CQI and IRCA Certified Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016) (PR350)

Niveau Lead auditor Durée 5 journées de formation

Disponible pour réserver: Salle de classe virtuelle 4010€ + TVA View dates and book your training

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”.

Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

Please note that this training will be held in English!

Prerequisites

Before attending this course, delegates are expected to have:

Knowledge of the following quality management principles and concepts:
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between quality management and customer satisfaction
- Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
- The process approach used in quality management
- The Model of a Process Based Quality Management System, the structure and content of ISO 13485

Knowledge of the requirements of ISO 13485

It is advisable that delegates have either attended an internal auditor course or had experience with conducting internal or supplier audits.

Pedagogical objectives

Successful completion of this CQI and IRCA certified training course by passing the relevant CQI and IRCA examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit.

- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Consultants
Upon completion of this training, delegates will be able to:
- Describe the purpose of a quality management system, of quality management systems standards, of management system audit and of third-party certification
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: ISO 13485 CQI/IRCA Certified Lead Auditor - International
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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