CQI & IRCA ISO 13485:2016 Lead Auditor Training for Medical Devices Online

Level Lead auditor Duration 5 days

Available to book: Live online classroom View dates and book now

From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit.

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification.

How will I benefit?

Identify the aims and benefits of an ISO 13485:2016 audit
Plan, conduct and follow up on auditing activities
Build stakeholder confidence by understanding the latest requirements
Gain 40 CPD points on completion of the course

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)
Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
This course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
As part of our CQI and IRCA accreditation requirements, BSI must ensure that delegates have the necessary prior knowledge before attending this course, as the requirements of the standard are not covered within this Lead Auditor Course. You should have good knowledge of ISO 13485:2016 and its key principles. If you do not have this knowledge, we strongly recommend attending our ISO 13485:2016 Requirements Course (tutor led or On Demand) prior to this training. Once enrolled, you will be provided with a prior knowledge check, which must be completed before the start of the course.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
  
  Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.

Let's shape your organization's future together

Reach out and see how we can help guide you on your path to sustainable operational success.

Get in touch