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

Level Lead auditor Duration 5 days

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BSI’s “Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016)” course teaches the principles and practices of effective quality management system audits against ISO 13485, in accordance with ISO 19011, “Guidelines for auditing management systems” and ISO 17021, as applicable. Experienced BSI tutors will guide delegates through the entire audit process, from initiating the audit through to conducting audit follow-up.

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.

How will I benefit?

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.

On completion, you’ll be awarded a CQI and IRCA certified training course certificate.
- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Consultants
As part of our CQI and IRCA accreditation requirements, BSI must ensure that delegates have the necessary prior knowledge before attend this course, as the requirements of the standard are not covered within this Lead Auditor Course. You should have good knowledge of ISO 13485 and its key principles. If you do not have this knowledge, we strongly recommend attending our ISO 13485:2016 Requirements course 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.
This training course is HRDF approved under the SBL scheme.

On completion, you will be awarded an internationally recognized BSI Training Academy certificate.

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