifth day. The course requires highly interactive work and ongoing instructor assessment throughout the week.

The exam is proctored, and participants will have two hours to complete it. Additional time will be provided to individuals who speak English as a second language (and are taking the exam in English) and/or individuals with disabilities that may prevent them from completing the exam within the two-hour timeframe.

This course is not an IRCA- or ANAB-accredited course. A certificate of completion will be issued to participants who actively participate in all four days of the training session and successfully pass the examination.

The course was developed by regulatory and quality experts with FDA and/or Notified Body experience. It is updated regularly to reflect changes to both ISO 13485 and the MDSAP criteria.

Prior Knowledge Requirements

Participants are required to demonstrate that they fulfil the prior knowledge requirements for this course, including knowledge of the following:

• The requirements of ISO 13485:2016.
• Quality management principles and concepts, including:
  • The Plan-Do-Check-Act (PDCA) cycle.
  • The relationship between quality management and customer satisfaction.
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000, including the seven quality management principles described in ISO 9000.
  • The process approach used in quality management.
  • The model of a process-based quality management system, and the structure and content of ISO 9001.
• Knowledge of at least one MDSAP country-specific regulation or a similar regulatory framework, such as WHO Prequalification (PQ) requirements, the EU Medical Device Regulation (EU MDR), or the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR).
• Medical device and/or in vitro diagnostic (IVD) auditing experience.

Learners will receive a pre-course questionnaire via email to share prior knowledge and experience, which must be completed and returned prior to the course date.

Tutor

This training will be delivered by one of our experts –  click here to learn more .