Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.
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. Acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
How will I benefit?
This course will help you:
- Identify the aims and benefits of an ISO 13485:2016 audit
- Interpret ISO 13485:2016 requirements for audit application
- Plan, conduct and follow-up auditing activities that add real value
- Grasp the application of risk-based thinking, leadership and process management
- Access the latest auditor techniques and identify appropriate use
- Build stakeholder confidence by managing processes in line with the latest requirements
- Understand the arrangements for BSI certification
Please note: The training is in English.
What will I learn?
You will learn to:
- Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
- Identify the purpose and benefits of an ISO 13485:2016 QMS
- Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course or ISO 13485:2016 Clause by Clause course first as there are particular requirements you need to understand before you can be an auditor. Note! The requirements of ISO 13485 are not taught in this training.
What is included?
- Access to the platform where classes will be held
- Access to the platform where the materials are posted
- On successful completion of the training, participants will receive an internationally recognized certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
