ISO 13485:2016 Lead Auditor Training CourseBSI Group
Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.
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. Acquire the skills to initiate, plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
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Who should attend?
- Anyone with the need to audit an organization’s ISO 13485:2016 QMS like:
- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
Delegates will be able to:
- identify the purpose and benefits of an ISO 13485:2016 QMS
- explain the role of an auditor to plan, conduct, report and follow up an 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)
The ISO 13485:2016 Lead Auditor learning path is modular. You can follow the training in all combinations. We recommend the following order:
- The Lead Auditor is an intensive training course and will be completed by an official BSI exam
- It's a 5-day course (first days at least till 18:00)
- The training and materials will be provided in English
- Lunch and drinks are included.
- There is a requirement for delegates to undertake some evening preparation or assignments on days 1-4 (Approximately 2-3 hours)
The price of this training course is € 3250,-
Examen, diplom m.m.
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
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