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

Level Lead auditor Duration 5 days

Available to book: Public classroom View all dates and book

Available to quote: In-house Request a quote

This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.”

Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

What are the benefits?

Benefit from effective ISO 13485 audits and compliance
Maintain and improve quality standards with regular audits
Be confident that your organisation can rely on ISO certified lead auditors
Increase credibility and competitive advantage
Motivate employees through CPD and build your customer base.

On completion of this training, participants will be able to:
- Interpret the requirements of ISO 13485 in the context of an audit
- Describe the purpose of a quality management system and explain the 8 principles of quality management
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
- Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
- Manage the duties of a lead auditor in their organization or for a third-party
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 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.
- Refreshments
- Lunch
- Training course notes
- Pen

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