CQI and IRCA Certified ISO 13485:2016 Lead Auditor Training Course (PR369)

Level Lead auditor Duration 5 days

Available to book: Live online training £2995 + VAT View dates and book now

Available to book: Duration 4 days Classroom-based training £2995 + VAT View dates and book now

Available to quote: In-house Request a quote

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety.

This course will help you 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.

CQI and IRCA course reference number: (PR369)

How will you benefit?

This course will help you:

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

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)
- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Consultants
As part of our accreditation with CQI and IRCA, BSI must demonstrate that delegates have the necessary prior knowledge to attend this course. The requirements of the standard are not explained in the Lead Auditor Course. Therefore, you will be provided with the link to a Prior Knowledge Check that must be completed before attending.

(Essential) You should already have a good knowledge of ISO 13485 requirements, and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485 Requirements course, or equivalent. It will also help if you have attended an internal auditor course, or have experience with conducting internal or supplier audits.
- On completion, you’ll be awarded a CQI and IRCA certified training course certificate.
- 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.

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