Course description
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.
Upcoming start dates
Suitability - 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
Do you already have a good knowledge of ISO 13485:2016?
If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.
Outcome / Qualification etc.
- 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
Training Course Content
On completion of this training, participants will be able 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 in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
Course delivery details
- You will gain 40 CPD points on completing the course
- Course notes
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
Our expert teams provide top quality training to organizations of all sizes and every type of industry - ranging from leading multinationals to small, innovative start-ups and from governments to charities. From understanding how a standard can help your business,...